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The Cochrane Database of Systematic Reviews logoLink to The Cochrane Database of Systematic Reviews
. 2016 Oct 13;2016(10):CD012387. doi: 10.1002/14651858.CD012387

Systematic screening and assessment of psychosocial well‐being and care needs of people with cancer

Bojoura Schouten 1,✉, Geertruida E Bekkering 2,3, Patrick Vankrunkelsven 2,3, Jeroen Mebis 4,5, Elke Van Hoof 4, Johan Hellings 1,6, Ann Van Hecke 7
PMCID: PMC6457966

Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

  • To assess the effectiveness of screening and assessment of psychosocial well‐being and care needs on the well‐being of people with cancer.

  • To explore the intervention characteristics of these screening and assessment interventions (interventionists, instruments, procedures, implementation conditions).

Background

Description of the condition

Cancer is one of the leading causes of mortality and morbidity worldwide. According to the latest global statistics, there were 14.1 million new cancer cases in 2012 and this number is expected to increase to 24 million by 2035 (Ferlay 2015). Cancer accounted for 8.2 million deaths in 2012. With the increase of more successful therapeutic approaches, life expectancy of cancer patients is increasing, resulting in a growing population of cancer patients and survivors. In 2012, there were 32.6 million people living with cancer (within five years of diagnosis) worldwide.

Cancer and related treatments have a bio‐psychosocial impact on patients’ health and well‐being. Cancer patients may experience physical consequences such as pain, hair loss, nausea, weight gain/loss, fatigue, and sleeping difficulties varying from short to long term in nature (Carlson 2013; Feyer 2008; Heins 2013). Their psychosocial health is put to the test by emotional distress, fear of recurrence, memory changes, worries about the well‐being of relatives, sexual problems, social issues, employment and financial difficulties, often resulting in supportive care needs (Boyes 2012; Browne 2011; Knobf 2012; Mikkelsen 2008; Parry 2012).

The term ‘Psychosocial well‐being’ is used in this review as an umbrella term comprising the experience of psychological, emotional, cognitive, spiritual, existential, relational, familial and social role functioning of a person. In clinical practice and research, the psychosocial well‐being of patients, or the disruption of it, is measured on the basis of these components and with the degree to which supportive care needs are experienced. It is often also conceptualised and measured as a whole in terms of ‘Quality of Life’ (QoL) (Moons 2006), ‘Health‐Related Quality of Life’ (HRQoL) (Aaronson 1993; Ganz 1992), or ‘distress’ (NCCN 1999). The resulting ‘care needs’ can be defined as “the requirement of some action or resource in care that is necessary, desirable, or useful to attain optimal well‐being” for the person (Sanson‐Fisher 2000).

Depending on the studies and participating populations, the prevalence of distress within cancer patients varies from 35% to 55% (Carlson 2013). The experienced distress can result in supportive care needs with a high individual variability for all life domains, ranging from 1% to 93% patients who desire extra support (Harrison 2009). Thus cancer patients who experience high levels of distress or psychosocial burden do not necessarily desire extra supportive care. We believe, this is an important finding that indicates the need of a quality cancer care that is organised and driven by patient‐centered initiatives in order to spend the limited healthcare budgets as efficiently as possible.

In order to address the bio‐psychosocial impact on patients’ well‐being, cancer care should be comprehensive, as well as integrating psychosocial concerns in follow‐up (IOM 2008; Wolff 2015). The Institute of Medicine (IOM) stated that care should be patient‐centred, respectful of, and responsive to, patients’ experiences, needs, preferences and values, and that patients’ input on these should guide all clinical decisions (IOM 2001). National cancer plans were launched to integrate the psychosocial approach in cancer care (Grassi 2012), and routine screening of distress and needs is recommended as good practice across international cancer systems and in guidelines (Accreditation Canada 2008; Breitbart 2015; Holland 2011; IOM 2008; Meyer 2015; NBCC 2003; NCCN 2007).

Description of the intervention

In this review, the intervention of interest is recommended screening and assessment of psychosocial well‐being and care needs in cancer patients. A literature search shows wide variation in screening terms and definitions, as well as in the scope of the used instruments, the timing of assessment and the participants (Carlson 2003; Carlson 2012; Meijer 2013). We define screening of psychosocial well‐being as a concise measurement of psychosocial well‐being using a patient‐reported outcome measure (PROM), or a structured interview. An assessment is seen as a more extended or profound form of screening, and usually follows a positive screen in a so called ‘stepped screening approach’. Such screening interventions are usually contained in a specific care approach or in the care model that is used.

How the intervention might work

Screening for distress and supportive care needs in cancer care is primarily recommended to integrate the psychosocial topic in daily routine to achieve ‘cancer care for the whole patient’ (IOM 2008). This screening and assessment of psychosocial well‐being and care needs can stimulate (1) detection of, (2) communication on, and (3) tailored referral for psychosocial concerns (Bauwens 2014; Heyn 2013; Ristevski 2015), increasing the chance that patients with psychosocial difficulties receive the appropriate treatment to support them. If the application of interventions for screening and assessment of patients’ psychosocial well‐being and care needs contributes to a more efficient and effective healthcare delivery, it is expected that it consequently can improve cancer patients’ well‐being (Whitney 2014; Zabora 2012). Likewise, actively querying patients’ experiences and needs could stimulate patients to fulfil a more active role in their own care trajectory (Cox 2006). This induces the patient‐centredness that is needed to create a good match between patients’ care needs and the delivered care. Comprehensiveness, efficiency, and patient‐centredness are essential components in achieving high‐quality cancer care (Hess 2013; Zucca 2014).

Why it is important to do this review

Several Cochrane systematic reviews focus on the effect of psychological and psychosocial interventions for cancer patients (Galway 2012; Goedendorp 2009; Parahoo 2013; Semple 2013). However, results are inconclusive. A significant variation in participants, mode of intervention delivery, discipline of the involved care professionals and intervention content is observed (Galway 2012; Semple 2013). To respond to these findings, we chose to focus on a specific type of psychosocial intervention, namely the screening and assessment of patients’ psychosocial well‐being and care needs. It is expected these interventions bring an added value to the organisation of health care, and have a positive impact on the well‐being of patients. This type of screening in cancer care is widely recommended. However, this is often based on consensus of professionals and policy makers. The existence of evidence‐based data, collected in earlier reviews, seems to be scarce and is quite often contradictory (Bidstrup 2011; Carlson 2012; Meijer 2013).

Thus, the question remains whether systematic screening and assessment of psychosocial well‐being and care needs in cancer care have a positive effect on cancer patients’ well‐being. We are aware that there are many factors that contribute to the psychosocial well‐being of cancer patients. We believe, both patients’ socio‐demographic and medical characteristics, as well as the characteristics of the care interventions may play an important role. Therefore, we would like to explore the characteristics of psychosocial screening and assessment interventions that are implemented in international practice and research. This could provide insight in the extent to which differences in these characteristics may contribute to the effect that screening interventions have on the psychosocial well‐being and care needs of the target audience. Examples of aspects that are likely to determine whether screening makes a difference: the level of training of involved healthcare professionals; the stakeholder that administers the screen; to whom the screening results are communicated; the protocols and care interventions that exist to respond to the screening results.

Consequently, we plan to address the following two research questions in this systematic review.

  • What is the effect of screening and assessment of psychosocial well‐being and care needs on the well‐being of people with cancer?

  • What are the intervention characteristics in screening and assessment of cancer patients’ psychosocial well‐being and care needs?

We expect this systematic review to add value compared to earlier reviews on this topic and related topics. Firstly, we will rely on a more extensive collection of sources for the search of studies. We will search in five databases, in five trial registers, in the tables of contents of two highly relevant journals, in conference abstracts of the World Congress on Psycho‐Oncology, and reference lists of all included records as well as reference lists of relevant reviews or guideline papers will be screened. Secondly, we will include randomised clinical trials (RCTs) as well as non‐randomised controlled trials (NRCTs). RCT designs are seen as the most reliable and bias‐resistant research designs, and previous reviews have focused on this type of study design. However, the nature of the clinical field and interventions make it hard to only evaluate evidence with RCTs Sidani 2015. This is why we will explore evidence from RCTs as well as NRCTs in this systematic review allowing the principle of extrnal validity to be taken into account. Thirdly, we will focus on the wide range of outcomes that is used in research to operationalise patients’ psychosocial well‐being. Fourthly, we will not only focus on the final effect of the specific psychosocial screening and assessment interventions. Like Ranchor and colleagues.(Ranchor 2012), we intend to describe the specific characteristics and components of these interventions (e.g. the instruments used, the procedures undertaken, the conditions set, as well as the care professionals that are involved in the intervention). Fifthly, calls for screening intervention research (Carlson 2012) and study protocol papers (Singer 2014) suggest that there will be new evidence‐based data.

This systematic review will provide a complete summary of international studies on this topic, relevant for research, policy and practice. Shortcomings in research will be identified and will provide information for future research into the composition of, or conditions for effective screening and assessment of psychosocial well‐being and care needs. Policy makers can be provided with comprehensive evidence‐based data to support recommendations and guidelines. Likewise, the findings of studies in this review could clarify the effects or value of psychosocial screening and assessment for clinical practice, and provide information on crucial components and characteristics for successful implementation in daily routine practices.

Objectives

  • To assess the effectiveness of screening and assessment of psychosocial well‐being and care needs on the well‐being of people with cancer.

  • To explore the intervention characteristics of these screening and assessment interventions (interventionists, instruments, procedures, implementation conditions).

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs) are the golden standard to evaluate intervention effects. However, RCTs are often not available to address questions about the effects of health system interventions and implementation strategies, due to the nature of the field (Sidani 2015). Consequently, we will include non‐randomised controlled trials (NRCTs), such as controlled before‐after studies (CBAs), interrupted‐time‐series studies (ITS), repeated measures studies (RMS) and historically‐controlled studies (HCTs).

  • In CBAs. observations are made before and after the implementation of an intervention, both in a group that receives the intervention and in a control group that does not.

  • In ITS one uses observations at multiple time points before and after an intervention (the ‘interruption’). The design attempts to detect whether the intervention has had an effect significantly greater than any underlying trend over time.

  • RMS are ITS studies where measurements are made in the same individuals at several time points.

  • In HCTs a group of participants receiving an intervention is compared with a similar group from the past who did not.

In the data analysis we will take into account whether study designs were randomised or not, and subgroup analysis will be used to see if conclusions from research with randomised and non‐randomised designs are comparable.

Types of participants

Adult cancer patients, at any time point of their care trajectory (at diagnosis, in active treatment, at completion of treatment, in follow‐up or survivorship). We will exclude research literature specifically on children, teenagers and adolescents. The minimum age will be 18. References will be excluded when the study authors appoint their study population specifically with the term ‘children’, 'teenagers', 'adolescents', or related terms.

Intuitively we think the psychosocial context and roles of older adults differ from that of younger adults who are still at an age expected to be at work, contributing to the economy, or raising children. Consequently, the impact of the cancer diagnosis and treatment on these patients well‐being can differ. We will include all adults, investigate heterogeneity and perform subgroup analysis to distinguish between the different age groups if study authors appoint their study population specifically with the term ‘young adults’, 'middle‐aged adults', 'elderly', or related terms.

Types of interventions

In this review, the intervention of interest is the screening and assessment of psychosocial well‐being and care needs in cancer patients. The term ‘psychosocial’ screening and assessment in this review should be interpreted in terms of screening and assessment of psychosocial, psychological, emotional or social well‐being, quality of life, distress, anxiety or depression, or supportive care needs.

We expect to find studies that focus on the evaluation of rather solitary or simple screening interventions, and to find studies with screening or assessment interventions that are part of a larger and more complex intervention. In the case of the simple screening interventions for example, we could find 'distress screenings' that patients themselves need to complete on a touch‐screen computer in the waiting room, and afterwards the screening results are freely available for the healthcare professionals who want to use them, without further guidelines on the use of this screening results. In the case of screening and assessment interventions that are included in a larger or more complex intervention (care pathway or care program), we expect that there are more concrete conditions and actions defined and described in the interventional procedure to be linked to the actual or simple screening intervention. There may be training sessions for the involved healthcare professionals on the conduction of the screening intervention or interpretations and use of screening results, guidelines that specify the discussion and management of screening results, and the procedures in order to move on to referral or follow‐up care directed at the detected concerns or care needs. Consequently, there is variety in the intervention characteristics, and there is no single universal model of psychosocial screening and assessment intervention that can be studied. However, the data collection for this review will provide an overview of these differences and their potential influence on the effect that these screening and assessment interventions have on patients’ well‐being.

The studies of interest must at least compare a psychosocial screening or assessment condition with a standard care condition. Under standard care we will consider the condition which is described by the study authors as ‘standard care’ or ‘usual care', and does not contain any form of screening or assessment of psychosocial well‐being and care needs. Possibly, the research design will contain more than two comparative conditions (e.g. standard care ‐ care with a simple screening intervention ‐ care with a more complex screening intervention).

Interventions that report only combined outcomes after screening plus more complex interventions (e.g. therapy, coaching, full care pathways or care programs) will be excluded.

Types of outcome measures

Outcomes should be collected with self‐report questionnaires and potentially through interviews which use patient‐reported outcome measures (PROMs) for guidance and outcome registration.

Primary outcomes

Cancer patients’ psychosocial well‐being and care needs measured in terms of:

  • QoL: e.g. measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC‐QLQ‐C30) (Aaronson 1993);

  • HRQoL: e.g. measured with the Short Form (36) Health Survey (SF‐36) (Aaronson 1998);

  • distress: e.g. measured with the Hospital Anxiety and Depression Scale (HADS) (Zigmond 1983); the Beck Depression Inventory (BDI) (Beck 1996); the Distress Thermometer (DT) (Tuinman 2008);

  • supportive care needs: e.g. measured with the Supportive Care Needs Survey (SCNS) (Sanson‐Fisher 2000) and the Cancer Survivors' Unmet Needs measure (CaSUN) (Hodgkinson 2007).

Secondary outcomes

  • Psychosocial well‐being measured by contributing components, defined by study authors as follows: cognitive, emotional, psychological, social or spiritual well‐being; mental health; and symptoms of anxiety or depression’.

  • Patients’ satisfaction: positive experiences with care contribute to the well‐being of patients; this is why patient satisfaction is often explored to evaluate interventions and quality of care (Lis 2009). Examples of PROM for this outcome are the EORTC cancer in‐patient satisfaction with care measure (EORTC IN‐PATSAT32) (Bredart 2004; Bredart 2005), and the Patient Satisfaction and Quality in Oncological Care (PASQOC) (Kleeberg 2005; Kleeberg 2008).

  • Adverse events: overburdening of patients by screening procedures; or induced fear or stress by discussing potential concerns and care needs with patients who normally might prefer to use an avoidance‐coping strategy.

Search methods for identification of studies

To identify records for inclusion in this systematic review, we will use several resources. We will included records in English, French and Dutch. Publication status will not be an exclusion criteria and we will map multiple records to individual studies.

Electronic searches

The following databases will be searched:

  • The Cochrane Central Register of Controlled Trials (CENTRAL); current issue

  • MEDLINE (through Ovid) to date

  • PsycINFO (through Ovid) to date

  • Embase (through Ovid) to date

  • CINAHL (through EBSCO) to date

The search strategy consists of a combination of controlled vocabulary and free text terms for ‘cancer’, ‘care model’, ‘psychosocial’, ‘screening’ and ‘assessment’. The initial search strategy was developed for MEDLINE (Appendix 1), and will be subsequently adjusted for the other databases.

Searching other resources

Reference lists

We will screen reference lists of all included records, as well as reference lists of relevant reviews or clinical guidelines for relevant records.

Focused literature search

We will search the tables of contents of the last five years (2010 to 2015) in the journals Psycho‐Oncology and Supportive Care in Cancer.

Trial registers

We will also search the following trial registers in an attempt to identify unpublished screening studies: https://clinicaltrials.gov, the National Research Register http://webarchive.nationalarchives.gov.uk; the ISRCTN registry http://www.isrctn.com/, the Dutch trial register (NRT) http://www.trialregister.nl/trialreg/index and the RePORT Expenditures and Results (RePORTER) query tool http://report.nih.gov. These registers will be consulted with a search combining ‘cancer’ with ‘care model’, ‘psychosocial’ and ‘screening’ or ‘assessment’.

Conference abstracts

We will search relevant research initiatives presented on the World Congress of Psycho‐Oncology by screening the abstract proceedings of the World Congresses organised from 2010 to 2015. This search and the trial register search are introduced to minimise publication bias.

Data collection and analysis

Data collection and analysis will be carried out in accordance with the guidelines published in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Selection of studies

All records retrieved from the electronic search in the databases, will be compiled in the reference database Endnote X6 and duplicates will be removed. Two review authors (BS and AVH) will independently screen titles and abstracts for relevancy. BS and AVH will inspect the full texts of the relevant records independently to judge on the eligibility using the inclusion and exclusion criteria. Reasons for exclusion will be documented. Possible cases of disagreement between the two review authors will be resolved by discussion or by involving a third or fourth independent review author (PV and TB). We will include a PRISMA flow‐diagram to display the screening process (Liberati 2009).

Data extraction and management

Two review authors (BS and AVH) will independently extract data from the included studies. Hereto, a data extraction form will be set up in accordance with the checklist proposed by Cochrane (Higgins 2011) and the CReDECI 2‐guideline (Mohler 2015). Where possible, the following data will be obtained from every study.

  • Study information: authors, publication year, source of publication, funding of studies and any conflicts of interest reported by authors.

  • Methods: study design, study duration.

  • Participants: country of recruitment, description of patient population, setting of recruitment, inclusion criteria, exclusion criteria.

  • Intervention: type of randomisation, aim of the study, content of screening or assessment, interventionist or executor of the concrete screening intervention, description of the screening or assessment intervention procedure (defined as ‘solitary screening intervention’ or ‘part of a more complex screening intervention’ added with a description of the intervention procedure), conditions for intervention implementation (e.g. necessary equipment for the screening, training for involved professionals, developed guidelines or handbooks, care or referral protocols, scheduled inter‐ or multidisciplinary meetings), theoretical basis of the studied screening or assessment intervention, description of the procedure for the comparative condition(s), protocol adherence, length of follow‐up.

  • Outcomes: primary and secondary outcome(s) defined by study authors, outcome time points.

  • Study results: sample size, number of participants on which the analysis is based, mean age of sample, ratio of gender in sample, results of primary outcomes relevant to the review focus, results of secondary outcomes relevant to the review focus.

  • Review authors’ conclusion: on the review authors’ primary outcomes of interest (QoL; HRQoL; distress; supportive care needs), and on the review authors’ secondary outcomes of interest (psychosocial well‐being measured by contributing components, defined by study authors as cognitive, emotional, psychological, social or spiritual well‐being, mental health, and symptoms of anxiety or depression; patients’ satisfaction).

  • Evaluation of potential bias: sample size calculation, sequence generation, allocation concealment, blinding, completeness of outcome data, reporting on outcome data, other sources of bias (e.g. interventions being insufficiently well‐delivered; the conduct of the study is affected by interim results; recruiting additional participants from a subgroup showing more benefit; an insensitive instrument is used to measure outcomes).

In case of disagreement, discussion will take place to reach consensus or an additional review author will be involved (PV, GB, JH, EVH, JM). When any of the record information is missing or unclear, we will attempt to contact the authors of the study to obtain further details.

Assessment of risk of bias in included studies

Randomised studies

Two review authors (BS and AVH) will independently assess the risk of bias of included RCTs by using Cochrane's tool for assessing the risk of bias (Higgins 2011). Each of the domains of potential bias will be labelled as ‘high risk’, ‘low risk’ or ‘unclear risk’. Possible disagreements between the two review authors (BS and AVH) will be resolved by discussion or involvement of a third review author (PV or GB).

Selection bias
Sequence generation

We will assess the method used to allocate participants to the conditions to check whether it could produce comparable groups. We will assess the methods as ‘low risk’ if random components are used (coin‐tossing; throwing dice; random computer assignment), ‘high risk’ if allocation is predictable (alternation; assignment based on date of birth; case record number and date of presentation), or ‘risk unclear’ if there is insufficient information to judge sequence generation.

Allocation concealment

We will evaluate the methods used to conceal the allocation sequence to determine whether condition allocation could be foreseen. We will label methods as ‘low risk’ if allocation could not have been foreseen (central or telephone randomisation; consecutively numbered sealed envelopes), ‘high risk’ if it could have been foreseen (printed lists of computer randomised allocation; unsealed envelopes; date of birth ), or ‘unclear risk’ if there is insufficient information to judge allocation concealment.

Performance bias

We will assess the methods used, if any, for blinding of study participants and personal from knowledge of the received intervention. These will be assessed as ‘low risk’ (participants and personnel blinded, or if we judge that not blinding could not have affected the results), ‘high risk’ (no or incomplete blinding), or ‘unclear risk’ if there is insufficient information on potential blinding.

Detection bias

We will evaluate the methods used, if any, for blinding outcome assessors from knowledge of the condition to which the participant was allocated. Methods will be labelled as ‘high risk’ (outcome assessor was familiar with the intervention the participant received), ‘low risk’ (outcome assessor not aware of the intervention the participant received), or ‘unclear risk’ if there is insufficient information to assess potential detection bias.

Attrition bias

We will assess the amount, nature, or handling of incomplete data to assess the attrition bias. We will assess methods as ‘low risk’ (e.g. no missing outcome data; missing outcome data balanced across groups), ‘high risk’ (e.g. missing data for one or more of the primary outcome measures, numbers or reasons for missing data unbalanced across groups), or ‘risk unclear’ if there is insufficient information to asses potential attrition bias.

Reporting bias

We will evaluate the data that support the assessment of selective outcome reporting. For this domain, we will code studies as ‘low risk’ (study protocol is available and all of the study’s pre‐specified outcomes are reported in a pre‐specified way, or the study protocol is not available, but it is clear that all the published reports include all expected outcomes including those that were pre‐specified), ‘high risk’ (not all the pre‐specified primary outcomes have been reported), or ‘unclear risk’ if there is insufficient information to evaluate reporting bias.

We will label a RCT as ‘low‐risk study’ if low risk of bias was found on the following three domains: adequate sequence generation, blinding of outcome assessors and selective outcome reporting in Cochrane's tool for assessing the risk of bias (Higgins 2011). In the case of high risk on these domains, the RCT will be labelled as a ‘high‐risk study’, and we will indicate that the risk of bias in a study is ‘unclear’ if there is no clear information on the risk of bias on several domains.

Non‐randomised controlled trials (NRCTs)

Two review authors (BS and AVH) will independently assess the risk of bias of included NRCTs by using the Risk Of Bias In Non‐randomized Studies ‐ of Interventions (ROBINS‐I) (Sterne 2016). With the ROBINS‐I, studies are assessed for their risk of bias on the following seven domains.

  • Bias due to confounding

  • Bias in selection of participants into the study

  • Bias in classification of interventions

  • Bias due to deviations from intended intervention

  • Bias due to missing data

  • Bias in measurement of outcomes

  • Bias in selection of the reported result

'Risk of bias' judgements will lead to labelling the studies on these domains as ‘critical risk’, ‘serious risk’, ‘moderate risk’, ‘low risk’ or ‘no information’. For the pre‐intervention and at‐intervention domains this is displayed in Table 1. Table 2 shows the way to reach 'Risk of bias' judgements for post‐intervention domains. Possible disagreements between the two review authors (BS and AVH) will be resolved by discussion or involvement of a third review author (PV or GB).

Table 1. Reaching risk of bias judgements in ROBINS‐I: pre‐intervention and at‐intervention domains
Judgement Bias due to confounding Bias in selection of participants into the study Bias in classification of interventions
Low risk of bias (the study is comparable to a well‐performed RCT with regard to this domain). No confounding expected. All participants who would have been eligible for the target trial were included in the study and start of follow‐up and start of intervention coincide for all participants. Intervention status is well‐defined and based solely on information collected at the time of intervention
Moderate risk of bias (the study is sound for a NRCT with regard to this domain but cannot be considered comparable to a well‐performed RCT.) Confounding expected, all known important confounding domains appropriately measured and controlled for;
and reliability and validity of measurement of important domains were sufficient, such that we do not expect serious residual confounding.		 Selection into the study may have been related to intervention and outcome, but the authors used appropriate methods to adjust for the selection bias;
or
start of follow‐up and start of intervention do not coincide for all participants, but (a) the proportion of participants for which this was the case was too low to induce important bias; (b) the authors used appropriate methods to adjust for the selection bias; or (c) the review authors are confident that the rate (hazard) ratio for the effect of intervention remains constant over time.		 Intervention status is well‐defined but some aspects of the assignments of intervention status were determined retrospectively.
Serious risk of bias (the study has some important problems). Switches in treatment, co‐interventions, or problems with implementation fidelity are apparent and are not adjusted for in the analyses. Proportions of missing participants differ substantially across interventions;
or
reasons for missingness differ substantially across interventions;
and
missing data were addressed inappropriately in the analysis;
or
the nature of the missing data means that the risk of bias cannot be removed through appropriate analysis.		 The methods of outcome assessment were not comparable across intervention groups;
or
the outcome measure was subjective (i.e. likely to be influenced by knowledge of the intervention received by study participants) and was assessed by outcome assessors aware of the intervention received by study participants;
or
error in measuring the outcome was related to intervention status.
Critical risk of bias (the study is too problematic to provide any useful evidence on the effects of intervention). Substantial deviations from the intended intervention are present and are not adjusted for in the analysis. (Unusual) There were critical differences between interventions in participants with missing data that were not, or could not, be addressed through appropriate analysis. The methods of outcome assessment were so different that they cannot reasonably be compared across intervention groups.
No information on which to base a judgement about risk of bias for this domain. No information is reported on whether there is deviation from the intended intervention. No information is reported about missing data or the potential for data to be missing. No information is reported about the methods of outcome assessment.
Source:Sterne 2016
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Table 2. Reaching risk of bias judgements in ROBINS‐I: post‐intervention domains
Judgement Bias due to deviations from intended intervention Bias due to missing data Bias in measurement of outcomes Bias in selection of the reported result
Low risk of bias (the study is comparable to a well‐performed RCT with regard to this domain). No bias due to deviation from the intended intervention is expected, for example, if both the intervention and comparator are implemented over a short time period, and subsequent interventions are part of routine medical care, or if the specified comparison relates to initiation of intervention regardless of whether it is continued. Data were reasonably complete;
or
proportions of and reasons for missing participants were similar across intervention groups;
or
analyses that addressed missing data are likely to have removed any risk of bias.		 The methods of outcome assessment were comparable across intervention groups;
and
the outcome measure was unlikely to be influenced by knowledge of the intervention received by study participants (i.e. is objective) or the outcome assessors were unaware of the intervention received by study participants;
and
any error in measuring the outcome is unrelated to intervention status.		 There is clear evidence (usually through examination of a pre‐registered protocol or statistical analysis plan) that all reported results correspond to all intended outcomes, analyses and sub‐cohorts.
Moderate risk of bias (the study is sound for a NRCT with regard to this domain but cannot be considered comparable to a well‐performed RCT). Bias due to deviation from the intended intervention is expected, and switches, co‐interventions, and some problems with intervention fidelity are appropriately measured and adjusted for in the analyses. Alternatively, most (but not all) deviations from intended intervention reflect the natural course of events after initiation of intervention. Proportions of missing participants differ across interventions;
or
reasons for missingness differ minimally across interventions;
and
missing data were not addressed in the analysis.		 The methods of outcome assessment were comparable across intervention groups;
and
the outcome measure is only minimally influenced by knowledge of the intervention received by study participants;
and
any error in measuring the outcome is only minimally related to intervention status.		 The outcome measurements and analyses are consistent with an a priori plan; or are clearly defined and both internally and externally consistent;
and
There is no indication of selection of the reported analysis from among multiple analyses;
and
there is no indication of selection of the cohort or subgroups for analysis and reporting on the basis of the results.
Serious risk of bias (the study has some important problems). Switches in treatment, co‐interventions, or problems with implementation fidelity are apparent and are not adjusted for in the analyses. Proportions of missing participants differ substantially across interventions;
or
reasons for missingness differ substantially across interventions;
and
missing data were addressed inappropriately in the analysis;
or
the nature of the missing data means that the risk of bias cannot be removed through appropriate analysis.		 The methods of outcome assessment were not comparable across intervention groups;
or
the outcome measure was subjective (i.e. likely to be influenced by knowledge of the intervention received by study participants) and was assessed by outcome assessors aware of the intervention received by study participants;
or
error in measuring the outcome was related to intervention status.		 Outcome measurements or analyses are internally or externally inconsistent;
or
there is a high risk of selective reporting from among multiple analyses;
or
the cohort or subgroup is selected from a larger study for analysis and appears to be reported on the basis of the results.
Critical risk of bias (the study is too problematic to provide any useful evidence on the effects of intervention). Substantial deviations from the intended intervention are present and are not adjusted for in the analysis. (Unusual) There were critical differences between interventions in participants with missing data that were not, or could not, be addressed through appropriate analysis. The methods of outcome assessment were so different that they cannot reasonably be compared across intervention groups. There is evidence or strong suspicion of selective reporting of results, and the unreported results are likely to be substantially different from the reported results.
No information on which to base a judgement about risk of bias for this domain. No information is reported on whether there is deviation from the intended intervention. No information is reported about missing data or the potential for data to be missing. No information is reported about the methods of outcome assessment. There is too little information to make a judgement (for example, if only an abstract is available for the study).
Source:Sterne 2016
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As prescribed in the manual of the ROBINS‐I, we will label a NRCT as a ‘low‐risk study’ if the study is judged to be at low risk of bias for all domains; as a ‘moderate‐risk study’ if the study is judged to be at low or moderate risk of bias for all domains; as a ‘serious‐risk study’ if the study is judged to be at serious risk of bias in at least one domain, but not at critical risk of bias in any domain; as a ‘critical risk study’ if the study is judged to be at critical risk of bias in at least one domain; and we will indicate that there is ‘no information on a NRCT‘ if there is no clear indication that the study is at serious or critical risk of bias and there is a lack of information in one or more key domains.

For the NRCT, we will check if covariance analyses were performed. This way there is a correction of the results in function of potential influences from other variables than the intervention of interest, and the risk of bias in results is reduced.

Measures of treatment effect

We expect different PROMS to be applied across studies to measure participants well‐being. We will analyse continuous data of similar measures with the mean difference (MD) and use standardised mean difference (SMD) when measures are different. For dichotomous data, we will present results as risk ratio (RR). The method for handling ordinary scales will depend on the length of the scale. We will use the RR for scales that can be dichotomised, and for five‐point Likert scales or longer, we will calculate the MD. For all measures of treatment effect we will determine the 95% confidence intervals (CIs).

Unit of analysis issues

Cluster‐RCTs examining the effect of screening and assessment on the psychosocial well‐being and care needs of cancer patients will be included. The results will be analysed together with individually‐randomised trials after adjustment of the sample sizes as described in the Cochrane Handbook of Systematic Reviews of Interventions (Higgins 2011). For this purpose, an estimate of the intra‐cluster correlation coefficient (ICC) will be used, preferably from a similar trial. If no such estimate is available, a conservative ICC of 0.05 will be used. We will assess the impact of cluster‐RCTs on the results in a sensitivity analysis.

Dealing with missing data

In the case of missing data, we will attempt to contact study authors for additional information. If we do not succeed to complete the minimum data needed for a meta‐analysis, the respective study will be excluded from the meta‐analysis.

Assessment of heterogeneity

We expect to observe some heterogeneity, induced by clinical and methodological diversity (specified in Subgroup analysis and investigation of heterogeneity). We will only perform meta‐analysis when a group of studies is sufficiently homogeneous to provide a meaningful summary; if not we will perform a narrative data synthesis. In our meta‐analysis, we will use the Chi2 test included in the forest plots to examine heterogeneity in intervention effects. We will calculate the I2 statistic to quantify inconsistency of the observed effects. With this, the percentage of the variability in effect estimates that is due to heterogeneity rather than sampling error (chance) will be calculated. We will adopt the guide for interpretation suggested by the Cochrane Handbook of Systematic Reviews of Interventions (Higgins 2011):

  • 0% to 40%: might not be important;

  • 30% to 60%: may represent moderate heterogeneity;

  • 50% to 90%: may represent substantial heterogeneity;

  • 75% to 100%: considerable heterogeneity.

The significance of the observed value will be interpreted in the context of the magnitude and direction of effects, and on the strength of evidence for heterogeneity (e.g. P value from the Chi2 test, or a confidence interval for I2).

Assessment of reporting biases

In order to assess publication bias, we will produce funnel plots (estimated treatment effects against their standard error). Funnel plot asymmetry will be tested statistically when there are at least 10 studies included in the meta‐analysis. Asymmetry could be due to publication bias, but could also be due to a relationship between trial size and effect size. In the event that a relationship is found, we will examine clinical diversity of the studies, selection biases and poor methodological quality as alternative explanations to publication bias.

Data synthesis

If two or more eligible studies are identified and found to be homogeneous, we will perform a meta‐analysis using Review Manager 5.3 (RevMan 2014). We will perform a narrative data description of the study results of each individual study, in case studies are too heterogeneous. A random‐effects model will be used as we expect at least some heterogeneity between the studies.

Subgroup analysis and investigation of heterogeneity

Studies with a RCT design and studies with a NRCT design will be seen as two subgroups in the analysis of results. If there is agreement in the conclusions resulting from RCTs and NRCTs, one final conclusion on the effect of screening and assessment of psychosocial well‐being and care needs can be formulated.

If considerable heterogeneity in outcome is found (I2 > 75%) within these two subgroups of studies, we will try to explain the heterogeneity by assessing potential differences in clinical characteristics. We imagine that potential heterogeneity in outcomes could be induced by clinical and methodological characteristics: patient characteristics (e.g. age group, gender), medical characteristics (e.g. cancer type, disease prognosis or stage, type and degree of (pre‐) treatment), or characteristics of the intervention of interest (e.g. simple or complex screening of psychosocial well‐being and care needs, studies that address more than one relevant intervention condition). If we find that several studies are focused on these specific characteristics, we will perform subgroup‐analyses.

Sensitivity analysis

We will conduct a sensitivity analysis to assess the robustness of our findings. After all, intervention effects could be larger in NRCTs and RCTs of less quality by overestimation. However, this could equally be the other way around and effects could be underestimated in RCT studies (Sidani 2015). We will start with a meta‐analysis including the low risk of bias RCTs and NRCTs separately. Subsequently, we will conduct a repeated meta‐analysis with both, and explore the impact on the final results. With this we will explore the effect of including NRCTs in this review.

Acknowledgements

This review is part of a PhD funded by Limburg Sterk Merk (LSM). We would like to thank Karen Galway for clinical advice and the Cochrane Gynaecological, Neuro‐oncology and Orphan Cancers for their support and guidance in conducting this review. This project was supported by the National Institute for Health Research, via infrastructure funding to Cochrane Gynaecological, Neuro‐oncology and Orphan Cancers. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Appendices

Appendix 1. Search strategy MEDLINE

Search strategy MEDLINE (through Ovid)

1. exp Neoplasms/ 2. (cancer* or tumor* or tumour* or neoplas* or carcinoma* or adenocarcinoma* or malignan* or oncolog* or psycho‐oncolog*).mp. 3. 1 or 2 4. "Quality of Life"/ 5. exp Health Status/ 6. Stress, Psychological/ 7. exp Adaptation, Psychological/ 8. exp Anxiety/ 9. Depression/ 10. Social Support/ 11. (quality of life or QOL or HQOL or HRQOL).mp. 12. (cope or coping).mp. 13. (social support or care need*).mp. 14. ((psychosocial or psycho‐social or psychological or social or emotion* or cogniti* or marital or relational or sexual or financial or spiritual or famil*) adj5 (wellbeing or well‐being or difficult* or function* or dysfunction*)).mp. 15. (health adj status).mp. 16. (distress* or stress* or anxiety or anxious* or depress*).mp. 17. ((psychiat* or adjustment) adj5 disorder).mp. 18. 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 19. "Outcome Assessment (Health Care)"/ 20. patient outcome assessment/ 21. (PROM or PRO).mp. 22. patient reported outcome*.mp. 23. interview/ 24. Interview, Psychological/ 25. exp Questionnaires/ 26. (questionnaire* or interview*).mp. 27. ((psychosocial or psycho‐social or psychological) adj5 (screen* or assess* or report* or survey* or scale* or instrument*)).mp. 28. exp Psychiatric status rating scales/ 29. (systemat* adj5 assess*).mp. 30. Screen*.mp. 31. (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30).mp. 32. EORTC‐QLQ‐C30.mp. 33. (Short Form Health Survey or SF36).mp. 34. ((Hospital Anxiety and Depression Scale) or HADS).mp. 35. (Distress Thermometer or DT).mp. 36. (Beck Depression Inventory or BDI).mp. 37. (Supportive Care Needs Survey or SCNS or Cancer Survivors Unmet Needs or CaSUN).mp. 38. EORTC IN‐PATSAT32.mp. 39. ((Patient Satisfaction and Quality in Oncological Care) or PASQOC).mp. 40. 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37 or 38 or 39 41. 3 and 18 and 40 42. randomized controlled trial.pt. 43. controlled clinical trial.pt. 44. randomized.ab. 45. placebo.ab. 46. clinical trials as topic.sh. 47. randomly.ab. 48. trial.ti. 49. ((before‐after or (before and after)) adj (study or studies)).mp. 50. (CBA adj (study or studies)).mp. 51. interrupted time series.mp. 52. (ITS adj (study or studies)).mp. 53. (repeated measure adj (study or studies)).mp. 54. ((RMS or rms) adj (study or studies)).mp. 55. (historical* control* adj5 (study or studies)).mp. 56. ((HCT or hct) adj (study or studies)).mp. 57. 42 or 43 or 44 or 45 or 46 or 47 or 48 or 49 or 50 or 51 or 52 or 53 or 54 or 55 or 56 58. 41 and 57 59. exp animals/ not humans.sh. 60. 58 not 59

key: mp=title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier b=abstract ti=title sh=subject heading pt=publication type

Contributions of authors

  • Conceptualising the topic for the review: BS, AVH, JH, EVH and PV

  • Writing and editing the protocol: BS, AVH and GB

  • Reviewing the protocol: EVH; JH, PV, JM

  • Development of search strategy: BS and AVH

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • There are no external sources of support in terms of funding for the review, Other.

Declarations of interest

Bojoura Schouten: None known Geertruida E Bekkering: None known Patrick Vankrunkelsven: None known Jeroen Mebis: None known Elke Van Hoof: None known Johan Hellings: None known Ann Van Hecke: None known

New

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