Background
Breast cancer negatively affects patients’ sexuality and intimacy, leading to physical (eg, vaginal dryness) and emotional problems (eg, body image distress).1–6 These sexual problems tend to persist beyond initial treatment even as other quality of life (QoL) concerns improve.1,7,8 Guidelines set forth by NCCN and ASCO urge breast cancer clinicians to discuss treatment-related sexual adverse effects with their patients in their routine cancer care,9–11 and most women diagnosed with breast cancer want clinicians to discuss these issues as part of their care.12,13 However, only 30% to 40% of women report that their clinicians discussed sexual concerns with them.13,14 A key factor underlying this lack of communication is a lack of training in discussing sexual health and related concerns.15–17
Previously, we tested a brief intervention aimed at enhancing breast cancer clinicians’ communication regarding their patients’ sexual health concerns, called improving Sexual Health and Augmenting Relationships through Education (iSHARE).18 The intervention consisted of education and skills training using a self-study workbook followed by a 1-hour in-person small group workshop. In a pilot study involving 7 clinicians and 134 patients with breast cancer, positive effects were seen in clinicians’ communication about sexual health concerns measured during routine clinic encounters, as well as in their confidence, or self-efficacy, with engaging in such communication. However, although the content was well received, the in-person group format presented challenges for recruitment and implementation and would require significant resources to be disseminated.
To address these limitations while leveraging the potential of iSHARE, we aimed to adapt this intervention to a mobile-accessible (mLearning) format and pilot test it. The present study thus investigated the feasibility, acceptability, and preliminary effects of the new iSHARE mLearning intervention, consisting of an educational 2-part podcast series, on breast cancer clinicians’ knowledge of, beliefs about, and comfort with discussing patients’ sexual health concerns in a pilot study. We also explored clinicians’ perspectives on the key lessons they gained from the intervention (ie, lessons learned) through a qualitative analysis.
Methods
Research Design and Setting
A single-arm repeated measures design with baseline and postintervention measures was used to meet study objectives. This study was approved by the Institutional Review Board at Fox Chase Cancer Center (#18-1068) and was entered prospectively on ClinicalTrials.gov (identifier: NCT04262219).
Participants
Medical oncologists or oncology advanced practice clinicians treating patients with breast cancer were eligible to participate. Clinicians who had participated in the trial of the iSHARE intervention in its initial format were excluded.18
Recruitment and Procedures
Clinicians were recruited from Fox Chase Cancer Center, community hospitals, and other institutions either during staff meetings or through direct contact with the principal investigator or colleagues. Introductory emails were sent to potentially eligible clinicians and included links to a REDCap19,20 form asking clinicians to provide contact information and complete an eligibility screening questionnaire. Automated links for eligible participants were then provided for completing online consent and, after consent, the baseline survey. Participants were mailed $50 gift cards for completing baseline and postintervention surveys ($100 total).
iSHARE Intervention
The iSHARE intervention content was informed by formative qualitative research,21 models of clinical communication skills development,22–24 and social cognitive theory, which emphasizes individuals’ beliefs (ie, self-efficacy and outcome expectancies) as critical processes underlying successful behavioral interventions.22,25–28 We adapted the intervention from the previous iSHARE format (written materials and in-person small group workshop)18 to the new mLearning format using expert review and structured cognitive interviews with medical oncology fellows that provided feedback on scripts guiding interviews featured in the podcast series.29 The resulting intervention consisted of a 2-part podcast series featuring 2 episodes with 30-minute one-on-one interviews with expert guests led by the principal investigator (J.B. Reese) in a semistructured question-and-answer format (see Table 1 for content description). Episodes were distributed to clinicians through the REDCap platform; clinicians could listen on any device by clicking on a link emailed to them (smartphone, computer, tablet).
Content of iSHARE Intervention
Data Collection
Data were collected from participants after consent (baseline) and after intervention completion (postintervention); acceptability items and knowledge items were asked after each episode rather than at postintervention in order to assess clinicians’ perspectives of the episode-specific content and accurately gauge intervention effects on knowledge.
Measures
Feasibility
Feasibility was measured through rates of enrollment (ie, percent of eligible participants approached who enrolled), retention to study completion (ie, percent of consented participants who completed all study surveys), and intervention completion (ie, percent of participants who indicated that they listened to both podcast episodes). Benchmarks for enrollment (≥40% of eligible participants), retention (≥70%), and intervention completion (>60%) were based on our previous iSHARE study18 but were lowered slightly because we were recruiting mostly clinicians external to the study site.
Acceptability
Acceptability was measured through standard self-report items assessing clinicians’ perspectives of the intervention content and format (eg, satisfaction, relevance, ease of listening, likelihood of recommending to colleagues, likelihood of impacting practice). Responses were on a 5-point scale ranging from “very” to “not at all.” The benchmark for acceptability was met if 75% of participants in the sample endorsed at least 75% (9/12) of the acceptability items favorably (“quite a bit” or “very”). In addition, a single open-ended question asked clinicians for the “one takeaway message” they received from each of the 2 podcast episodes (ie, lessons learned); these data were analyzed qualitatively.
Knowledge
Knowledge about sexual response/breast cancer–related sexual adverse effects, common approaches and resources, and necessary communication skills for addressing sexual issues were assessed using 10 multiple-choice items adapted from those used in prior studies30–32 through expert review; an equal number of items assessed knowledge relevant to each of the 2 episodes. The sum of correct responses was used.
Beliefs
Items developed for the initial iSHARE study based on social cognitive theory25,33 assessed self-efficacy for communicating with patients with breast cancer about sexual health concerns (3 items), and outcome expectancies for communicating with patients with breast cancer about sexual health concerns (7 items), which are rated on an 11-point scale (0 = not at all confident/not at all; 10 = extremely confident/very much). Mean scores across all items on these scales were used, and the internal reliability was excellent (Cronbach α ≥0.90).
Comfort
Comfort with discussing sexual health concerns was assessed using 7 items (eg, asking the patient about any sexual concerns, discussing the patient’s loss of sexual interest or desire) adapted from items used in other communication studies with cancer clinicians34 using expert input and formative research on this topic.21 Responses were rated on an 11-point scale (0 = not at all comfortable; 10 = extremely comfortable). Mean scores across the 7 items were used in analyses and the items had excellent reliability (Cronbach α = 0.95).
Analytic Plan
Data analysis was conducted using SPSS Statistics, version 24 (IBM Corp), using descriptive analyses to summarize the feasibility and acceptability of the intervention. Open-ended responses were analyzed using thematic analysis, with responses grouped with others based on thematic similarity into key lessons learned categories, and those categories subsumed under more comprehensive themes. A primary coder conducted the first round of coding (J.B. Reese) and a second coder (S.L. Bober) reviewed these codes, with consensus achieved through discussion. As per recent recommendations,35 preliminary outcome data were analyzed descriptively, with 95% confidence intervals calculated to summarize the data at the 2 assessments. A sample size of 30 clinicians completing the study was determined a priori to be adequate to achieve study objectives; this sample size was chosen to maximize the chance of correctly determining feasibility and acceptability (ie, maximize the chance of true-positive results and minimize the chance of false-positive results).
Results
Participants
Characteristics are presented for the 30 clinicians who completed the study. Of these clinicians, 20 (67%) were medical oncologists, 7 (23%) were nurse practitioners, and 3 (10%) were physician assistants. The mean [SD] age of participants was 42.5 [10.0] years (range, 24–61 years). Most clinicians (n=22; 73%) identified as White, 6 (20%) identified as Asian/Southeast Asian, 1 (3%) identified as Black, and 1 (3%) identified as other; 3 clinicians (10%) identified as Hispanic/Latino. A total of 22 clinicians (73%) identified as female. Regarding years in practice, 9 (30%) had ≤5 years, 7 (23%) had 6 to 10 years, 6 (20%) had between 11 and 15 years, and 8 (27%) had >15 years.
Feasibility
Enrollment took place between February and October 2020. Of the 70 clinicians approached to participate, 33 completed the eligibility screen, whereas the remainder did not respond to the invitation (Figure 1). All 33 who completed the eligibility screen were eligible to participate in the study, and 32 consented. Of these, 30 listened to both episodes and completed the postintervention study survey. Rates of enrollment (46% of those invited; 97% of those screened eligible), intervention completion (94%), and study completion (94%) passed the preset feasibility benchmarks for the study. The mean length of time taken to complete the study (ie, listen to both episodes and complete all study surveys) was nearly 2 weeks (mean [SD], 13.6 [16.8] days), with most participants (87%) completing the study within 3 weeks and 4 completing it in 1 day.
Study flow diagram.
Citation: Journal of the National Comprehensive Cancer Network 19, 10; 10.6004/jnccn.2021.7032
Acceptability
Acceptability data are shown in Table 2. Of the 30 participants who completed the study, 24 (80%) endorsed the acceptability items, exceeding the preset benchmark suggestive of acceptability of the intervention. Most clinicians reported that the intervention was highly relevant, informative, and easy to use, as well as being satisfied and likely to recommend it to a colleague. Most also endorsed that the intervention would likely change their practice.
Clinicians’ Evaluations of the Intervention Acceptability (N=30)
Intervention Effects
Means and confidence intervals for clinicians’ baseline and postintervention scores on outcome measures are shown in Table 3. Preliminary findings show notable increases, with the means and 95% confidence intervals being uniformly in the positive range. For instance, knowledge scores increased: clinicians responded correctly to an average of 8 items postintervention compared with 6 at baseline. Scores for beliefs (self-efficacy, outcome expectancies) and comfort with discussing sexual health concerns were high at baseline, especially for outcome expectancies. However, increases were nevertheless seen for all these measures, with the highest point increase being for comfort.
Clinicians’ Baseline and Postintervention Scores on Outcome Measures
Summary of Lessons Learned
Results of the qualitative analysis of the postintervention survey item assessing clinicians’ lessons learned from the intervention, including relevant illustrative quotes representing each theme, are shown in Table 4. All 30 clinicians responded to this item. Five key themes of the qualitative analysis emerged reflecting overarching lessons learned. Theme 1 (Being Proactive in Discussing Sexual Issues: It’s My Responsibility) centered on the key idea that it is clinicians’ responsibility to broach the subject of sexual issues with their patients and that doing so gives patients permission to discuss the issue. These quotes emphasize the importance of proactively addressing this issue, rather than waiting for the patient to raise the topic.
Theme 2 (Normalize Discussions of Sexual Health) centered on the importance of assuring patients that sexual health is a normal topic and appropriate to discuss. Clinicians discussed strategies that could assure patients of this by informing patients of the nature of sexual concerns as highly common and treating sexual issues as just another aspect of health worthy of discussion.
Theme 3 (Knowing the Patients to Target) included the main ideas that all patients should receive a discussion of sexual issues, but then certain groups of patients, including those on aromatase inhibitors and ovarian suppression, require special care due to the severity and abruptness of sexual problems they often experience.
Theme 4 (Understanding How to Raise the Topic) included 3 main clinical skills for raising the topic of sexual concerns and continuing the conversation throughout the cancer trajectory.
Finally, Theme 5 (Understanding How to Respond to Sexual Concerns) included 2 key ideas, including the importance of conveying the message that options to address women’s sexual problems are available, and sharing specific information to address key common sexual concerns of vaginal dryness and discomfort during sex.
Qualitative Themes for Clinicians’ Lessons Learned From the iSHARE Intervention
Discussion
Results of this pilot study demonstrate the acceptability and feasibility of the iSHARE mLearning intervention delivered as an informational podcast series. Rates of participation (46% of all contacted; 97% of those responding and screening eligible) surpassed our feasibility benchmark and were comparable to other clinician communication intervention studies.36–38 These rates were noteworthy in light of the time commitment being asked of the clinicians (ie, 2 half-hour podcasts, 3 study surveys) and the fact that the bulk of enrollment occurred during the COVID-19 pandemic and the ensuing societal and professional changes experienced by many clinicians. Nevertheless, a number of clinicians contacted did not respond to our invitation to participate. Although we cannot infer reasons for nonresponse, moving forward it will be important to determine how digital interventions can best be promoted as viable alternatives to more resource-intensive in-person options. In addition, nearly all clinicians who consented completed the study, suggesting that they found the material appealing enough to finish. These findings add to a growing body of literature examining podcast interventions as having a unique role in medical education39,40 and suggest that the modality could hold appeal for clinicians even when competing demands on clinicians’ time and attention are substantial. Offering Continuing Medical Education (CME) credits and limiting the surveys administered to clinicians could further improve uptake, although this will need to be tested in future research. Determining how best to optimize uptake of evidence-based interventions to enhance clinical communication about sexual health concerns will be a critical step in this area of research.
The intervention was also well-received by clinicians, with high marks given for the informative, relevant content and convenient format. Moreover, relative to the traditional in-person format used in similar studies,18,37,41 these findings suggest that the mLearning approach used here is consistent with clinicians’ preferences, in that it is relatively brief, focused, and easily accessible.21 The one item of the program evaluation survey assessing acceptability that was less highly endorsed was the item assessing the likely impact on clinicians’ clinical practice. In the trial of this intervention in its previous iteration,18 clinicians similarly reported feeling unconvinced that the intervention would change their practice, even though an analysis of their communication during audio recorded clinic encounters suggested otherwise. Nevertheless, the findings supporting the acceptability of the intervention content and format bode well both for the success of a larger trial and for uptake in the larger population of clinicians.
Data from this pilot study suggest that this brief intervention may improve clinicians’ understanding of sexual problems among patients with breast cancer (eg, symptoms, solutions) and their comfort and confidence in clinical communication regarding sexual health concerns. Their perceived expectations for these discussions (ie, outcome expectancies) also showed a positive trend. Inadequate knowledge and skills can limit breast cancer clinicians’ discussions with their patients about sexual health concerns21; addressing these barriers could help chip away at this problem.42 Moreover, the takeaway messages clinicians cited for the intervention provide context to the empirical findings and suggest that clinicians gleaned a mix of both specific information and strategies and guiding principles for navigating discussions of sexual concerns throughout the breast cancer care trajectory. For instance, clinicians commented on learning about the importance of addressing sexual health concerns in all women with a breast cancer diagnosis and that they can build on the patient–provider relationship as a foundation for discussing these issues early and often. These points are consistent with recommendations from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Survivorship: Sexual Function11 and with patients’ wishes for such discussions.13,21
This study had several strengths. First, the mLearning intervention we tested is an innovative approach to addressing the lack of discussion regarding sexual concerns among women with breast cancer, which could potentially be disseminated more easily and with fewer resources compared with interventions using traditional trainer-based methods. Second, we used both quantitative and qualitative assessments to understand the impact of the intervention for clinicians and collected detailed information to understand feasibility and acceptability. Finally, the sample included both physicians and advanced practice clinicians, which could facilitate larger-scale testing in this population and bolster the generalizability of the intervention to a wide range of breast cancer clinicians.
To maintain consistency with the initial iSHARE intervention, the mLearning adaptation described here was tested in breast cancer clinicians in a medical oncology setting; however, surgeons and radiation oncologists could also benefit from evidence-based information on discussing sexual health concerns, and efforts should expand to include these groups. Future studies should also aim to include a more diverse sample of clinicians with respect to racial and ethnic background and consider how best to address differences in patient health literacy when discussing sexual health concerns. The study also had other limitations, including no assessment of clinicians’ communication about sexual health concerns, long-term follow-up, or control group. We are planning a larger trial that will address these concerns and evaluate intervention effects on clinicians’ communication behaviors through coding dialogue. Given that trials of online interventions in medical education have not always yielded consistent results,43 a well-designed trial will be critical. We also left the time frame for completing the study open so that clinicians could choose when to listen to the podcasts according to their availability and preferences. This may have helped bolster completion rates, but also created a range of time frames in which clinicians finished the study. In an efficacy trial, it will be important to set time limits on intervention use so that intervention effects can reliably be determined.
Conclusions
This mLearning (iSHARE) intervention holds promise as a tool to hasten patient–clinician communication about sexual health concerns among patients with breast cancer. Offering CMEs and using organizations such as the NCCN or ASCO could potentially enhance reach for this intervention.44 We hope that this study will help close the gap on patient–provider communication about sexual health concerns.
Acknowledgments
We wish to thank the breast cancer clinicians who participated in our research.
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