A proof-of-concept study of iCope: A nurse-led psychoeducational telephone intervention for women attending a rapid diagnostic centre for breast abnormality

Abstract

The period between the initial discovery of a suspicious breast lesion and a confirmed diagnosis is a time of significant psychological distress, heightened anxiety, and uncertainty for many women. This proof of concept (PoC) study explored the clinical outcomes and acceptability of iCope, a nurse-led psycho-educational telephone intervention aimed to assist with uncertainty, anxiety and coping in women going through a Rapid Diagnostic Centre (RDC) offering quick diagnosis of breast cancer (same day to three-day post-investigation). Guided by the Uncertainty Theory, and using a one-arm pretest-posttest design, two brief 15-minute telephone sessions were delivered by a nurse prior to the women’s day of testing at the RDC and three days after the receipt of their results. Six women completed measures of anxiety, uncertainty, and coping before the clinic visit, three days and three weeks after receiving their test results. Results show that the implementation of the telephone intervention was challenging, yet may offer potential for positive impact. That is, trends of decreased uncertainty and anxiety in participants over time were noted. Considering the difficulty observed in the recruitment and delivering the two interventions in the timeline planned, feasibility testing is recommended before the conduct of a large-scale study.

INTRODUCTION

The period between the initial discovery of a suspicious breast lesion and a confirmed diagnosis is a time of significant psychological distress, heightened anxiety, and uncertainty for many women (Iwatani et al., 2013; Keyzer-Dekker et al., 2014; Morse et al., 2014; Singh et al., 2017; Zhang et al., 2018). Oncology nurses are on the frontline addressing the adverse psychological effects experienced in this patient population. For instance, nurses are able to anticipate some of the distress and offer emotional support and educational resources to anxious individuals.

Rapid diagnostic clinics (RDCs) have been introduced to shorten wait times for breast cancer screening and, thus, reduce this type of patient distress in the diagnostic phase (Barentsz et al., 2014). Overall, these centres have been shown to provide a high degree of diagnostic accuracy, reduce time to confirmation of diagnosis, and provide for a satisfactory care experience for patients (Barentsz et al., 2014; Delaloge et al., 2016). A key outcome of the RDC model is to reduce patients’ short-term anxiety related to the diagnostic process (Singh et al., 2017). In a study of patients with suspected lung cancer, Brocken et al. (2015) found a similar decrease in anxiety in a rapid diagnostic care pathway compared to patients in a standard wait-time pathway.

Oncology nurses are clinically prepared to respond effectively and competently to such diagnostic innovation and lead the psychosocial and clinical care needed to support patients, as they attend RDC for further testing (Zanchetta et al., 2015). Given the especially short timeframe for the RDC process from pre-diagnosis to diagnosis of breast cancer, interventions to assist in managing the high-anxiety waiting period to the diagnosis phase must be prompt and timely. Although the diagnostic phase can be marked with intense emotional distress, this phase is often overlooked in research (Brocken et al., 2012; Keyzer-Dekker et al., 2014).

Psycho-education has been used to help patients with cancer adjust to changes in emotions and distress, by helping them to obtain, and interpret information, solve problems and discuss needs related to their diagnosis (Maheu et al., 2015; Zanchetta et al., 2015). Psycho-educational interventions can help individuals undergoing additional breast cancer screening following the discovery of a suspicious breast lesion to manage this period of anxiety and uncertainty, thereby ameliorating the person’s experience during this highly intense wait for follow-up tests. Receiving psycho-educational support, as part of rapid diagnostic testing for breast cancer, is also helpful to individuals who receive a benign diagnosis. The psychological distress experienced by individuals who go through RDC for breast cancer can be similar for both who receive benign or malignant diagnosis (Brual et al., 2020; Iwatani et al., 2013). Proper psycho-educational support to both groups before and after testing is recommended (Singh et al., 2017).

Numerous variables of psychoeducational interventions can be modified to suit the timeline and needs of a certain population; mode of delivery, format, frequency, timing, and content can vary as needed. In one nursing-led study evaluating the use of a psycho-educational telephone intervention for women with breast cancer undergoing genetic testing for BRCA1/2, results revealed a reduction in anxiety and uncertainty (Maheu et al., 2015). Further, the telephone intervention was reported as satisfactory and easily accessible for both the receiver and the provider (Maheu et al., 2015).

iCope: A Theoretical Model of a Nurse-Led Psychoeducational Telephone Intervention

The development of the nurse-led brief psycho-educational telephone intervention to manage anxiety and uncertainty in individuals attending a rapid diagnostic clinic for breast abnormality, iCope, was guided by the Mishel Uncertainty in Illness model (Mishel, 1988) and principles from brief cognitive-behavioral therapy (CBT). Mishel defines uncertainty as “the inability to determine the meaning of illness-related events” (Mishel, 1990). This inability may be especially acute in a complex situation, such as a diagnostic workup, where the patient is overwhelmed with an abundance of unfamiliar cues. When a situation is appraised negatively, anxiety becomes a covariate of uncertainty. Thus, one can anticipate that a reduction in uncertainty could, in turn, lead to a reduction in anxiety. While the Uncertainty Theory provides the means to understand how uncertainty builds and creates anxiety, CBT provides strategies to act upon the factors and variables that influence uncertainty such as cognitive reframing, gaining control through applied coping skills, unfreezing the fear, and provision of formal support (Cully & Teten, 2008; Greer et al., 2012).

With these structures in mind, the aim of the first telephone session prior to testing was to provide psycho-educational support through teaching brief CBT and decrease uncertainty apprehension by providing information and understanding of possible tests to be conducted on the day of testing for breast cancer diagnosis. The uncertainty theory explains that providing event familiarity can assist to reduce uncertainty and seeing the event as an opportunity, thereby reducing anxiety (Hoff et al., 2002; Mishel, 1990). The provisions of educational material for a coming event assist with obtaining event congruency, another uncertainty stimuli. The second telephone intervention provided three days post-RDC results and serves as an enhancement to previously applied appraisal with a focus on the outcome of their RDC results.

Both sessions are planned to last an average of 15 minutes. In each session, the goal is to assist in building a reality-based appraisal of the situation, reduce the apprehension of the day of testing, strengthen coping skills, and obtain guidance in cognitive reframing and in the use of relaxation techniques.

Existing research on the efficacy of nurse-led psycho-educational interventions to improve psychological outcomes and coping for patients going through the RDC pathway is limited and restricted to descriptive data (Brocken et al., 2012; Liao et al., 2010). Multi-phase paradigms for developing and testing mind and body interventions, as presented by the National Institute of Health (NIH) (National Institute of Health, 2021), suggest beginning the process with studies that demonstrate clinically meaningful signals. In keeping with this NIH recommendation, the purpose of this proof of concept study was to explore the acceptability and clinical outcomes of iCope, a nurse-led psycho-educational telephone intervention for women attending an RDC for breast abnormality on levels of uncertainty, anxiety, and coping.

METHODS

Design

The design is a single-arm pretest-posttest proof of concept intervention study. The study was carried out with six women to test the acceptability of the telephone intervention and to explore possible clinical outcome signals on levels of uncertainty, anxiety, and coping.

Participants and Recruitment

Recruitment took place in an RDC at one of the major cancer centres in Toronto, Ontario from January 2018 to June 2018. In this RDC, an average of one hundred patients is seen each month with a 40% rate resulting in a malignant diagnosis. Patients referred to the clinic were eligible if they were women over age 18, English-speaking with no previous cancer diagnosis, and scheduled to receive further diagnostic testing following the identification of breast abnormality. Ethics approval was received from the recruiting site UHN #14-8092-CE and the nominated principal investigator’s primary affiliated site McGill University #A02-B15-15B.

Recruitment procedures of the convenience sampling were as follows. All women who were referred to the RDC for further testing were eligible for the study. The first contact to seek interest in participating was done by the RDC admission clerk. Women who voiced interest in taking part in the study were then referred to the research coordinator. In the second contact, the research coordinator further explained the study, obtained verbal consent, sent the study link to complete the study questionnaires or completed the questionnaires during this telephone contact if the participant had time, and scheduled an appointment to have the first nurse-led telephone session prior to the date of the participants’ testing appointment at the RDC.

Measures

When possible, and if they agreed, after participants consented to the study, they were asked to complete the study outcome baseline questionnaires (T1) over the telephone with the research coordinator. If they could not complete the baseline measure at that time, they were sent a Web-based version of the questionnaires using Lime survey. Outcome study questionnaires were also completed within three days following attending the RDC for testing (T2) and three weeks (T3) post-testing. At baseline, the demographics assessed included age, education, employment, race, and how the breast abnormality was first detected.

Exploration for clinical outcomes from iCope was assessed using validated scales measuring uncertainty, anxiety, and coping. Uncertainty was measured using the Mishel Uncertainty in Illness Scale – Community form (MUIS-C) (Mishel, 1997). The MUIS-C is a 23 unidimensional items scale with responses rated on a five-point Likert scale ranging from 23 to 115 with a mid-range score of 69 and normative values for breast cancer identified at 33.4 (M. Mishel, 1997; M. H. Mishel, 1997). In our study, alpha coefficients ranged from 0.88–0.97. Anxiety was measured using the Spielberger’s State-Anxiety scale (STAI-S) (Spielberger, 1983) a 20-item scale with responses rated on a four-point Likert scale ranging from 20 to 80. We used the commonly used mid-range clinical cut-off of 40 (Emons et al., 2019; Ercan et al., 2015; Knight et al., 1983). Alpha coefficients in our study ranged from 0.94 to 0.97. Coping was measured using four selected sub-scales from the fourteen Brief Cope survey (Carver, 1997). Each sub-scale contains two items, rated on a four-point Likert scale and scores range from 2 to 8. The four subscales relevant to our study were the use of self-distraction, emotional support, active coping, and positive reframing. Intervention acceptability was assessed by having participants respond to an open question added at T3: “How essential and useful did you find the first and the second telephone interventions to help you manage your uncertainty, apprehension, and to help you cope with your RDC testing?”

Intervention

iCope is a manualized intervention and outlines steps to the first and second telephone consultations. The timing of the intervention delivery is displayed in Figure 1. Participants received two telephone consultations with the principal investigator, a trained oncology nurse researcher with expertise in psychosocial cancer care. The first telephone consultation occurs 1 to 3 days prior to attending the RDC for further disease-based testing and the second, within two to four days following receipt of RDC results. The overall goals of the first telephone nurseled consultation are to guide the women toward a reality-based appraisal of their situation, reduce apprehension, improve the women’s understanding of the day’s event, including the likely medical procedures to be done, and enhance their coping abilities to manage uncertainty through skills such as cognitive reframing and relaxation techniques. Concepts and content reviewed in the first telephone psychosocial intervention include participants’ understanding of their medical tests to be done, their current state of uncertainty and anxiety; a brief introduction of cognitive restructuring skills and its application with episodes of automatic negative thoughts; and a review of current use of coping skills such as using calming self-talk phrases, relaxation audio, deep breathing through moments of anxiety, and obtaining family and friends’ support. These skills-building learning objectives were selected, as they have been identified as influential variables in the uncertainty theory (Mishel, 1988) and there is evidence to support their use in managing uncertainty and anxiety (Lebel et al., 2018; Maheu & Thorne, 2008; Maheu et al., 2021).

Figure 1.

Study Procedure Flowchart

To assist in understanding the day’s events, the nurse directs the study participants to view the RDC website that provides a video that outlines what to expect, what are the probable medical procedures (i.e., a video on how to prepare for your visit to the RDC and types of tests that can be done such as guided breast biopsy), and how to prepare for their visit to the RDC. The RDC nurse practitioner’s contact information was also provided to the participant. The uncertainty theory explains that having structure providers in place, such as having a credible authority they can contact for information, and having educational and social support, can positively influence levels of uncertainty. As structure providers, nurses can change the stimuli frame through interpretation, explanation, and clarification of the day’s events. After the end of the first telephone session, the nurse delivering iCope sends an email summary of the telephone exchange including links to the RDC website containing information and videos of the possible tests that could be undertaken, links to online coping tools, and relaxation audios to help manage anxiety and uncertainty.

The second telephone intervention occurs three days following receipt of the RDC test results. The aims of this second nurse-led telephone session were to reinforce the coping and relaxation skills previously reviewed in the first session and to discuss which skills the participants felt helped them manage the uncertainty and anxiety. The participants were also reminded to review the RDC website to assist in comprehending their results (either benign or malignant) and, if needed, that they could contact the RDC nurse practitioner if they had additional questions about their test results that could not be answered by the information on the RDC website.

Data Analysis

Due to the small sample size, nonparametric statistics were used to assess the clinical outcome of uncertainty (MUSIC-C), anxiety (STAI), and coping at the different time points (pre-RDC testing [T1], three days [T2], and three weeks post RDC testing [T3]). Observed change in each clinical outcome was assessed with Friedman testing (χ2) with the main factor “time” (three levels: T1, T2, and T3). To disclose the significant changes between the sample median against the time points, the Wilcoxon signed test (z) was then applied. Missing values were replaced with the median of the group. All statistical analyses were completed using SPSS^(c) version 23 (IBM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp.), and a p-value <0.05 was considered as significant. The response to the open question asked at T3 on the acceptability of iCope by the study participants was transcribed and analyzed using a qualitative description approach (Sandelowski, 2000, 2010), a summarization of the participants’ experience of their engagement with the two nurse-led telephone interventions.

RESULTS

Demographic and medical data

Eleven participants were approached for the study and six consented to participate. The women who declined participation reported not needing additional support from a nurse. All six participants completed the baseline questionnaire (T1) and both telephone sessions. Four participants learned of their benign diagnosis prior to receiving the second telephone session and had completed T2 and T3 study measures. The last two participants were subsequently scheduled for additional testing and had not yet received their results when they took part in the second telephone session. Although they had been invited to complete their T2 and T3 study measures, they did not return their questionnaires.

Of the six participants, the mean age was 49, the majority had received college or university education, and were employed full-time. The ethnicity among the group was slightly diverse with four being White, one Latin American, and one Eastern Indian. The initial breast abnormality was detected in the participants using radiological testing (n = 3), self-breast exam (n = 2), and clinical breast exam (n = 1).

Effects on clinical outcomes of uncertainty, anxiety, and coping

At baseline, all six participants had uncertainty scores higher than the normative value for breast cancer of 33.4 (M. Mishel, 1997; M. H. Mishel, 1997), two of the participants had anxiety (STAI) scores higher than the midrange of 40 (Emons et al., 2019; Ercan et al., 2015; Knight et al., 1983), and half of the participants had coping scores below the mid-range of 4.

A comparison of the median scores on all three time points measured using the Friedman test revealed a significant effect of time on anxiety and uncertainty, both with values of χ2 (2, n = 18) = 10.333, p = 0.006. The medians from Table 1 indicate that the scores were at their lowest at T3 for uncertainty (Md = 44 vs 53.2 at T2) and for anxiety (Md = 11.5 vs 31.5 at T2). Using Wilcoxon signed-rank tests (positive and negative rankings), significantly less positive rankings in uncertainty were noted at T2 compared to T1 (z = −1.992, p = 0.046) and at T3-T2 (z = −2.214, p = 0.027). Similar results were found for anxiety with lower scores at T3 compared to T2 (z = −2.207, p = 0.027). Two of the four coping strategies were significant over time with use of active coping (χ2 = 7.182, p = 0.028), and positive reframing (χ2 = 8.400, p = 0.015). Specifically, at T3 compared to T2, Wilcoxon-rank tests revealed an increase in use of active coping (z = −2.060, p = 0.039), and positive reframing (z = −2.041, p = 0.041).

Table 1.

Outcome Measures of Uncertainty, Anxiety, and Coping at the Three Time-Points Measures (n = 6)

Variable (range score)	Time 1 (Mdn)	Time 2 (Mdn)	Time 3 (Mdn)	p-value
Uncertainty (23 to 115)	69	53.2	44	0.006
State Anxiety (20 to 80)	34	31.5	11.5	0.006
Brief Cope / Active Coping	5	6	7	0.006
Brief Cope / Self Distraction	5	7	7.5	ns
Brief Cope / Emotional Support	6	7.75	7	ns
Brief Cope / Positive Reframing	2	3	3.5	0.041

Note: Uncertainty normative value for breast cancer is 33.4; State anxiety clinical level is 40; Brief cope, higher scores indicated higher levels of the construct. Mdn = Median; p-values are derived from Friedman testing on T1, T2, and T3. p-values <0.05 were considered significant.

Acceptability of iCope

Only four of the six women provided their T3 measures and could comment on the acceptability of receiving the two telephone interventions. All four expressed high levels of satisfaction from the attention and information received by the nurse prior to attending the RDC for testing and four days following receipt of their results. They particularly appreciated being made aware of the RDC website link that provided information about the day’s event, and the coping skills reviewed to manage anxiety and uncertainty such as the use of cognitive reframing, re-appraising the day’s event as an opportunity, and receiving links to relaxation techniques. All four felt that fifteen-minute telephone contact was sufficient to have their questions answered and to obtain the support necessary to prepare for the day’s event and interpret the result. They also valued receiving the e-summary notes following each telephone intervention.

One aspect of acceptability assessed was the ability to identify potential participants and conduct the two planned study telephone interventions. Early into the study, the research team noted that recruitment was a challenge given the short time frame of 36 to 48 hours to identify and recruit a participant before they would be scheduled to attend the RDC to receive further testing. In agreement with the RDC, the research team had organized the recruitment plan so that the RDC clerk that would first identify potential participants from the list of referrals received, also would contact the individuals for their permission to have the research team approach them to further explain the study, and would seek their consent to participate. Often the recruitment failed. Potential participants were not approached quickly enough by the RDC clerk prior to them receiving their RDC appointment. Often, the short time frame left little time for the research coordinator to connect with and consent the potential participants, and to book an appointment to receive their first 15-minute iCope telephone intervention prior to their scheduled RDC testing. Initially, the recruitment goal for the study was 15 participants, but recruitment concluded early given the difficulty of consenting and implementing the two study telephone interventions for the reasons descibed above. The difficulties encountered resulted in enrolling just six participants in the course of a six-month period.

DISCUSSION

This paper reports the results of a preliminary study exploring the clinical outcomes and acceptability of a nurse-led psycho-educational telephone intervention for uncertainty, anxiety, and coping in women with a suspicious breast abnormality attending an RDC. Previous research indicates that going through RDC for breast abnormality creates high levels of anxiety and uncertainty (Iwatani et al., 2013; Keyzer-Dekker et al., 2014; Morse et al., 2014; Ratzinger et al., 2012; Van Esch et al., 2012; Zhang et al., 2018). In our study, although we recognize the sample size was small (n = 6), all six participants experienced high levels of uncertainty above normative values; two had anxiety scores above clinical levels at pre-RDC testing, one at three days post-testing, and none following the second telephone intervention. Following each telephone intervention, a marked decrease in uncertainty was noted.

Although this study did not measure whether individual educational needs were met, and only four participants provided feedback regarding acceptability with the iCope intervention, all four expressed high satisfaction with the intervention and the educational resources provided by the nurse delivering the intervention. A study examining the informational needs of over a hundred women receiving rapid diagnostic testing for breast abnormality and cancer testing revealed that receiving information on the medical procedures to be done was more important than information on support and coping (Brual et al., 2020). In our study, we observed an increase in the use of active coping (e.g., seeking information, social support, professional help) and positive reframing (e.g., seeing the RDC day’s event as an opportunity to obtain certainty rather than seeing the day’s event as a threat). It is likely that the increased use of coping behaviours may have contributed to the lower levels of anxiety and uncertainty observed following both telephone interventions. As we know, when uncertain future events are viewed as a threat, it may trigger higher levels of worry, and anxiety, and can lead to the inability to function (Gu et al., 2020). Although larger sample size is necessary to draw conclusions regarding the effectiveness of iCope, findings suggest that a larger study with a more robust sample and a more efficient recruitment approach would be worthwhile to investigate.

Limitations

The sample size of six (with four participants completing all three measures) is too small to draw conclusions regarding the association between the intervention and clinical outcomes. Additionally, confounding variables were not considered in the current analyses. For instance, the diagnosis might have impacted changes in levels of anxiety and uncertainty between baseline and follow-up measures. As such, it is possible that the decrease in anxiety and uncertainty is associated with receiving a benign diagnosis rather than the psycho-educational intervention, iCope. Nonetheless, the findings show trends worth exploring in a larger scale study, while also highlighting the limited time for offering the intervention as a potential barrier to implementation.

Recruitment methods would need to be adjusted prior to beginning a larger-scale study. The nurse providing iCope would need to have a great degree of flexibility and availability in order to conduct the telephone interventions within the necessary timeframe. Due to the sensitivity of the telephone calls and that the call was coming from the RDC, messages were not left for the participants to mitigate any undue stress. All engagement with the participants was undertaken only if the patient answered the call. This posed a severe limitation in recruiting patients within the 24–36-hour timeframe.

Recommendations for Future Research

In future studies, methods to improve the efficiency of recruitment and retention procedures, such as automated prompting for initial recruitment, completion of questionnaires online, and reminders of upcoming sessions, are recommended. To streamline the number of individuals to receive iCope, considering the short time frame available to intervene, a recommendation would be to trial this intervention in those presenting with high levels of anxiety and uncertainty at baseline (upon sending their referral to the RDC) using the STAI and MUSIC-C questionnaires. There is also a need to assess if the second telephone intervention should be adapted to fit the participant’s RDC results of either benign, malignant, or needing further testing, as it happened for two of the six women who took part in this study. As they did not complete the last two study measurements, it is unknown what benefits they could have obtained with the current version of iCope.

CONCLUSION

Providing brief, evidence-based interventions for the management of uncertainty and anxiety is particularly important for individuals going through RDC testing where assessment and diagnosis happen in a short time frame. This small-scale single-arm pretest-posttest study is limited by the small sample size and the lack of a control group in the study design. However, the preliminary results show a clinical signal, and participants reported satisfaction with the trialed intervention. A larger feasibility pilot trial with a control group for comparison would be the next step to further evaluate the efficacy of this nurse-led brief psycho-educational telephone intervention to reduce anxiety and uncertainty for women with suspected breast abnormality attending an RDC.