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Cancer Medicine logoLink to Cancer Medicine
. 2023 May 28;12(13):14584–14611. doi: 10.1002/cam4.6050

Components and effectiveness of patient navigation programmes to increase participation to breast, cervical and colorectal cancer screening: A systematic review

Isabel Mosquera 1,, Adam Todd 2, Mirza Balaj 3, Li Zhang 1, Sara Benitez Majano 4,5, Keitly Mensah 1, Terje Andreas Eikemo 3, Partha Basu 1, Andre L Carvalho 1
PMCID: PMC10358261  PMID: 37245225

Abstract

Background

Inequalities in cancer incidence and mortality can be partly explained by unequal access to high‐quality health services, including cancer screening. Several interventions have been described to increase access to cancer screening, among them patient navigation (PN), a barrier‐focused intervention. This systematic review aimed to identify the reported components of PN and to assess the effectiveness of PN to promote breast, cervical and colorectal cancer screening.

Methods

We searched Embase, PubMed and Web of Science Core Collection databases. The components of PN programmes were identified, including the types of barriers addressed by navigators. The percentage change in screening participation was calculated.

Results

The 44 studies included were mainly on colorectal cancer and were conducted in the USA. All described their goals and community characteristics, and the majority reported the setting (97.7%), monitoring and evaluation (97.7%), navigator background and qualifications (81.4%) and training (79.1%). Supervision was only referred to in 16 studies (36.4%). Programmes addressed mainly barriers at the educational (63.6%) and health system level (61.4%), while only 25.0% reported providing social and emotional support. PN increased cancer screening participation when compared with usual care (0.4% to 250.6% higher) and educational interventions (3.3% to 3558.0% higher).

Conclusion

Patient navigation programmes are effective at increasing participation to breast, cervical and colorectal cancer screening. A standardized reporting of the components of PN programmes would allow their replication and a better measure of their impact. Understanding the local context and needs is essential to design a successful PN programme.

Keywords: breast cancer, cervical cancer, colorectal cancer, components, effectiveness, patient navigation, screening

1. INTRODUCTION

In the last decades cancer incidence and mortality have been increasing worldwide, across high‐ and low and middle‐income countries (LMIC). 1 One approach that has been shown to reduce breast, cervical and colorectal cancer‐related mortality at a population level, is cancer screening. 2 , 3 , 4 For cancer screening to be as effective as possible, it is important that screening programmes reach high coverage of the target population. This is achieved with screening programmes easily accessible and available to everyone – regardless of their socioeconomic position.

Several interventions have been described to promote equitable cancer screening and reduce structural barriers related to access (e.g., the use of mobile units), but one approach that is gaining significant interest is patient navigation. In 1990 Freeman developed patient navigation to assist low‐income women in USA to overcome barriers to follow‐up after an abnormal breast cancer screening result. 5 As patient navigation began to take shape, it was implemented in the screening of other cancer sites, at different levels of the cancer screening continuum and for other socially disadvantaged groups. Therefore, a patient navigation intervention is by default designed to improve access among hard‐to‐reach populations. Moreover, the patient navigation approach is focused on supporting people to overcome barriers and has the following characteristics: (i) occurs within a specific cancer care event (e.g., one‐time screening), (ii) follows the individual until a specific endpoint is reached (e.g., a definitive diagnosis), (iii) targets the health services needed to achieve the endpoint (e.g., screening and/or diagnostic care), (iv) addresses barriers at a health system, individual, educational, and/or social and emotional level, and (v) aims to reduce delays in cancer care access and uptake. 6

As the evidence for patient navigation developed, DeGroff et al. (2014) outlined 10 key components that should be considered when designing a patient navigation programme: (1) identification of a theoretical framework and establishment of programme goals, (2) specification of the community characteristics, (3) determination of the point(s) of intervention in the cancer care continuum, (4) establishment of the setting where navigation is provided, (5) description of the services offered and the patient navigator responsibilities, (6) determination of the background and qualifications of navigators, (7) selection of the communication method between individuals and navigators, (8) design of the patient navigator training, (9) establishment of the supervision of navigators, and (10) evaluation of patient navigation. 7

Previous systematic reviews have described the positive impact that patient navigation interventions have on improving screening participation for breast, cervical and colorectal cancer, although it is acknowledged most of these studies have been conducted in the USA. The literature has reported increased participation in patient navigation programmes when compared to control (as usual care) as well as other types of interventions. 6 , 8 , 9 Although the previous reviews have been helpful to extend our understanding in this field and summarize a complex evidence base, the definition used by the studies to conceptualize a patient navigation intervention is wide‐ranging and varied. This is challenging, given interventions might be based on the concept of patient navigation, but may not necessarily use this term to describe them. To the best of our knowledge, a comprehensive review on patient navigation programmes using a framework guided by the key components outlined by DeGroff et al. has not been undertaken. This work sought to address this gap by identifying the reported components of patient navigation to consider when conceptualizing patient navigation, and by assessing the effectiveness of patient navigation programmes to promote breast, cervical and colorectal cancer screening.

2. METHODS

A systematic search of the literature was conducted in Embase, PubMed and Web of Science Core Collection databases in March 2020 and then updated (January 2021). The search was limited to papers published since 2000 (as previous literature was considered not relevant to our purpose) without language restriction. The search strategies combined Medical Subject Headings and free text terms regarding screening, breast, cervical and colorectal cancer, interventions, participation and social inequalities. As an example, the search strategy used in Web of Science Core Collection is presented in Appendix 1.

The population considered was all people eligible for breast, cervical or colorectal cancer screening as defined by the eligibility criteria for that screening. The screening methods considered were those recognized and validated in IARC (International Agency for Research on Cancer) handbooks. 10 , 11 , 12 Interventions were patient navigation programmes that aimed to increase access to cancer screening. Although we did not require studies to identify their intervention as patient navigation, we included only those where the intervention was individualized and ready to address some type of barrier, specifying it or not. The outcome was participation in cancer screening comparing patient navigation against usual care or other interventions. Screening participation could be extracted from health service records or as a self‐report. Included study designs were controlled trials, cohort studies, repeat cross‐sectional studies, case–control studies, before‐after studies and after only studies. Studies that were not original, reported several interventions or interventions targeting only populations at high risk of developing cancer (e.g., genetic/familial disorders) were excluded from the review.

Inclusion and exclusion criteria were piloted in 100 references before their application to the whole set of identified references, discussing any discrepancies until a consensus was reached among researchers. Two researchers (IM and LZ) independently assessed titles and/or abstracts of the identified references using Covidence software, with a third (AC) in case of discrepancy. Two researchers (IM and LZ) read 40% of the full‐text references and Cohen's Kappa statistic was used to measure the interrater reliability (IRR). As Kappa was higher than 0.7, the first reviewer assessed the remaining references.

After the selection of the included studies, the following information was extracted for each study and included in an Excel spreadsheet: period of analyzed data, country, cancer site, components of patient navigation 7 – ‘theoretical framework’, ‘programme goals’, ‘community characteristics’, ‘point of intervention’, ‘services provided’, ‘communication method’, ‘navigator background and qualification’, ‘training’, ‘supervision’, and ‘monitoring and evaluation (other than screening participation)’ – participants – number, age group and percentage of females when applicable – measure of socioeconomic position of the population included and measure of socioeconomic position in the analysis if applicable, study design, comparison, screening method and main findings – outcome, including baseline characteristics.

The components of patient navigation examined were 14 instead of the 10 described by DeGroff et al., 7 as ‘theoretical framework and programme goals’ were broken down into two components, and ‘services provided’ by patient navigators were divided into four components based on the categories of barriers addressed. These categories were: (a) health system barriers (including scheduling appointments, paperwork and patient‐provider communication), (b) individual barriers to cancer screening (lack of transportation, financial and insurance barriers, lack of childcare or language translation, low health literacy or low literacy), (c) educational barriers related to cancer and screening and (d) social and emotional barriers. 6

The data extraction was carried out by one reviewer (IM or SBM) and revised and completed by a second reviewer (SBM or IM). Disagreements were resolved by open discussion. If a consensus was not reached, a third reviewer was consulted (AC), and the majority decision was followed. In studies providing screening participation rate, the percentage increase in participation following the intervention was calculated.

The methodological quality of the included studies was assessed independently by two reviewers (IM and KM) through the application of the study quality assessment tools of the National Heart, Lung and Blood Institute for quantitative studies. 13 Studies were classified into three quality categories (good, fair and poor) based on criteria regarding study design, including randomization, blinding, drop‐out and outcome measures, among others. Discrepancies were reconciled through discussion.

A meta‐analysis of the studies was planned, but their heterogeneity hindered this, and findings were synthesized by means of a narrative synthesis. 14 The systematic review was registered with PROSPERO (CRD42020193657).

3. RESULTS

The initial systematic search identified 5540 references to screen after taking out duplicates, and the updated search found an additional 308 references. After the application of inclusion and exclusion criteria, 5508 references were deemed not relevant for the topic of interest, resulting in 340 references selected to be read full text. Finally, 51 references on patient navigation were included (Figure 1), corresponding to 44 studies.

FIGURE 1.

FIGURE 1

Study selection flow diagram.

Studies on ‘patient navigation’ rarely defined this term. Most studies were randomized controlled trials and assessed colorectal cancer screening participation (Appendix 2). 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 Participant numbers ranged from 49 49 to 28,929. 24 , 25 The most common measure of socioeconomic position was ethnicity/race, 16 , 17 , 22 , 26 , 27 , 28 , 32 , 38 , 40 , 41 , 44 , 47 , 48 , 50 , 51 , 52 , 58 , 59 , 62 , 64 followed by income, 15 , 20 , 31 , 39 , 48 , 49 , 51 , 52 , 59 , 63 and geographic area. 8 , 18 , 19 , 24 , 25 , 31 , 32 , 45 , 46 , 59 Other measures used were health insurance, 15 , 30 , 41 , 48 , 52 , 59 , 64 primary language, 21 , 29 , 30 , 39 , 40 , 59 , 64 language preference, 61 education, 52 health literacy, 15 , 18 , 19 , 26 , 45 , 46 , 50 employment, 49 material deprivation 24 , 25 or socioeconomic status. 32

The screening methods evaluated were mammography 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 and clinical breast examination 47 for breast cancer, cytology 8 , 54 , 56 , 57 , 58 and HPV self‐sampling 56 , 57 for cervical cancer, and fecal occult blood test (FOBT), 15 , 16 , 17 , 18 , 19 , 21 , 22 , 23 , 24 , 25 , 26 , 29 , 30 , 32 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 42 , 43 fecal immunochemical test (FIT), 31 , 41 colonoscopy, 17 , 20 , 21 , 22 , 23 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 42 , 43 sigmoidoscopy, 21 , 22 , 23 , 26 , 29 , 30 , 32 , 33 , 34 , 35 , 36 , 37 , 39 , 40 , 43 barium enema 21 , 29 , 30 , 32 , 34 , 35 , 36 , 37 , 38 , 39 , 40 and virtual colonoscopy 32 for colorectal cancer screening. Studies were carried out mainly in the USA, although studies from other geographic areas (Australia, 54 Canada, 58 France, 24 , 25 UK 56 , 57 and Zambia 55 ) were also identified.

The quality of the included studies was mainly rated as poor (Appendix 2). The most frequent shortcomings were a lack of, or not reporting the justification of the sample size, a concealed allocation and a drop out higher than 20%.

3.1. Components of patient navigation

Most studies (n = 37, 84.1%) had at least 9 out of 14 components of patient navigation. All studies described the goals of the navigation programme, community characteristics and point of intervention (Table 1, Appendices 3 and 4). Programme goals were generally to increase screening participation among disadvantaged populations.

TABLE 1.

Components of patient navigation programmes described in the included studies.

Components of patient navigation programme Overall N (%)
Programme goals 44 (100)
Community characteristics 44 (100)
Point of intervention 44 (100)
Setting 43 (97.7)
Monitoring and evaluation (other than screening participation) 43 (97.7)
Communication 42 (95.5)
Background and qualifications 35 (81.4) a
Training 34 (79.1) a
Address educational barriers 28 (63.6)
Address health system barriers 27 (61.4)
Theoretical framework 21 (47.7)
Address individual barriers 21 (47.7)
Supervision 16 (36.4)
Address social and emotional barriers 11 (25.0)
a

Excludes one study where this component was not applicable.

Studies were conducted predominantly among hard‐to‐reach populations, although there were studies with primary care patients, 23 , 31 , 34 , 35 , 36 , 42 , 51 general target population, 24 , 25 , 55 , 56 , 57 and with population living in an area with relatively unrestricted accessibility to resources. 54 The majority of the studies targeted populations not up to date with screening. 8 , 17 , 18 , 19 , 21 , 22 , 23 , 27 , 29 , 30 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 42 , 44 , 45 , 46 , 47 , 56 , 57 , 58 , 61 , 63 , 64

Patient navigators were located mainly at a primary care or community level, 8 , 15 , 16 , 17 , 18 , 19 , 21 , 22 , 23 , 26 , 27 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 50 , 51 , 55 , 56 , 57 , 58 , 60 , 61 , 63 , 64 and communicated with participants through phone calls. 8 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 36 , 37 , 38 , 39 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 58 , 59 , 61 , 62 , 63 , 64 In some cases they met in person, 8 , 18 , 20 , 24 , 25 , 28 , 39 , 42 , 44 , 45 , 46 , 47 , 49 , 50 , 51 , 55 , 58 , 62 and/or sent lette rs, 22 , 24 , 25 , 50 , 51 , 52 , 56 , 61 , 62 e‐mails 20 , 23 , 56 , 59 or text messages. 56 , 59 Regarding the services they provided, 27 studies (61.4%) described them addressing health system barriers, as scheduling appointments, 18 , 20 , 23 , 30 , 32 , 33 , 34 , 39 , 40 , 42 , 44 , 47 , 50 , 53 , 56 , 58 , 61 , 62 sending reminders, 15 , 16 , 18 , 19 , 20 , 21 , 27 , 32 , 34 , 35 , 37 , 38 , 39 , 40 , 42 , 45 , 46 , 56 , 61 , 62 , 63 , 64 completing paperwork, 62 or communicating or supporting communication with providers. 20 , 44 , 50 , 62 In 21 studies (47.7%), they approached individual barriers, through assistance in transportation, 20 , 27 , 39 , 40 , 47 , 53 , 58 , 62 , 64 escorting to appointments, 20 , 30 , 39 , 40 , 44 , 49 , 50 , 55 , 64 or arranging the care of dependents during the appointment. 62 Language 39 , 40 , 47 , 52 , 58 , 63 and financial barriers 30 , 62 were also addressed by navigators. Four studies (9.1%) did not specify what type of barriers they helped approach. 26 , 43 , 48 , 59 Navigators were reported to provide education in 28 studies (63.6%), but only 11 (25.0%) described social and emotional support.

The background and qualifications of the navigator were described in 35 studies (81.4%). Most of them referred the navigators' language, culture or ethnicity (generally because it being the same as that of the study participants), 8 , 20 , 21 , 22 , 27 , 30 , 39 , 40 , 44 , 47 , 50 , 51 , 52 , 58 , 59 , 61 , 63 , 64 while others indicated their educational level or occupation. 8 , 15 , 18 , 19 , 20 , 22 , 24 , 25 , 27 , 29 , 30 , 32 , 33 , 37 , 39 , 40 , 43 , 47 , 49 , 57 , 61 , 62 The occupation of the navigators included health educators, 30 , 47 , 56 , 57 nurses, 15 , 18 , 19 , 23 , 29 , 30 , 37 , 41 , 42 , 45 lay persons, 20 , 27 , 43 , 51 , 62 specialist screening practitioners, 33 community health workers, 30 social workers 24 , 25 or community leaders. 60 Patient navigators had reached college, 28 , 29 , 30 , 39 , 40 , 61 , 64 obtained a master's degree 32 , 53 or bachelor's degree, 22 , 27 , 30 or were first year medical students. 49 Some studies reported their experience in community health outreach, 29 , 30 or telephone interventions. 32 , 53 One study used an interactive voice response (IVR) navigation. 54

Training of navigators was reported in 34 studies (79.1%), mainly indicating the duration of training. 20 , 21 , 22 , 24 , 25 , 27 , 28 , 29 , 30 , 39 , 43 , 44 , 47 , 49 , 53 , 60 , 62 , 63 The shorter trainings were for prevention care managers (half a day 21 ) and health centre outreach workers and interpreters (6 h). 39 For lay navigators, reported duration of training was 2 days 20 to 19 h plus a series of one‐on‐one structured role plays simulating a navigation encounter. 27 The maximum duration referred was 80 h for navigators with a bachelor's degree in public health or a related field 22 and in a study not specifying the navigator's background. 44 Studies with nurse navigators did not clarify the length of training.

Most studies reported ad hoc training programmes, with few referring an already existing programme from an institution or a standardized national programme providing a certification. 20 , 22 , 26 , 52 Twelve studies described the contents of training, 18 , 19 , 21 , 27 , 28 , 29 , 30 , 39 , 44 , 47 , 50 , 58 , 60 which included education on a selected cancer and its screening, 30 , 39 , 44 , 49 , 60 , 64 topics related to care (common patient barriers 28 and how to address them, 51 local community resources, 28 , 44 and appropriate follow up for abnormal results 60 ), navigator roles 28 , 60 and responsibilities, 27 , 28 skills in communication (motivational interviewing techniques, 18 , 19 , 20 , 30 , 39 , 42 , 46 , 64 interview protocols, 53 communication with clinicians 64 ), and monitoring and evaluation (data management, 28 , 44 , 49 , 64 quality measures 28 ). Seven studies reported the use of role‐playing as a learning strategy. 21 , 29 , 30 , 43 , 50 , 53 , 60 Three studies had continuing education sessions, 22 , 44 , 62 three included site visits to clinics 27 , 43 , 44 and one the attendance to a colonoscopy. 24 No study described training in confidentiality and privacy practices. The supervision of navigators was referred to in only 16 studies (36.4%), and when described the supervision was often achieved through regular meetings, 21 , 25 , 28 , 29 , 30 , 43 , 60 or auditing navigator telephone calls. 29 , 30 , 48 , 53

Apart from screening participation, studies monitored and evaluated a wide variety of indicators related to the navigation process, more specifically on communication, barriers reported, navigation services provided and time. With regards to communication, indicators used were the number of study participants contacted, 21 , 30 , 33 , 39 , 51 , 53 , 63 number of contacts 21 , 22 , 29 , 30 , 32 , 43 , 47 , 52 , 59 , 63 or duration of contact. 21 , 24 , 29 , 30 , 33 , 43 , 53 Few studies stated the number of attempts patient navigators made to reach participants, those that did range from up to 3 48 , 63 to up to 12 attempts. 21 In the main, studies did not report the average length of telephone calls, 21 , 24 , 43 , 46 with only two studies differentiating between initial and subsequent calls, 21 , 24 and two indicating the average total time spent with participants. 29 , 30

Studies described the most frequent barriers faced by study participants, 16 , 18 , 19 , 22 , 47 , 51 , 52 , 59 workload of navigators, 20 , 21 , 25 , 28 , 29 , 34 , 35 , 38 , 50 , 62 navigation services provided 25 , 39 , 52 , 61 , 62 and time spent by activity. 37 Several studies measured screening process or programme outcomes such as screen positivity 16 , 44 or number of cancer cases identified, 30 , 39 , 52 attendance to follow‐up, 33 predictors of participating in screening 8 , 26 , 27 , 31 , 49 , 60 and cost or cost‐effectiveness. 18 , 19 , 23 , 28 , 33 , 37 , 45 , 46 , 55 , 56 , 64 Few studies measured knowledge and perception of screening, 38 , 41 satisfaction with navigation services 62 or adverse events (after colonoscopy). 23 One study assessed training outcomes, such as knowledge of navigator, level of abilities or satisfaction with training. 60

Only 21 studies (47.7%) explicitly identified the theoretical framework used to inform the intervention. Most studies included behavioral frameworks, as the health belief model, 8 , 15 , 18 , 19 , 20 , 36 , 46 , 47 the transtheoretical model or stages of change model, 29 , 30 , 42 , 47 , 48 , 60 the theory of reasoned action 20 , 53 or the Precaution Adoption Process Model (PAPM), 32 , 34 , 35 , 38 the social cognitive theory. 8 , 15 , 16 , 18 , 19 , 20 , 36 , 44 , 46 , 53 , 59 , 62 and the Preventive Health Model (PHM). 34 , 35 , 38 Other studies employed planning/evaluation frameworks, as PRECEDE (Predisposing, Reinforcing and Enabling Constructs in Educational Diagnosis and Evaluation)/PROCEED (Policy, Regulatory and Organizational Constructs in Educational and Environmental Development) planning model, 8 , 53 CEDIP (Clarify, Empathize, Disclose, Inform and Plan)/CEEP (Clarify, Empathize, Educate and Plan) model. 27

The presence of components of patient navigation was quite similar across cancer sites. However, breast cancer screening studies reported more frequently training (n = 9, 100%) and addressing individual barriers (n = 6, 66.7%), while programmes for multiple cancer sites together were more likely to describe supervision (n = 3, 50%).

3.2. Effectiveness of patient navigation

Screening participation was reported based on medical record review in the majority of included studies, but some studies estimated participation based on self‐reporting only, 22 , 26 , 35 , 43 , 44 , 50 , 62 while three used a combination of both methods. 8 , 17 , 34 Screening participation was measured over a period ranging from 14 days 49 to 30 months. 46 Patient navigation increased screening participation for the three cancer sites regardless of the measure of socioeconomic measure considered (Table 2). It was compared with baseline/usual care, 8 , 20 , 21 , 24 , 25 , 27 , 28 , 29 , 30 , 31 , 33 , 39 , 40 , 41 , 42 , 43 , 47 , 48 , 54 , 55 , 56 , 57 , 58 , 61 , 62 , 64 enhanced usual care (frequently not described), 15 , 18 , 19 , 36 , 46 or other interventions, 15 , 16 , 17 , 18 , 19 , 22 , 26 , 31 , 43 , 44 , 45 , 46 , 49 , 50 , 53 , 56 , 57 , 58 , 59 , 63 these being mainly educational interventions. 15 , 18 , 19 , 22 , 26 , 44 , 45 , 46 , 49 , 50 , 59 , 63 The proportion of participants assigned to patient navigation receiving the intervention ranged from 10.5% 33 to 96.1%; 54 few studies provided this information.

TABLE 2.

Screening participation expressed as %, increase and/or odds ratio (OR), by cancer site.

First author, year Comparison Intervention Screening participation (intervention vs comparison(s)) (%) p value OR (95% CI), intervention vs comparison(s) p value
Colorectal cancer
Arnold, 2016 41

[1] enhanced version of usual care

[2] health literacy‐informed educational intervention

[1] and nurse providing a health literacy‐informed education and telephone follow‐up using motivational interviewing

47.4% vs 34.2% [1] vs 59.6% [2]

44.4% vs 39.1% [1] vs 76.9[2] in limited health literacy

52.2% vs 26.7 [1] vs 53.9% [2] in adequate health literacy

0.21 after adjusting for age, race, sex, and health literacy

0.007 in limited health literacy

0.002 with adequate health literacy

1.35 (0.78–2.33) compared to enhanced care

0.75 (0.49–1.17) compared to education

0.28

0.20

Braun, 2005 19 group education + small media + free FOBT + single telephone reminder call group education + experience from Native Hawaiian CRC survivor + educational material + free FOBT + reminder calls (which included efforts to address personal emotions and barriers) 8% increase vs 16% increase <0.05
Cole, 2017 33

[1] motivational interviewing for blood pressure control

[2]: [1] + patient navigation

[3] Patient navigation

17.5% [3] vs 8.4% [1] vs 17.8% [2]

Compared to [1]:

2.32 (1.55–3.46) unadjusted;

2.43 (1.32–4.46) adjusted for education, hypertension awareness, self‐reported diabetes and health literacy

Davis, 2013 43

Davis, 2014 44

[1] enhanced usual care

[2] educational strategy

[3]: [2]+nurse support

Initial FOBT:

60.6% [3] vs 57.1% [2]

Second FOBT:

59% vs 33% [2]

<0.001

0.017

Initial FOBT compared to [2]:

1.18 (0.97–1.42)

Second FOBT compared to [2]:

1.46 (1.14–1.86)

0.09

0.002

DeGroff, 2017 42 Usual care Patient navigation 61.1% vs 53.2% 0.021

1.51 (1.12–2.03)

2.60 (1.64–4.13) Hispanics vs non‐Hispanic whites

0.007

≤0.001

Dietrich, 2013 49 Usual care Prevention care management

36.7% vs 30.6% overall

32% vs 17.5% colonoscopy

14.7% vs 11.7% FOBT

1.32 (1.08–1.62) overall adjusted for age, comorbidities (diabetes, hypertension, and high cholesterol levels), visits within 18 months, insurance (Medicaid or Family Health Plus), and primary language, all at baseline

2.22 (1.62–3.05) colonoscopy

1.31 (0.87–1.95) FOBT

Enard, 2015 28 Mailing of educational materials Patient navigation

43.7 vs 32.1% overall

35.6 vs 23.8 colonoscopy/FS

0.04

0.03

1.64 (1.02–2.62)

1.82 (1.11–3.00) adjusted for age, gender, education, and usual source of care provider status.

Colonoscopy/FS: 1.77 (1.07–2.91)

1.90 (1.13–3.22) adjusted for age, gender, education, and usual source of care provider status

FOBT:

1.57 (0.87–2.81)

1.79 (0.96–3.33) adjusted for age, gender, education, and usual source of care provider status

0.04

0.02

0.03

0.02

0.13

0.07

Green, 2013 57

[1] Usual care

[2]: [1] + automated care

[3]: [2] + assisted care

[4]: [3] + navigated care

64.7% vs 57.5% [3] overall in both years

35.8% vs 30.5% [3] FOBT in both years

Guillaume, 2017 16

De Mil, 2018 17

Usual postal reminder Patient navigation

Screening population:

29 vs 27.5%

26.8 vs 25.6% (deprived strata)

24.2 vs 24.1 (urban deprived)

30 vs 27.2% (rural deprived)

31.6 vs 29.6% (affluent strata)

30.8 vs 30% (urban affluent)

32 vs 29.4% (rural affluent)

Navigable population:

24.3 vs 21.1%

22.8 vs 20.2% (deprived strata)

21.5 vs 18.9% (urban deprived)

24.3 vs 21.3% (rural deprived)

26.0 vs 21.9% (affluent strata)

25.4 vs 22.1% (urban affluent)

26.6 vs 21.8% (rural affluent)

0.35

0.53

0.95

0.3

0.42

0.85

0.29

0.003

0.07

0.15

0.16

0.01

0.07

0.02

Screening population:

1.08 (0.99–1.18)

1.27 (1.12–1.44) (rural deprived vs urban deprived)

1.41 (1.22–1.63) (urban affluent vs urban deprived)

1.39 (1.24–1.56) (rural affluent vs urban deprived)

Navigable population:

1.19 (1.10–1.29)

1.17 (1.05–1.31) (rural deprived vs urban deprived)

1.25 (1.11–1.41) (urban affluent vs urban deprived)

1.26 (1.13–1.40) (rural affluent vs urban deprived)

0.060

<0.001

<0.001

<0.001

Horne, 2015 30 Printed educational materials Patient navigation

94% vs 91%

Among participants not up to date at baseline: 72.5% vs 58.6%

0.04

0.008

1.56 (1.08–2.25)

Adequate health literacy compared to low health literacy: 1.11 (0.76–1.63)

70–74 years compared to 65–69 years:

0.98 (0.67–1.42)

0.02

0.57

0.90

Jandorf, 2013 23 [1] Standard of care: patient navigation

[2] Peer‐patient navigation

[3] Propatient navigation

74.0% [2] vs 76.4% [3] vs 80.4% [1] 0.648
Kim, 2018 35 No navigation Patient navigation 85.1 vs 73.4% <0.05
Lasser, 2009 48 Usual care Patient navigation

31.2 vs 8.9% overall

17.2 vs 7.8% FOBT

14.0 vs 1.1% colonoscopy

0.0002 overall
Lasser, 2011 47 Usual care Patient navigation

33.6 vs 20.0% overall

26.4 vs 13.0% colonoscopy

7.2 vs 6.5% FOBT

<0.001 overall

<0.001 colonoscopy

0.76

Levy, 2013 40

[1] Usual care

[2] physician chart reminder

[3] mailed education + FIT

[4]: [3]+patient navigation

57.2% [4] vs 56.5 [3] overall

19.3% [4] vs 22.0% [3] colonoscopy

<0.0001 overall

0.073 colonoscopy

Luckmann, 2013 24 Patient navigation

53.2% overall

68.1% colonoscopy

McGregor, 2019 62 Usual care Patient navigation 79.1 vs 79.8%
Myers, 2008 55 Tailored navigation 41%

Myers, 2013 58

Daskalakis, 2014 59

Lairson 2014 60

[1] Usual care

[2] Standard intervention (mailed materials and FOBT)

[3] Tailored navigation

38% [3] vs 12% [1] vs 33% [2] at 6 months

43% [3] vs 18% [1] vs 36% [2] at 12 months

0.001 for both comparisons with [1]

At 6 months:

4.60 (3.02–7.02) vs [1] adjusted

1.25 (0.89–1.75) vs [2] adjusted

At 12 months:

3.48 (2.39–5.07) vs [1]

1.30 (0.94–1.81) vs [2]

Navigation compared to no navigation:

2.09 (1.26–3.49)

0.001

0.201

0.001

0.118

0.005

Myers, 2014 25 Standard intervention (mailed materials and FOBT) Tailored navigation

At 6 months:

38.0% vs 23.7% overall

21.5 vs 15.3% FOBT

16.5 vs 8.4% colonoscopy

At 12 months:

43.5% vs 32.2% overall

23.0 vs 18.5% FOBT

20.4 vs 13.7% colonoscopy

2.1 (1.5–2.9)

1.7 (1.2–2.3)

0.001

0.001

Percac‐Lima, 2009 39

Percac‐Lima, 2014 26

Usual care Patient navigation

At 9 months:

27.4 vs 11.9% overall

20.8 vs 9.6% colonoscopy

At 5 years:

20.0 vs 11.1% overall

26.0% vs 15.2% among Latinos

26.3% vs 13.9% among non‐English speakers

0.001

0.001

0.001

Ruggeri, 2020 37 Baseline Care gap analysis

47.9% vs 23.2% highest increase in a clinic

43.3% vs 27.68% (average)

Temucin, 2020 61 Usual care Patient navigation

At 3 months:

81.8% vs 9.1% FOBT

14.5% vs 3.6% colonoscopy

At 6 months:

83.6% vs 10.9% FOBT

21.8% vs 3.6% colonoscopy

0.000

0.047

0.000

0.004

Walsh, 2010 56

[1] Usual care

[2] Mailed FOBT and information

[3]: [2] + tailored telephone counselling

25.1% vs 15.1% [2] FOBT

21.4% vs 11.9% [2] any screening test

0.001

0.001

Breast cancer
Burhansstipanov, 2010 21 4 newsletters Patient navigation 54.87% vs 1.5% <0.05

Davis, 2014 45

Davis, 2015 46

[1] enhanced usual care

[2] educational strategy

[3]: [2]+nurse support

At 6 months:

65.8% [3] vs 51.8% [2]

With limited literacy:

57.7% [3] vs 55.2% [2]

With adequate literacy:

74.3% [3] vs 50.4% [2]

At 24–30 months:

48.0% [3] vs 7.1% [2]

0.037

0.17

0.039

At 6 months, [2] reference:

1.37 (1.08–1.74)

At 24–30 months, [2] reference:

6.06 (3.63–10.12)

0.01

<0.001

Han, 2009 20 Baseline Patient navigation

83.5% vs 51.6% mammography

69.2% vs 46.2% CBE

<0.001

<0.001

Highfield, 2015 29 Standard appointment reminder Tailored counselling reminder

Basic analysis:

Unadjusted:

3.38 (1.59–7.21)

Adjusted:

3.88 (1.70–8.86)

Intention to treat analysis:

Unadjusted:

1.84 (1.01–3.35)

Adjusted:

2.31 (1.09–4.93)

<0.001

<0.001

<0.05

<0.05

Margulies, 2019 15 Informational pamphlets Volunteer run patient navigation

76% vs 42%

<0.05
Marshall, 2016 31 Printed education Printed education + patient navigation

93.3% vs 87.5%

73.4% vs 45.6% among women not screening‐adherent at baseline

<0.001

<0.001

2.26 (1.59–3.42)

Among women not screening‐adherent at baseline:

3.63 (2.10–6.26)

<0.001

significant

Molina, 2018 36 Standard care Patient navigation 51.4% vs 46.2% 0.04 Adjusted: 1.25 (1.02–1.54) 0.03
Phillips, 2011 22 Control Quality improvement patient navigation

87% vs 76% overall

85% vs 70% White

87% vs 78% African American

85% vs 83% Hispanic

88% vs 78% other

Adjusted:

2.5 (1.9–3.2) overall

Unadjusted:

2.4 (1.5–4.0) White

1.9 (1.4–2.6) African American

1.2 (0.8–1.8) Hispanic

2.1 (1.3–3.3) other

Taplin, 2000 51

[1] Postcard reminder

[2] Reminder call

[3]: Motivational call 49.8% vs 35.4% [1] vs 51.8% [2]
Cervical cancer
Corkrey, 2005 52 No intervention Interactive Voice Response (IVR) navigation
Hewett, 2016 63 [1] Standard model of service provision

[2] enhanced counselling

[3]: [2] + escort

21.3% [2] vs 24.6% [3] vs 4.2% [1] <0.001 ([1] vs [1, 2] vs [3])

[2] vs [1]:

2.76 (1.94–3.91)

[3] vs [1]:

2.98 (2.10–4.22)

<0.001

<0.001

Kitchener, 2016 53

Kitchener, 2018 54

[1] Control

[2] HPV self‐sampling test sent

[3] HPV self‐sampling test offered

[4] Timed appointment

[5] Choice of nurse navigation or HPV self‐sampling test

[6] Nurse navigation

At 12 months:

14.5% [6] vs 16.2% [1] vs 21.3% [2] vs 16.2% [3] vs 19.8% [4] vs 18.8% [5]

At 18 months:

22.8% [6] vs 27.1% [1] vs 30.0% [2] vs 25.8% [3] vs 29.0% [4] vs 30.2% [5]

[1] reference

At 12 months:

0.887 (0.670–1.174) [6]

1.091 (0.864–1.378) [5]

1.408 (1.141–1.738) [4]

1.074 (0.871–1.325) [3]

1.512 (1.197–1.910) [2]

At 18 months:

0.799 (0.642–0.994) [6]

1.058 (0.869–1.289) [5]

1.191 (0.975–1.456) [4]

1.056 (0.884–1.262) [3]

1.286 (1.056–1.567) [2]

0.401

0.466

0.001

0.505

0.001

0.044

0.573

0.087

0.548

0.012

Paskett, 2011 8 Usual care Patient navigation

51.1% vs 42.0% (medical records)

71.3% vs 54.2% (self‐report)

0.135

0.008

Medical records:

1.44 (0.89–2.33)

Self‐report:

2.10 (1.22–3.61)

0.135

0.008

Taylor, 2002 18

[1] Control

[2] Direct mail intervention

[3] Outreach worker intervention 39% [3] vs 15% [1] vs 25% [2]

<0.001 [3] vs [1], 0.03 [2] vs [1],

0.02 [3] vs [2]

3.5 (1.9–6.6) [3] vs [1] <0.001
Breast and cervical cancer
Falk, 2018 34 Education Education + patient navigation

Mammography:

2.64 (1.02–1.91)

Cytology:

2.72 (2.00–3.69)

<0.001

<0.001

Lee, 2011 64 Patient navigation 74.3%
Breast, cervical and colorectal cancer
Beach, 2007 50 Usual care Prevention care manager

Adjusted for patient characteristics and baseline up‐to‐date status:

Breast cancer: 1.86 (1.39–2.50) Spanish speaking

1.23 (0.85–1.78) English speaking

Cervical cancer:

2.18 (1.52–3.13) Spanish speaking

1.25 (0.81–1.91) English speaking

Colorectal cancer:

2.12 (1.54–2.90) Spanish speaking

1.62 (1.08–2.45)

English speaking

≤0.001

≤0.001

≤0.001

Braun, 2015 27 Control Patient navigation

61.7% vs 42.4% mammography

57.0% vs 36.4% cytology

43.0% vs 27.2% FS/colonoscopy

20.7% vs 12.6% FOBT

0.003

0.001

<0.001

0.02

Dietrich, 2007 38 Outreach programme Prevention care management

1.16 (0.86–1.57) breast cancer

1.18 (0.82/1.70) cervical cancer

1.69 (1.03–2.77) colorectal cancer

0.33

0.38

0.04

Percac‐Lima, 2016 32 Usual care Patient navigation

10.2% vs 6.8% all cancers combined

14.7% vs 11.0% breast cancer

11.1% vs 5.7% cervical cancer

7.6% vs 4.6% colorectal cancer

< 0.001

0.04

0.002

0.01

Overall, the comparison of patient navigation with usual care (21 studies) or other interventions (10 studies) favoured navigation. Compared to usual care, screening participation was 19.9% 21 to 250.6% 29 higher for colorectal cancer, 0.4% 54 to 160.0% 58 higher for cervical cancer, and 33.6% 64 to 45.5% 62 for breast cancer. Regarding the comparison to educational interventions, participation with patient navigation was 3.3% 26 to 36.1% 22 for colorectal cancer, and 6.6% 50 to 3558.0% 44 for breast cancer. However, there were a few exceptions: screening participation was lower in patient navigation groups in comparisons against a health‐literacy informed educational intervention in USA, 15 and against control and other interventions in UK. 56 , 57 Another study aimed to assess the impact of introducing patient navigation on social inequalities within the national organized screening programme in France. In this study navigation was found to be more effective in affluent than in deprived strata, entailing that if it was applied to the whole population, it has the potential to aggravate social inequalities in screening participation. 24 , 25

4. DISCUSSION

To the best of our knowledge, this is the first study to systematically describe the components of patient navigation programmes in breast, cervical and colorectal cancer screening using a specific framework of this intervention. In this systematic review we have identified studies on patient navigation as a single intervention and have described its impact on screening participation when compared against usual care and educational interventions.

Patient navigation increased participation to screening in breast, cervical and colorectal cancer in comparison with usual care and educational interventions alone, in line with the findings from previous publications, 6 , 8 , 65 suggesting patient navigation can improve the effectiveness and outcomes of screening programmes, and advance in health equity. 65 While many studies included in this review have overcome several previously described limitations (e.g., lack of control group or of randomization to treatment or comparison groups), 6 there remains an issue of not having a single definition of patient navigation, which in any case is rarely provided.

Moreover, another finding from this work is that studies describing patient navigation interventions could be better reported. Although the ‘who’ (nurse, social worker, lay person, etc.), ‘what’ (what barriers are addressed), ‘how’ (communication channel used) and ‘where’ (setting) aspects of intervention delivery were often described, the intensity of the intervention (number of interactions between navigator and individual, schedule and length) was rarely reported. 66 This lack of transparency also applied to the control intervention, frequently usual care. Such incompleteness of data hindered the possibility of conducting a meta‐analysis on the impact of patient navigation on breast, cervical and colorectal cancer screening participation, and its association with key components of patient navigation. Therefore, bearing in mind the great variation in the definition of patient navigation, we recommend a standardized reporting of its components that would allow comparison between studies, external validity, replication in different settings and ultimately a better measure of its impact on cancer screening participation. The better reporting of navigation programmes together with a consistent data collection would facilitate sustainability. 67

A positive finding was that over 84% of studies reported 9 or more components out of 14, being supervision and addressing of social and emotional barriers the least reported. As in a previous review, 68 the duration of training on patient navigation was quite diverse. We did not find a specific length reported to be adequate, as opposed to 3 days previously described for lay persons in cervical cancer screening. 69 Compared to a review conducted in the USA, 68 studies included in ours reported shorter duration of training (half a day vs 12 h). The maximum length of training could not be compared, as few studies reported if training was delivered over time or massed. 22 , 44 , 62 In any case, the length of training is generally linked to the background of trainees, and their expected roles and responsibilities. Another paper from the USA reported a consensus on the domains and competencies of the patient navigation training. 70 The topics described in the papers in our review included these competencies, but no study covered all.

The local context will determine the importance of each component to achieve a successful patient navigation programme. To plan patient navigation services, we need to know what the population eligible for the selected cancer screening requires through a needs assessment, as Ruggeri et al. did, 41 which will enable identifying which services it should include. 65 It is also possible to put in place a patient navigation programme and from its evaluation identify which are the most frequent barriers. Additionally, the least approached barriers were social and emotional, which are related to a lower screening participation 71 and could entail a delay in seeking medical help. 72 Moreover, although considered a requirement, 73 supervision of navigators was seldom described, being more frequently reported in programmes addressing multiple cancer sites screening, probably because of their complexity.

All studies included in this systematic review except one were conducted in high‐income countries. The implementation of patient navigation programmes has been scarcely reported outside USA, 74 including LMICs. A recent scoping review on this intervention in LMICs in cancer care focused mainly on tertiary level, with only one study on screening. The main services reported were facilitation of the linkage to follow‐up services, coordination of appointments and education to ensure understanding of symptoms and signs. Interestingly, few studies labelled their intervention as patient navigation. Studies evaluating navigation in cancer care reported mainly implementation science outcomes, such as the acceptability, fidelity and feasibility of the intervention, 75 rarely described in our included studies. Due to a high variability in health care systems across the world, there are limitations to applying the results from high‐income countries to LMICs. More research is needed in these settings to understand patient navigation in cancer screening with a global perspective.

Previous systematic reviews focused on USA and Canada only. 6 , 8 The inclusion of studies conducted in countries other than these two is one of the strengths of our systematic review. Other strengths are the search in three databases, including both medical and social databases, no language restriction and the use of a framework to assess the reporting of elements of patient navigation programmes.

The main limitation of this research is that the systematic search was not initially developed to assess patient navigation, as it included only “patient navigation” and “patient‐centred care” as search terms. However, when assessing the full texts, we were broad in the consideration of the term, as screening practitioners, prevention managers and care gap analysts have been included as navigators. Additionally, the inclusion of studies measuring self‐reported participation to screening may have overestimated the impact of navigation.

In conclusion, patient navigation is effective in increasing participation in breast, cervical and colorectal cancer screening, which can improve the effectiveness and outcomes of screening programmes. A standardized reporting of patient navigation and its components would allow its replication and a better measure of its impact. The local context and needs will determine the importance of each component and will enable the design of a successful patient navigation programme.

AUTHOR CONTRIBUTIONS

Isabel Mosquera: Conceptualization (equal); data curation (lead); formal analysis (equal); investigation (lead); methodology (equal); validation (lead); visualization (lead); writing – original draft (lead). Adam Todd: Conceptualization (equal); methodology (equal); supervision (equal); writing – review and editing (equal). Mirza Balaj: Conceptualization (equal); methodology (equal); writing – review and editing (equal). Li Zhang: Investigation (supporting); writing – review and editing (equal). Sara Benitez Majano: Data curation (supporting); investigation (supporting); writing – review and editing (equal). Keitly Mensah: Investigation (supporting); writing – review and editing (equal). Terje Andreas Eikemo: Funding acquisition (lead); writing – review and editing (equal). Partha Basu: Funding acquisition (supporting); writing – review and editing (equal). Andre L Carvalho: Conceptualization (equal); formal analysis (equal); investigation (lead); methodology (equal); supervision (equal); validation (supporting); writing – review and editing (equal).

CONFLICT OF INTEREST

The authors declare no conflicts of interest.

DISCLAIMER

Where authors are identified as personnel of the International Agency for Research on Cancer/World Health Organization, the authors alone are responsible for the views expressed in this article and they do not necessarily represent the decisions, policy or views of the International Agency for Research on Cancer/World Health Organization.

ACKNOWLEDGMENTS

This publication is supported by a grant awarded by the Norwegian Research Council (project number 288638) to the Center for Global Health Inequalities Research (CHAIN) at the Norwegian University for Science and Technology (NTNU).

APPENDIX 1. SEARCH STRATEGY USED IN WEB OF SCIENCE CORE COLLECTION

#1. TS = (breast) OR TS = (mammary)

#2. TS = (precancer* OR cancer* OR neoplas* OR tumor OR tumors OR tumour OR tumours OR carcinoma* OR adenocarcinoma* OR “adeno carcinoma*” OR adenoma* OR malignan* OR lesion*)

#3. #2 AND #1

#4. TS = (“cervical intraepithelial neoplas*” OR “uterine cervical neoplas*” OR “uterine cervical dysplas*” OR “atypical squamous cells of the cervix” OR “squamous intraepithelial lesions of the cervix”)

#5. TS = (“cervix uteri” OR cervical OR cervix OR cervixes OR cervices OR cervico*)

#6. TS = (precancer* OR cancer* OR neoplas* OR dysplas* OR dyskarios* OR tumor OR tumors OR tumour OR tumours OR carcinoma* OR adenocarcinoma* OR “adeno carcinoma*” OR adenoma* OR malignan* OR lesion* OR squamous OR “small cell” OR “large cell”)

#7. #6 AND #5

#8. #7 OR #4

#9. TS = (“colorectal neoplas*” OR “colonic neoplas*” OR “rectal neoplas*”)

#10. TS = (colon OR colonic OR bowel OR rectal OR rectum OR sigmoid OR anal OR anus)

#11. TS = (precancer* OR cancer* OR neoplas* OR dysplas* OR tumor OR tumors OR tumour OR tumours OR carcinoma* OR adenocarcinoma* OR “adeno carcinoma*” OR adenoma* OR malignan* OR lesion*)

#12. #11 AND #10

#13. #12 OR #9

#14. #13 OR #8 OR #3

#15. TS = (“socioeconomic factor*”) OR TS = (“educational status”) OR TS = (“educational level”) OR TS = (employment) OR TS = (occupation*) OR TS = (income) OR TS = (poverty) OR TS = (“social class*”)

#16. TS = (“socioeconomic inequalit*”) OR TS = (“socioeconomic inequit*”) OR TS = (“socioeconomic equalit*”) OR TS = (“socioeconomic equit*”) OR TS = (“health status disparit*”) OR TS = (“health disparit*”) OR TS = (“healthcare disparit*”) OR TS = (“health care disparit*”) OR TS = (“health inequalit*”) OR TS = (“health inequit*”) OR TS = (“health equalit*”) OR TS = (“health equit*”)

#17. TS = (“health literacy”) OR TS = (“depriv*”) OR TS = (gender) OR TS = (“minority group*”) OR TS = (“ethnic group*”) OR TS = (“vulnerable population*”) OR TS = (“disadvantaged population*”) OR TS = (“underserved population*”) OR TS = (“population group*”) OR TS = (“urban population*”) OR TS = (“suburban population*”) OR TS = (“rural population*”)

#18. TS = (awareness) OR TS = (access) OR TS = (barrier*) OR TS = (obstacle*) OR TS = (challenge*) OR TS = (gap) OR TS = (gaps) OR TS = (facilitator*) OR TS = (“patient acceptance of health care”) OR TS = (“patient acceptance of healthcare”) OR TS = (“patient dropout*”) OR TS = (“physician patient relation*”) OR TS = (“health knowledge”) OR TS = (attitude*) OR TS = (practice*) OR TS = (“persuasive communication”) OR TS = (“health behaviour*”) OR TS = (“health behavior*”)

#19. #18 OR #17 OR #16 OR #15

#20. TS = (“mass screening”) OR TS = (“population surveillance”) OR TS = (“screening and testing”) OR TS = (“early diagnosis”) OR TS = (“secondary prevention”) OR TS = (“early detection”)

#21. #20 AND #19 AND #14

#22. TS = (“cost shar*”) OR TS = (“reduced copay*”) OR TS = (“reduced cost*”) OR TS = (schedul*) OR TS = (transport*) OR TS = (“mobile health unit*”) OR TS = (“mobile unit*”) OR TS = (technolog*) OR TS = (“cell phone*”) OR TS = (“mobile phone*”) OR TS = (“text messag*”) OR TS = (“short message service”) OR TS = (sms) OR TS = (“communication barrier*”) OR TS = (“language barrier*”) OR TS = (“patient navigat*”) OR TS = (“patient centered care”) OR TS = (“patient‐centered care”) OR TS = (selfsampling) OR TS = (“self sampling”) OR TS = (choice)

#23. TS = (intervention*) OR TS = (implement*) OR TS = (action*) OR TS = (experiment*) OR TS = (“referral and consultation”)

#24. #23 OR #22

#25. TS = (“patient participation”) OR TS = (“community participation”) OR TS = (“stakeholder participation”) OR TS = (participat*) OR TS = (“patient compliance”) OR TS = (uptake) OR TS = (adherence) OR TS = (coverage)

#26. TS = (“voluntary program*”) OR TS = (voluntary) OR TS = (attendance) OR TS = (utilization) OR TS = (utilisation) OR TS = (“health promot*”) OR TS = (impact*) OR TS = (effect*) OR TS = (performance) OR TS = (“health care outcome assess*”) OR TS = (“healthcare outcome assess*”) OR TS = (examinat*) OR TS = (monitor*) OR TS = (“program* evaluat*”)

#27. #26 OR #25

#28. #27 AND #24 AND #21

#29. #27 AND #24 AND #21

Refined by: PY = (2000–2020)

APPENDIX 2. TABLE OF INCLUDED STUDIES BY CANCER SITE

The studies are provided in alphabetical order. However, when more than one paper describes a study, they have been placed consecutively.

First author, year Period of analyzed data Region, country Population/sample % women if applicable age Measure of socioeconomic position in inclusion criteria Measure of socioeconomic position in analysis Screening method evaluated Study design (number of arms) Quality assessment
Colorectal cancer
Arnold, 2016 41 May 2008–August 2011 Louisiana, USA

206 participants with negative FOBT in first and second round

80% women

50–85 years

Income, insurance Health literacy FOBT

Cluster RCT

(3 arms)

Poor
Braun, 2005 19 2002–2003 Hawaii, USA

121 Native Hawaiians

70% women in intervention and 75% in control

≥50 years

Ethnicity/race FOBT

RCT

(2 arms)

Poor
Cole, 2017 33 2010–2013 New York city, USA

731 self‐identified Black men

≥50 years

Ethnicity/race

Self‐reported FOBT or colonoscopy

RCT

(3 arms)

Good

Davis, 2013 43

Davis, 2014 44

May 2008 – August 2011 Louisiana, USA

961 patients

77% women

50–85 years

461 patients with negative initial FOBT

75% women

50–85 years

Geographic area (rural)

Literacy gFOBT

Quasi‐experimental

(3 arms)

Fair
DeGroff, 2017 42 September 2012–December 2014 Massachusetts, USA

843 adults (429 in intervention and 427 in control)

57.1% women

50–75 years

Income, ethnicity/race Colonoscopy

RCT

(2 arms)

Fair
Dietrich, 2013 49 December 2008 – July 2010 New York, USA

2240 women (562 in intervention and 1678 in control)

50–63 years

Primary language FOBT, colonoscopy, sigmoidoscopy, or barium enema

RCT

(2 arms)

Fair
Enard, 2015 28 March 2007–December 2010 USA

2084 Latino Medicare fee‐for service (FFS) enrollees (1044 in intervention and 1040 in comparison)

≥40 years

54.8% women in final analysis

Ethnicity/race Self‐reported FOBT, colonoscopy or sigmoidoscopy

RCT

(2 arms)

Poor
Green, 2013 57 August 2008 – November 2009 Washington, USA

4675 adults (653 in arm 1, 629 in arm 2, 615 in arm 3 and 647 in arm 4)

50–73 years

FOBT, colonoscopy, sigmoidoscopy Cluster RCT Good

Guillaume, 2017 16

De Mil, 2018 17

April 2011–April 2013 3 departments in France

14,373 subjects in the intervention group and 14,556 control subjects 50–74 years

Material deprivation, rural/urban Material deprivation, rural/urban FOBT

Cluster RCT

(2 arms)

Poor
Horne, 2015 30 April 2006 – June 2010 Baltimore city, USA

1220 African Americans

72.8% women in intervention, 72.3% in control

65–75 years

Ethnicity/race Health literacy Colonoscopy/sigmoidoscopy, FOBT

RCT

(2 arms)

Poor
Jandorf, 2013 23 May 2008 – September 2011 USA

532 African Americans

> 50 years

Ethnicity/race Colonoscopy

RCT

(3 arms)

Poor
Kim, 2018 35 August 2016–April 2017 Chicago, USA

536 individuals in intervention and 2713 in control

Approx. 60% women in both arms

50–75 years

Ethnicity/race Colonoscopy

Cost‐effectiveness study, controlled trial

(2 arms)

Poor
Lasser, 2009 48 October 2007 Massachusetts, USA

55 patients

63.4% women in intervention, 75.6% in control

52–80 years

Primary language FOBT, colonoscopy, sigmoidoscopy or barium enema

RCT

(2 arms)

Poor
Lasser, 2011 47 September 2008 – March 2010 Massachusetts, USA

465 primary care patients (235 in intervention −60.4% women, 230 in control −62.6% women)

52–74 years

Primary language Age, ethnicity/race, primary language, health insurance coverage FOBT, colonoscopy, sigmoidoscopy or barium enema

RCT

(2 arms)

Good
Levy, 2013 40 December 2008–April 2011 Iowa, USA

743 primary care patients (185 in usual care, 185 in physician chart reminder, 186 in mailed education/FIT, 187 in patient navigation) aged

50.8–53.5% women in each arm

52 to 79 years

Geographic area (rural), income FIT, colonoscopy

RCT

(4 arms)

Fair
Luckmann, 2013 24 February 2006–May 2007 Massachusetts, USA

362 primary care patients

63% women

50–79 years

Ethnicity/race, socioeconomic status, geographic area (urban, rural)

FOBT, colonoscopy,

sigmoidoscopy, barium enema or virtual colonoscopy

After only (1 arm) Poor
McGregor, 2019 62 Recruitment: May–October 2015 Tyne and Wear, England, UK 152 not confirming or attending appointment (109 in intervention −53.2%‐, 43 in control −53.5%) Flexible sigmoidoscopy

RCT

(2 arms)

Poor
Myers, 2008 55 Delaware, USA

154 primary care practice patients

57% women

≥50 years

FOBT, colonoscopy, sigmoidoscopy or barium enema

After only study

(1 arm)

Fair

Myers, 2013 58

Daskalakis, 2014 59

Lairson, 2014 60

2007–2011 Delaware, USA

945 primary care patients

66% women in tailored navigation intervention (n = 312), 64% in standard intervention (n = 316) and 57% in control (n = 317)

50–79 years

Self‐reported FOBT, colonoscopy, sigmoidoscopy or barium enema

RCT

(3 arms)

Fair
Myers, 2014 25 December 2008–October 2011 (identification of patients) Philadelphia, USA

764 African Americans (384 in intervention and 380 in control)

72.7% women in intervention and 64.1 in control

50–75 years

Ethnicity/race FOBT, colonoscopy, sigmoidoscopy or barium enema

RCT

(2 arms)

Fair

Percac‐Lima, 2009 39

Percac‐Lima, 2014 26

January–October 2007

2006–2010

USA

1223 patients (409 in intervention and 814 in control)

60% women

52–79 years

3115 patients in one practice and 43,905 patients in the other practices of the same network

Income, primary language

Income, ethnicity/race

Primary language

FOBT, colonoscopy, sigmoidoscopy or barium enema

RCT

(2 arms)

Controlled trial

(2 arms)

Fair

Ruggeri, 2020 37 2016–2018 USA

452 clinic patients

50–75 years

Ethnicity/race, insurance FIT Before‐after Poor
Temucin, 2020 61 Istanbul, Turkey

110 individuals (55 in intervention and 55 in control) registered at family health centres

50–70 years

65.5% women

FOBT, colonoscopy

RCT

(2 arms)

Good
Walsh, 2010 56 Baseline survey: 2005–2006, follow‐up survey: 2006–2007 California, USA

1358 individuals

69.7% women in patient navigation, 69.0% in intervention and 69.1% in control

50–79 years

Ethnicity/race Ethnicity/race Self‐reported FOBT, colonoscopy, sigmoidoscopy

RCT

(3 arms)

Poor
Breast cancer
Burhansstipanov, 2010 21 (5 years: training of navigators started in 2001; study ongoing in 2005) Denver, USA

313 women (113 in intervention and 200 in control)

40–85 years

Ethnicity/race, income Mammography

RCT

(2 arms)

Poor

Davis, 2014 45

Davis, 2015 46

May 2008 – August 2011 Louisiana, USA

1181 patients (323 in enhanced care, 355 in education, 503 in nurse support)

≥40 years

624 patients with negative initial mammography (172 in enhanced care, 154 in education, 298 in nurse support)

≥40 years

Geographic area (rural) Literacy Mammography

Cluster RCT

(3 arms)

Poor
Han, 2009 20 USA

100 Korean American women

40–80 years

Ethnicity/race Mammography, CBE After only (1 arm) Poor
Highfield, 2015 29 February – December 2012 Houston area, USA

151 African American women

36–64 years

Ethnicity/race, income, insurance Mammography

Initially RCT and after quasi experimental

Type I hybrid design

(2 arms)

Poor
Margulies, 2019 15 3 weeks after September 2015 USA

49 women (25 in intervention and 24 in control)

40–76 years

Income Employment Mammography

RCT

(2 arms)

Fair
Marshall, 2016 31 April 2006–December 2010 Baltimore, USA

1905 African American Medicare beneficiaries

≥ 65 years

Ethnicity/race Health literacy Mammography RCT Poor
Molina, 2018 36 2011–2014 initial study Chicago, USA

2536 women with access to primary care (741 in intervention and 1795 in control)

50–74 years

Income, ethnicity/race Mammography

RCT

(2 arms)

Fair
Phillips, 2011 22 February–November 2008 USA

3895 women in hospital‐based primary care practice (1817 in intervention and 2078 in control)

51–70 years

Ethnicity/race, income Ethnicity/race, insurance, education Mammography

Cluster RCT

(2 arms)

Poor
Taplin, 2000 51 Seattle, USA

1765 women

50–79 years

Mammography Randomized trial Fair
Cervical cancer
Corkrey, 2005 52 April–July 2001 New South Wales, Australia 18–69 years Cytology

RCT

(2 arms)

Poor
Hewett, 2016 63 2013 Lusaka and Chipata districts, Zambia

2043 women (678 in arm 1, 685 in arm 2, 680 in arm 3)

≥18 years

RCT

(3 arms)

Fair

Kitchener, 2016 53

Kitchener, 2018 54

April 2013 – November 2014 (phase II) Greater Manchester and Grampian, UK

10,126 women non‐attenders in phase I of study (1007 in nurse navigation, 1277 in choice between nurse navigation and HPV self‐sampling)

25 years

HPV self‐sampling, cytology

Cluster RCT

(6 arms)

Fair
Paskett, 2011 8 May 2005 – February 2009 Ohio, USA

280 women (143 in intervention and 137 in control)

≥ 18 years

Geographic area Cytology

RCT

(2 arms)

Poor
Taylor, 2002 18 1999 Seattle, USA, and Vancouver, Canada

482 Chinese women

20–69 years

Ethnicity/race Cytology RCT Poor
Breast and cervical cancer
Falk, 2018 34 March 2012 – February 2015 Rural and Border Texas, USA

2689 women self‐identified as African American, Latina or non‐Hispanic white

18–99 years

Geographic area, income, insurance Ethnicity/race, primary language Mammography, cytology

Controlled trial

(2 arms)

Poor
Lee, 2011 64 September 2008 – October 2009 Chuncheon city, South Korea

210 women

>40 years

Before‐after

(1 arm)

Fair
Breast, cervical and colorectal cancer
Beach, 2007 50 November 2001–April 2004 USA

1346 women

50–69 years

Language preference Language preference Mammography, cytology, and flexible sigmoidoscopy/colonoscopy

RCT

(2 arms)

Fair
Braun, 2015 27 2006–2009 Hawaii, USA

488 Asian and Pacific Islander Medicare beneficiaries (242 in intervention and 246 in control)

Approx. 53% female

Ethnicity/race Mammography, cytology, and flexible sigmoidoscopy/colonoscopy

RCT

(2 arms)

Poor
Dietrich, 2007 38 May – December 2005 New York city, USA

1316 women (663 in intervention and 653 in control) not up to date with at least on cancer screening

40–69 years

Income mammography, cytology, FOBT, sigmoidoscopy, double contrast barium enema, colonoscopy

Cluster RCT

(2 arms)

Poor
Percac‐Lima, 2016 32 April – December 2014 USA

1612 individuals overdue for at least one screening (792 in intervention and 820 in control)

60.5% women in intervention and in control

21–64 years (breast and cervical cancer)

50–75 years (colorectal cancer)

Ethnicity/race, primary language, insurance Mammogram, breast magnetic resonance imaging, cytology, HPV testing, colonoscopy, sigmoidoscopy, barium enema, colonography

RCT

(2 arms)

Fair

Abbreviations: CBE, clinical breast examination; FIT, fecal immunochemical test; FOBT, fecal occult blood test; gFOBT, guaiac FOBT; RCT, randomized controlled trial.

APPENDIX 3. COMPONENTS OF PATIENT NAVIGATION PROGRAMMES DESCRIBED IN THE INCLUDED STUDIES, OVERALL AND BY CANCER SITE

Components of patient navigation programme Overall N (%) Colorectal cancer N (%) Breast cancer N (%) Cervical cancer N (%) Multiple cancer sites N (%)
Programme goals 44 (100) 24 (100) 9 (100) 5 (100) 6 (100)
Community characteristics 44 (100) 24 (100) 9 (100) 5 (100) 6 (100)
Point of intervention 44 (100) 24 (100) 9 (100) 5 (100) 6 (100)
Setting 43 (97.7) 24 (100) 9 (100) 4 (80) 6 (100)
Monitoring and evaluation (other than screening participation) 43 (97.7) 23 (95.8) 9 (100) 5 (100) 6 (100)
Communication 42 (95.5) 23 (95.8) 9 (100) 5 (100) 5 (83.3)
Background and qualifications 35 (81.4) a 18 (75) 8 (88.9) 3 (75) a 6 (100)
Training 34 (79.1) a 18 (75) 9 (100) 3 (75) a 4 (66.7)
Address educational barriers 28 (63.6) 16 (66.7) 6 (66.7) 2 (40) 4 (66.7)
Address health system barriers 27 (61.4) 15 (62.5) 6 (66.7) 2 (40) 4 (66.7)
Theoretical framework 21 (47.7) 12 (50) 5 (55.6) 1 (20) 3 (50.0)
Address individual barriers 21 (47.7) 10 (41.7) 6 (66.7) 3 (60) 2 (33.3)
Supervision 16 (36.4) 9 (37.5) 3 (33.3) 1 (20) 3 (50.0)
Address social and emotional barriers 11 (25.0) 5 (20.8) 2 (22.2) 2 (40) 2 (33.3)
a

Excludes one study where this component was not applicable.

APPENDIX 4. COMPONENTS OF PATIENT NAVIGATION PROGRAMMES IN THE INCLUDED STUDIES BY CANCER SITE

First author, year Theor. framework Progr. goals Community character. Point of interv. Setting Address health system barriers Address individual barriers Address educational barriers Address social and emotional barriers Commun. method Navigator background and qualification Training Supervision Monitoring and evaluation (other than screening participation)
Colorectal cancer
Arnold, 2016 41
Braun, 2005 19
Cole, 2017 33

Davis, 2013 43

Davis, 2014 44

DeGroff, 2017 42
Dietrich, 2013 49
Enard, 2015 28
Green, 2013 57

Guillaume, 2017 16

De Mil, 2018 17

Horne, 2015 30
Jandorf, 2013 23
Kim, 2018 35
Lasser, 2009 48
Lasser, 2011 47
Levy, 2013 40
Luckmann, 2013 24
McGregor, 2019 62
Myers, 2008 55

Myers, 2013 58

Daskalakis, 2014 59

Lairson, 2014 60

Myers, 2014 25

Percac‐Lima, 2009 39

Percac‐Lima, 2014 26

Ruggeri, 2020 37
Temucin, 2020 61
Walsh, 2010 56
Breast cancer
Burhansstipanov, 2010 21

Davis, 2014 45

Davis, 2015 46

Han, 2009 20
Highfield, 2015 29
Margulies, 2019 15
Marshall, 2016 31
Molina, 2018 36
Phillips, 2011 22
Taplin, 2000 51
Cervical cancer
Corkrey, 2005 52 NA NA
Hewett, 2016 63

Kitchener, 2016 53

Kitchener, 2018 54

Paskett, 2011 8
Taylor, 2002 18
Breast and cervical cancer
Falk, 2018 34
Lee, 2011 64
Breast, cervical and colorectal cancer
Beach, 2007 50
Braun, 2015 27
Dietrich, 2007 38
Percac‐Lima, 2016 32

Abbreviations: Character., characteristics; commun., communication; interv., intervention; NA, not applicable; progr., programme, theor., theoretical.

Mosquera I, Todd A, Balaj M, et al. Components and effectiveness of patient navigation programmes to increase participation to breast, cervical and colorectal cancer screening: A systematic review. Cancer Med. 2023;12:14584‐14612. doi: 10.1002/cam4.6050

DATA AVAILABILITY STATEMENT

The datasets generated and/or analyzed during the current study are included within the article and the supplementary information.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

The datasets generated and/or analyzed during the current study are included within the article and the supplementary information.


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