Initial Development of a Brief Mind-Body Sexual Well-Being Program for Female Colorectal and Anal Cancer Survivors: A Two-Phase Study of Survivor Needs and Treatment Preferences

Abstract

Background

Many female colorectal and anal cancer survivors experience distressing changes to sexual well-being (e.g., dyspareunia, low libido) after treatment. Though mind-body programming has previously shown benefit for women’s sexual well-being, no existing program is available to address women’s sexual well-being specifically following colorectal and anal cancer treatment.

Objective

This two-phase study describes initial development of a group mind-body program for women’s sexual well-being in colorectal and anal cancer survivorship.

Methods

Phase 1 includes individual interviews with 18 female colorectal and anal cancer survivors and 8 clinicians at an academic comprehensive cancer center, focusing on intervention priorities and session content. In Phase 2, female colorectal and anal cancer survivors from the same cancer center participated in an open pilot trial of the group sexual well-being program (6 weeks; 2 groups with 6 participants in total). Qualitative and quantitative feedback regarding preliminary feasibility and acceptability were interpreted holistically to inform next steps for intervention refinement.

Results

In Phase 1, patients identified priorities for intervention, clarified interest in mind-body practices, and highlighted key program modifications (e.g., addressing ostomy use, prioritizing patient privacy in groups). Clinicians expressed positive feedback on the proposed intervention and noted key areas of unmet need for the patients they serve. In Phase 2, preliminary program feasibility (100% of those enrolled attending at least 4 of 6 sessions) and acceptability (83.3% rating their comfort level in groups ≥ 4 on a 5-point scale) were supported. Average group cohesiveness across 6 valid items was high (M = 4.6, range 3.8-5.0).

Conclusion

There is clear need for specialized sexual well-being programming for female colorectal and anal cancer survivors. The initial iteration of this mind-body group program was well-received by participants with several key areas for improvement identified that will inform iterative refinement of this novel group intervention.

Introduction

Lower gastrointestinal (GI) cancers, including colorectal and anal cancer, are among the most common malignancies experienced by women in the United States (US).^1,2 Following recent estimates, nearly 80,000 women in the US receive a new diagnosis of colorectal or anal cancer each year, resulting in a very high proportion of survivors living for years with the long-term side-effects of treatments such as surgery, radiation, and chemotherapy.^1,2 These effects can include diarrhea, incontinence, infertility, sexual dysfunction, and temporary or permanent stoma and colostomy bag.^3,4 Women also often experience dyspareunia and vaginal dryness following treatment, which may persist for many years if not treated. These symptoms can lead to psychological impacts, including decrements to body image, libido, and intimate relationships.^3,5,6 However, these concerns are typically not assessed by clinicians and there is a lack of intervention resources targeting female survivors’ sexual well-being following treatment.^7-9

Supportive mind-body programming, including elements of psychoeducation, mindfulness, self-compassion, cognitive-restructuring, relaxation, and gentle movement, demonstrates promise for female cancer survivors’ sexual well-being,^10-13 but these resources have rarely been applied to the specific needs of women who have completed lower GI cancer treatment. Previous trials, most often focused on the needs of breast^13-16 and gynecologic^10,11,17 cancer survivors, demonstrate that interventions including aspects of mindfulness, relaxation, and mind-body coping skills along with psychoeducation focused on sexual rehabilitation are feasible, acceptable, and efficacious for enhancing female survivors’ sexual well-being. Unfortunately, few interventions have been tailored to the needs of women treated for colorectal and/or anal cancers, which are unique in their impact on severe digestive symptoms, risk for body image difficulties, and potential psychosocial stigma surrounding symptoms such as diarrhea, incontinence, and need for colostomy use.^8,18

The few existing psychosocial sexual well-being interventions that have been developed to specifically address the needs of female colorectal or anal cancer survivors^19-22 suggest that programming may be well-received, though the literature remains limited by focus on co-habiting heterosexual partnered dyads,^19,22 individual delivery rather than a more cost-effective group format^19,21,22 and asynchronous delivery, ²⁰ limiting the benefits of learning from real-time interaction with peers and/or a group facilitator. No previous trials have leveraged a synchronous, video-enabled group format for delivery of sexual well-being content; Brotto and colleagues provided participants access to an anonymous discussion board, though received qualitative feedback that participants did not regularly use the discussion board option and would have preferred opportunities for live peer interaction. ²⁰ Further, each of trials was completed several years ago, which limits the relevance of program content to current social norms around women’s sexuality that provide an important cultural context to participants’ decisions around sexual health behavior engagement. ²³

The present report thus describes the initial development phases of a novel group-based mind-body program developed specifically to meet the needs of female survivors of colorectal and anal cancers, regardless of partnership status or current level of sexual activity.

The research reported here comprised two separate phases of foundational intervention development (Phases 1 and 2), both of which will inform ongoing program refinement. The objective of Phase 1 was to gather initial qualitative feedback from patients and clinicians, collected via individual interviews, about their perceived priorities for intervention design. These qualitative data were used to directly inform design of the study intervention, which incorporated tools from mind-body medicine, sexual health education, cognitive-behavioral therapy, and positive psychology.

After initial intervention design concluded in Phase 1, the objective of Phase 2 was to conduct an initial open pilot trial of the newly developed clinical protocol to gain additional feedback from participating patients regarding the protocol’s anticipated feasibility and acceptability for women who had recently completed colorectal and anal cancer treatment. Our primary criterion for feasibility was an average of 4 or more of the 6 scheduled sessions completed and our primary criterion for acceptability was participant ratings of comfort with the group program as ≥ 4 on a 5-point Likert scale. Group comfort was selected as the primary index of acceptability because of the importance of evaluating whether group-based programming would be an appropriate means of addressing sensitive sexual health concerns for this group, given the novelty of this format for individuals with colorectal and anal cancer. Additional acceptability items were intended to be interpreted together with this primary item; qualitative data were also used to elicit greater detail and nuance to these brief quantitative ratings. Given the preliminary, open pilot nature of the protocol we did not set a priori cutoffs for feasibility and acceptability but rather treated these as exploratory outcomes. Group cohesiveness is also included in the present report as a secondary exploratory outcome, informing the overarching research goal of designing a program that would leverage the benefits of perceived connection and peer support around a potentially sensitive topic such as sexual well-being in cancer survivorship. In future work, findings from the open pilot will be interpreted holistically and applied to ongoing intervention refinement and testing.

Methods

Phase 1

Participants

Patients. Eligible patient participants for Phase 1 (individual qualitative interviews) were female, English-speaking adult (age ≥ 18) patients who had received cancer care at any Massachusetts General Hospital (MGH) Cancer Center location and had completed initial active treatment (e.g., radiation, surgery, chemotherapy) for cancer of the colon, rectum, and/or anus three months or more prior to study start. Though participants were informed that the research study was designed to address the needs of women experiencing sexual health concerns following completion of cancer treatment and were asked whether they would like to participate in such a study, no standardized cut-off for severity of current sexual health concerns was used. This decision was informed by the National Comprehensive Cancer Network (NCCN) Survivorship Guidelines, which suggest that sexual health programming should be offered to all survivors. ²⁴ Individuals who, based on the clinical judgment of the study investigators, were unable to provide informed consent due to cognitive, medical, or psychological limitations were excluded from participation. Eighteen patients meeting the inclusion criteria above provided informed consent and completed individual qualitative interviews. To capture a full spectrum of experiences with sexuality in survivorship, purposive sampling was used to intentionally recruit approximately equal numbers of women older and younger than age 50.

Clinicians. Eligible clinicians were those with a current MGH, Dana Farber-Harvard Cancer Center (DF-HCC), or Harvard Medical School (HMS) affiliation who had expertise in colorectal and/or anal cancer, integrative medicine, gynecology, and/or sexual health, including clinicians with varied training backgrounds. Eight clinicians meeting these criteria provided informed consent and completed individual qualitative interviews.

Procedure

All study procedures were approved by the Dana Farber-Harvard Cancer Center (DF-HCC) Institutional Review Board (IRB) under protocol #22-586.

Patients. For this early-phase project, purposive sampling was used to identify patients whose perspectives would be relevant to the experiences of individuals who would likely be enrolled in later phases of intervention development efforts within the DF-HCC setting. Specifically, recruitment of eligible patients was accomplished through three possible pathways: 1) clinician referral, 2) direct patient-initiated outreach in response to a study flyer, or 3) research staff screening of relevant clinicians’ electronic clinic logs followed by a request to an oncology clinician for permission to reach out to the patient (i.e., confirming likely eligibility and clinical appropriateness of the patient’s participation). In the case of direct referrals from clinicians, study staff performed an initial screening of relevant information in the patient’s electronic health record to confirm likely eligibility (e.g., confirming presence of colon, rectal, or anal cancer diagnosis with initial treatment completed at least 3 months prior). Three months post-treatment was selected as the most appropriate lower limit for patient participation in this study based on clinical insight that this may be the timepoint at which patients might be interested in engaging with sexual health programming after processing the end of treatment. Once study staff confirmed via chart review that patients were likely to be eligible to participate and received confirmation of clinical appropriateness to approach, a trained clinical research coordinator (CRC) called patients via phone directly to share information about the study, determine interest, and conduct a formal eligibility screening for interested participants.

After confirming study eligibility via phone screening, all patient participants who indicated interest in enrolling completed a verbal informed consent procedure with the study CRC. Of 31 patients directly contacted about study participation, 19 provided initial informed consent to participate (1 of whom withdrew prior to completing a study interview). Of those who were contacted and did not provide informed consent to participate, 9 did not respond to outreach attempts and 3 declined after speaking to the study CRC (1 due to time constraints, 2 did not provide a reason). After completing informed consent procedures, patient participants scheduled an individual meeting with the study interviewer either via Zoom (n = 5) or telephone (n =13), based on patient preference.

All interviews were audio-recorded, with patient permission. At the start of each interview, the interviewer asked patients a series of relevant sociodemographic questions and asked them to self-report the type of lower GI cancer with which they had been diagnosed (see Table 2), with responses entered directly into a REDCap survey. The semi-structured interview guide for patients focused on personal definitions of sexual well-being in survivorship, preferences for what an appropriate sexual well-being intervention might include, anticipated level of interest in participating in a mind-body sexual well-being program, possible barriers and facilitators to engaging in sexual well-being intervention, comfort discussing sexual well-being with others, and perceived appropriateness of mind-body strategies for sexual well-being in survivorship. The interview guide was formulated based on holistic models of positive resiliency after stress exposure ²⁵ and women’s sexual well-being.^26-33 After completing the study interview, patient participants were mailed a $25 gift card as a token of gratitude for their time.

Table 2.

Participant Characteristics in Phase 1

​	Range, median or N(%)
Age (years)	37-75, median 59.5
Sex – female	18 (100%)
Gender – female/woman	18 (100%)
Race
White	17 (94.4%)
Asian	1 (5.6%)
Hispanic/Latinx Ethnicity (yes)	1 (5.6%)
Relationship Status
Single and dating one or more people	1 (5.6%)
Married	9 (50.0%)
Long-term relationship with one or more people	4 (22.2%)
Not partnered	4 (22.2%)
Highest Level of Education
Less than Bachelor’s degree	5 (27.8%)
Bachelor’s degree	8 (44.4%)
Graduate/professional school	5 (27.8%)
Employment Status
Employed full-time	10 (55.6%)
Employed part-time	3 (16.7%)
Retired	4 (22.2%)
On disability or medical leave	1 (5.6%)
Cancer Type
Anal	8 (44.4%)
Rectal	5 (27.8%)
Colon	2 (11.1%)
Multiple sites (colon, rectal, and/or anal)	3 (16.7%)

Clinicians. Recruitment of eligible clinicians was accomplished via direct email outreach to the study investigators’ professional networks. Given the broad eligibility criteria for clinicians, no formal eligibility screening was necessary prior to scheduling of interviews. Of 9 clinicians directly contacted with an invitation to participate in the study, 8 agreed to do so. All 8 clinicians completed individual study interviews via Zoom.

All clinician participants completed a verbal informed consent procedure with the study interviewer, a licensed clinical psychologist, before beginning the study interview and provided permission for the interview to be audio-recorded. A brief semi-structured interview guide for clinicians was designed to build on findings from patient interviews, eliciting feedback on patients’ identified priorities for sexual well-being programming, perceived unmet needs for sexual well-being programming and current practices for addressing patients’ concerns, and possible barriers to connecting patients with such programming. In contrast to the interviews conducted with patients, clinicians were presented with a detailed outline of the proposed mind-body group program being developed by the study team and were asked to comment specifically on the appropriateness of the planned content addressing patient concerns.

Data Analysis

Audio interviews were transcribed to text with identifiers removed. Following best-practice guidelines,^34,35 deductive methods within a rapid analysis coding framework were used to interpret qualitative data. Initial overarching codes were identified by the study team to organize participant responses, based on theories of cancer-related sexual health concerns, ²⁶ barriers to communication about sexuality and cancer,^29,30 and key mind-body intervention components for survivorship sexual well-being and resiliency.^25-28,31-33 After reaching initial consensus on the initial rapid qualitative coding matrix for data reduction, one primary reviewer coded participant-level data into this matrix using full interview transcripts. The primary coder met at least weekly with lead study staff to discuss emerging themes in the study data, which were in turn used to revise the coding matrix as necessary. After the initial coding process, codes were then reviewed with the larger study team to identify clinical implications and appropriate revisions of the study manual.

Phase 2

Participants

Patient eligibility criteria for the open pilot trial were almost identical to those reported for Phase 1 above, with the addition of greater specificity that eligible patients were those who had completed active treatment for colon, rectal, or anal cancer three months or more prior to study start or those who had been diagnosed with metastatic disease at least three months ago. This change was made based on feedback from referring clinicians that many patients living with metastatic disease may be eager to participate despite continuing to receive active treatment with palliative intent. Two cohorts of participants were invited to enroll in a group program, each designed to enroll no more than 10 individuals based on standard clinical practices for psychologically oriented group intervention. A total of 6 patients meeting the inclusion criteria above provided informed consent and participated in one of two 6-week open pilot group programs (see Figure 1 for CONSORT diagram). After enrollment in the first open pilot group was complete, eligibility criteria were further updated for the second open pilot group to clarify that participants enrolled in Phase 1 of the study would be excluded from Phase 2.

Figure 1.

CONSORT diagram for open pilot trial

Procedure

All study procedures were approved by the DF-HCC IRB under protocol #24-009. The open pilot trial was registered on ClinicalTrials.gov (NCT06331403) before beginning participant recruitment.

Recruitment procedures were identical to those described above for Phase 1 (i.e., via clinician referral, direct patient outreach in response to a study flyer, or proactive electronic health record screening). As for Phase 1, a trained CRC called potentially eligible patients via phone directly to share information about the study, determine interest, and conduct a formal eligibility screening for interested participants. All eligible patients were directed to provide informed consent via an electronic form embedded in REDCap, which they completed via phone with the study CRC. After completing the e-consent process, participants were emailed a REDCap link to complete a baseline survey, including items related to sociodemographics, medical history, and psychosocial functioning. Of 23 patients directly contacted about study participation, 6 provided informed consent to participate (see Figure 1 for full study CONSORT).

Ninety-minute intervention groups including 2-4 participants were held weekly for a total of 6 weeks. After the final group meeting was completed, participants were emailed a survey link to complete follow-up measures in REDCap and were invited to schedule an approximately 30-minute exit interview with a member of the study team. Interviews queried topics such as feedback on specific program content, perceived benefit or shortcomings of the program, and logistical or practical barriers to participation. Patients also provided feedback on topics such as the ideal timing of study participation during the cancer survivorship trajectory and appropriateness of receiving content in a group format. Participants received up to $60 in gift cards as a token of gratitude for their participation in the open pilot trial ($20 each for completed baseline survey, follow-up survey, and qualitative exit interview).

Program Content

Based on feedback from Phase 1, the group program comprised 6 weekly 90-minute sessions, each of which was focused on a different concept related to women’s sexual well-being and colorectal/anal cancer survivorship (see Table 1). Aligned with the weekly concept, each session included psychoeducational content, review of a relevant mind-body resource (including in-session experiential practice), and discussion of cognitive-behavioral tools for enhancing sexual well-being. Sessions were co-facilitated by a licensed clinical psychologist and doctoral-level oncology nurse practitioner with specialized training in mind-body approaches to stress management and sexual health. Each group began with an opportunity for participants to check-in on barriers/facilitators to progress with their goals and ended with a review of tools and exercises for self-guided practice.

Table 1.

Overview of Initial Intervention Structure

Topic discussed	Sexual well-being target
1. Defining Stress and Sexual Sequelae of Treatment	Uncertainty about “normal” sexual health changes following cancer treatment; stress-sexuality connection and rationale for mind-body tools
2. Social Factors & Women’s Sexual Well-Being in Context	Stigma and shame; barriers to communication about sexual health concerns that limit access to social support
3. Awareness of Thoughts and Feelings	Unhelpful stress-related thoughts about sexuality; ways that stress-related thoughts may detract from pleasant experience
4. Body Image Changes	Difficult thoughts and feelings related to body image post-treatment; difficulty enjoying physical experience or engaging in self-care
5. Meditative Movement	Pain/tightness and changes to physical sensation; exploring pleasant physical experience and activity planning
6. Meaning-Making of Change	Personal values and goals for sexuality/intimacy; review of resources and relapse prevention

Measures

Sociodemographics and Medical History

Patients completed a brief electronic questionnaire querying similar sociodemographic and medical information as in Phase 1 (see Table 3). An additional item querying sexual orientation was also included for Phase 2. Patients self-reported the type of cancer with which they had been diagnosed.

Table 3.

Participant Characteristics in Phase 2

​	Range, median or N(%)
Age (years)	50-73, median 55.0
Female Gender	6 (100.0%)
Sexual orientation - straight	6 (100.0%)
Race
White	6 (100.0%)
Relationship Status
Married or living as married	5 (83.3%)
Not partnered	1 (16.7%)
Cancer Type
Anal	3 (50.0%)
Rectal	1 (16.7%)
Colon	2 (33.3%)

Program Acceptability

Program acceptability was assessed using 5 items designed by the study team, administered at follow-up only. We elected to use an original brief measure of acceptability, in comparison to a standardized acceptability/satisfaction questionnaire, to gather precise, population-specific information that would inform intervention design. Acceptability items used in the present study were adapted from items developed for other trials led by our group ³⁶ to specifically fit the needs of this initial pilot of a sexual well-being intervention for female cancer survivors. Items assessed: 1) comfort in group sessions, 2) satisfaction with virtual format, 3) satisfaction with facilitator, 4) likelihood of recommending this program to others, and 5) difficulty of survey completion via REDCap. Items were tailored by the study team to assess comfort in group sessions, to evaluate the acceptability of discussing sensitive topics in a virtual group format; satisfaction with virtual delivery, which may represent a change from traditional in-person format but expand reach of the novel program; satisfaction with facilitator, which might inform selection of a psychologically-trained versus other (e.g., patient advocate) facilitator; likelihood of recommending to others, which might provide general information about whether patients thought the group was useful for its stated objectives; and satisfaction with online survey format, which might inform changes to how sexual and psychological well-being were assessed for the study (e.g., in person at clinic or via remote electronic survey). The response scale for each item was “not at all (1), not very (2), somewhat (3), very (4), and extremely (5).” Ratings for each item were considered separately, with item 1 (comfort in group sessions) considered as our primary index of acceptability. Group comfort was selected as the primary index of acceptability because of the central importance of evaluating whether group-based programming would be an appropriate means of addressing sensitive sexual health concerns for this group. The four other items were intended to be interpreted together with this primary item, and qualitative data was used to elicit greater detail and nuance regarding participant perceptions of group acceptability. We also explored an average acceptability rating for each participant, across all 5 items. Because patient perceptions of program content were queried in-depth as part of post-program exit interviews (e.g., aspects of the program that were most or least helpful), the study survey did not ask specifically for ratings of satisfaction with program content.

Group Cohesiveness

Given the sensitive nature of the group topic, perceived cohesiveness among the 6-week group program participants was assessed using the 7-item Group Cohesiveness Scale. ³⁷ Group cohesiveness was assessed at follow-up only. The response scale was “strongly disagree (1), disagree (2), neutral (3), agree (4), strongly agree (5).” Upon close examination of the seven items of the GCS-7 scale, one item (“The members appeared to do things the way they thought would be acceptable to the group”) was excluded from further analysis due to inconsistent performance with the other scale items. Ratings for each of the remaining six items were considered separately. We also explored an average acceptability rating for each participant, calculated across all 6 valid items.

Data Analysis

Given the very small sample size included in our initial open pilot trial, we report only basic descriptive statistics (i.e., measures of central tendency [mean, median], dispersion [range, SD, 95% CI], and proportion above an a priori feasibility/acceptability definition to characterize participants’ experience in the group program, as this sample was not designed to be adequately powered to detect reliable estimates of pre-post change in clinical outcomes. ³⁸ Qualitative data were analyzed by two coders using a rapid analysis framework,^34,35 with regular weekly consultation supervised by a lead study investigator to refine codes and emerging themes. As for Phase 1, an initial deductive coding matrix was developed by the team based on a priori research questions regarding participant reactions to study outreach and participation, preferences for program content, virtual delivery, and assessment of sexual well-being. A senior qualitative expert was consulted to resolve discrepancies in study coding.

Results

Phase 1

Patient Characteristics

As is explicated in Table 2, patient participants completing study interviews were mostly White, non-Hispanic women in a current partnered relationship. One third (33.3%) was aged 50 or younger. Approximately half had been treated for anal cancer, with smaller numbers diagnosed with rectal and colon cancer.

Qualitative Program Feedback - Patients

Values and priorities for sexual well-being

Patients of all ages described ability to engage in sexual activity, particularly intercourse, as central to their own sexual well-being and ability to establish or maintain valued intimate relationships. For example, one participant noted that her personal definition of sexual health included “being able to be intimate with somebody sexually… it’s that added closeness in a relationship.” To follow, many acknowledged current primary goals of being able to re-engage in penetrative sex, which may not be immediately possible in the context of untreated vaginal stenosis, dryness, and pain following cancer treatment. The emotional impact of physical changes to sexual function was often substantial; as described by one partnered participant, “there was a mourning period that we had to go through…sexual intercourse is not the same as it was.”

In addition to several participants’ focus on ability to have partnered intercourse, other women specifically named current goals of enhancing libido, adjusting to changes in body image, and learning how to manage menopause-related symptoms that interfere with enjoyment of sexuality (e.g., vaginal dryness, hot flashes, and changes to sleep/fatigue). Finally, management of reproductive health and prevention of STIs (i.e., HPV) were named as important for holistic sexual well-being.

Perceived need and priorities for sexual well-being intervention

Most participants endorsed interest in pursuing a mind-body sexual well-being program specific to the needs of female colorectal and anal cancer survivors, as described to them by the interviewer, reflecting that they would like to receive additional support managing this under-addressed aspect of life.

Participants valued receiving content broadly related to: 1) education about the impact of cancer treatments on sexual well-being and what symptoms to expect – both prior to treatment and over the course of post-treatment recovery; 2) social support and understanding around the emotional impact of sexual well-being symptoms; 3) strategies for general stress management in survivorship and 4) specific self-regulation/rehabilitative strategies for managing concerning sexual health changes (e.g., “I just would like to hear how other people are dealing with this because maybe there’s something they’re doing that would be helpful to me.”) Though participants generally agreed that post-treatment completion would be an appropriate time to engage with a supportive group sexual well-being intervention, preference for initial sexual well-being intervention ranged from immediately upon diagnosis (i.e., when information about what to expect in the future could be communicated) to a few months after completing treatment (i.e., when women might have the emotional bandwidth to focus on sexual health symptoms). As described by one participant, learning about possible sexual health symptoms early on in treatment might help survivors prepare themselves for what to expect later on: “the girls I talked to on social media were like, “I didn’t know this was a possibility and could potentially happen after my treatment until s**t already hit the fan and I had all these problems...”… they’re just overwhelmed.”

Potential limitations to participation and suggested modifications

Common hesitations to participating in a group-based mind-body sexual well-being program included concerns about 1) privacy and willingness to share information; 2) wanting to distance themselves from cancer after completing treatment; 3) time commitment and 4) applicability of content. Participants noted concerns about privacy and willingness to share personal information in a Zoom-based group, particularly given the stigma associated with sex, cancer, ostomy use, and digestion/voiding symptoms (e.g., “I’m not a person that likes to share that type of information with others.”) To address possible privacy concerns, participants emphasized the importance of letting prospective group members know what to expect ahead of time, training an experienced and compassionate facilitator who would be able to direct the group dynamic, and explicitly discussing rules around confidentiality among group participants early on.

Separate from concerns about privacy, participants also highlighted the possibility that recent cancer survivors might prefer to distance themselves from upsetting cancer-related information after the stress of completing treatment (e.g., “I’m happy, my husband is happy, I just want to forget it.”) Several participants noted that the time commitment required to regularly attend groups might make it difficult to participate, particularly for those with other commitments or ongoing fatigue following treatment. One participant reflected that the program content would need to feel immediately applicable to her own current goals in order to make the time investment feel worthwhile: “I would really need to know right off the bat, ‘is this something I’m going to be able to incorporate to benefit my sexual health?’”

Finally, given the unique clinical needs of female colorectal and anal cancer survivors, participants advised that an integrative mind-body sexual well-being program would be best received if the study team modified any program exercises to be gentle and appropriate for individuals with physical limitations or severe digestive symptoms (e.g., ostomy). Still, many noted that exercises including meditation, yoga, and other types of modified physical activity were already part of their daily well-being routine and might be beneficial to offer to others. As one woman described, “I look at health as a patchwork of tools that I need in order to have general physical, emotional, mental, and spiritual health…I really need them all…I think that helping people who don’t have skills in mindfulness or meditation is definitely helpful.”

Qualitative Program Feedback - Clinicians

Barriers to discussing sexual well-being

Echoing the feedback shared by patients, clinicians uniformly perceived sexual well-being as an important, under-addressed topic for survivors. They described several barriers to fully addressing patient’s sexual well-being concerns in current clinical practice, including a need to focus on urgent medical aspects of cancer treatment during brief appointments, concern about social dynamics (e.g., presence of other people in the room during busy appointments and difficulty knowing how to respond should patients bring up complex concerns), and uncertainty about available referral resources and patient access to care.

Emotional adjustment tools

Of note, some clinicians reflected that topics such as libido and emotional distress around intimacy changes felt more challenging for them to address in a brief medical appointment, compared to functional issues such as vaginal stenosis, dryness, or pain. As such, when reviewing the proposed mind-body group content for the present study, they emphasized that patients might especially benefit from tools to help them cope with emotional adjustment to a “new normal” of intimacy as well as educational information about female sexual anatomy and menopause symptoms. As articulated by one clinician, “Helping them with goals, the female sexual response info…as well as talking to them about the general stressors in their life is often a missing piece. That’s where I wish all of them had more support.” Most interviewees were eager to consider the proposed mind-body program as an additional referral option for their current clinical practice and would be comfortable offering it to a large proportion of their patients. In the context of brief medical appointments and sometimes in frequent follow-up appointments that make it difficult to discuss sexual health concerns in-depth, some clinicians suggested that the study team might develop a brief resource (e.g., handout or website) about the group program that could be easily shared with patients.

Phase 2

A CONSORT diagram describing study enrollment and flow for the open pilot trial (Phase 2) is in Figure 1 above.

Participant Characteristics

As shown in Table 3, program participants were all White, non-Hispanic, heterosexual women. Most participants were in a current partnered relationship and half were diagnosed with anal cancer.

Program Feasibility

Study flow is detailed in the CONSORT diagram (Figure 1).

Recruitment

Of 35 individuals reviewed for program eligibility (identified either via direct clinician referral or proactive chart review), 23 (65.7%) were determined to be potentially eligible for the program and appropriate to contact for initial screening and were thus contacted via phone to complete an initial assessment of interest and eligibility to participate in the 6-week program. Of the 12 individual cases reviewed but not contacted for further screening, most (n = 9; 75%) were excluded due to apparently inappropriate timing of treatment/diagnosis. Three additional individuals (25%) were not approached for further screening based on clinician guidance regarding appropriateness of participation.

Screening and Eligibility

Of the 23 individuals contacted via phone, 6 (26.1%) were determined to be eligible and enrolled in the study; of the remaining 17 individuals who did not proceed to enroll after initial phone outreach, 3 (13.0%) were not reachable after a total of 3 outreach attempts, 4 (17.4%) responded to an initial outreach attempt, requested that the study team re-contact them, and did not respond to subsequent follow-up, 7 (30.4%) declined to participate after learning more about the study, and 3 (13.0%) expressed interest in participating after learning more about the study but were unable to attend the groups at the time offered.

Program Attendance

Of the 6 individuals who enrolled in the program, 100% completed 4 or more of the 6 scheduled sessions per our primary criterion for feasibility (M = 5.2 sessions completed, SD = 0.75, range = 4-6). None withdrew early from the program.

Data Collection

Of the 6 individuals enrolled in the program, 100% completed post-program surveys. Five (83.3%) completed optional post-program exit interviews.

In qualitative exit interviews, participants highlighted that they felt it was helpful to participate in groups a few months after completing initial cancer treatment, at which point they would be motivated to focus on symptom management rather than survival. Notably, those who had been in post-treatment survivorship for several years would have preferred to receive the program content earlier in their survivorship trajectory. Participants named several factors that had motivated them to engage in the group program, including a desire to develop new coping skills for sexual health and connect with others who had shared experience, but also an altruistic goal of helping other survivors to improve this valued part of life (“Maybe this can help at least some other people to talk about it and maybe heal…faster than I am doing.”) Participants varied in the extent to which logistical or practical barriers precluded engagement with the groups, with some noting that conflicting life events made it difficult to attend weekly sessions.

Adverse Events

While enrolled in the mind-body program, two participants (33.3%) each experienced an instance of short-term, unexpected, mild abdominal discomfort that was determined to be not serious and unrelated to their participation in the study. No serious adverse events occurred over the course of the trial.

Program Acceptability

Most (83.3%) participants rated comfort in group sessions, our primary metric of acceptability, as high (≥4 on a 1-5 scale). Average acceptability across all 5 items assessed was also high (M = 4.6, SD = 0.34; range 4.0 – 5.0). Descriptive statistics for individual items are listed in Table 4.

Table 4.

Descriptive Statistics for Program Acceptability Items

Item	Mean (SD), range	% ≥ 4 on 1-5 scale
1. How comfortable were you in the group sessions?	M = 4.3 (SD = 0.82), range = 3-5	83.3%
2. How satisfied were you with the virtual format? (i.e., participating in groups via Zoom)	M = 4.5 (SD = 0.55), range = 4-5	100%
3. How satisfied were you with the way the program facilitator led the group sessions?	M = 4.8 (SD = 0.41), range = 4-5	100%
4. How likely are you to recommend this program to other women experiencing sexual health changes after cancer treatment?	M = 4.7 (SD = 0.82), range = 3-5	83.3%
5. How difficult was it for you to complete study surveys electronically? (reverse coded)	M = 4.5 (SD = 0.84), range = 3-5	83.3%
Average across all items	M = 4.6 (SD = 0.34), range = 4.0-5.0	100%

In qualitative exit interviews, participants shared that several factors contributed to high acceptability of the groups, including: 1) a sense of support and sense of shared experience/understanding from other group members; 2) knowing what to expect in each weekly group meeting; 3) enjoyment of a weekly check-in point to maintain accountability to one’s personal sexual well-being goals; and 4) inclusion of participants with varied treatment experiences (e.g., time since cancer treatment, experience addressing sexual health concerns) who could voice their unique perspectives. One participant shared, “Realizing how many other women across the age continuum are on the same journey is very helpful.”

Group Cohesiveness

Average group cohesiveness as assessed across 6 valid items assessed was 4.6 (range 3.8-5.0). Descriptive statistics for each item are listed in Table 5.

Table 5.

Descriptive Statistics for Group Cohesiveness Scale Items

Item	Mean (SD), range	% ≥ 4 on 1-5 scale
1. I felt accepted by the group	M = 4.8 (SD = 0.41), range = 4-5	100%
2. In my group we trusted each other	M = 4.7 (SD = 0.52), range = 4-5	100%
3. The members in my group liked and cared about each other	M = 4.5 (SD = 0.84), range = 3-5	83.3%
4. The members tried to understand why they do they things they do; tried to reason it out	M = 4.7 (SD = 0.52), range = 4-5	100%
5. The members felt a sense of participation	M = 4.5 (SD = 0.55), range = 4-5	100%
6. The members revealed sensitive personal information or feelings	M = 4.5 (SD = 0.55), range = 4-5	100%
Average across all items	M = 4.6 (SD = 0.48), range = 3.8 – 5.0	83.3%

In qualitative exit interviews, participants articulated gratitude for the candor of other group members in sharing their challenging experiences and noted that it would have been nice to have a larger group with greater representation of women with diversity of relationship status, age, and experience with cancer. Some reflected that the group format provided a helpful space for practicing communication around sensitive topics, with one noting her appreciation for “how brave the ladies were… their attitude encouraged me to think about myself and, you know, ask for help if I need. It was really impressive ... how other ladies can talk about this sensitive issue.” However, some also reflected that participant differences in cultural background and life stage may have negatively impacted individual comfort with sharing sensitive information in the group setting. When asked for feedback on ways that the group makeup might be altered in future iterations of the program (e.g., moving towards a couples-based intervention approach), participants posited that including romantic partners in the meetings would be logistically challenging and take away from the self-care focus of the groups.

Feedback on Specific Study Content

With regard to participants’ specific feedback on session content, exit interviews highlighted an appreciation of the program’s balanced content between medical information and mind-body tools such as breathing and mindfulness. Participants who had pre-existing mind-body practice noted that it was helpful to focus on the specific application of mindfulness tools to sexual well-being, rather than their use for general stress management. Participants had varied perspectives on the extent to which a greater emphasis on medical versus mind-body information would be ideal in figure program iterations. On one hand, certain participants found the mind-body information to resonate more strongly with their own needs; a participant who particularly enjoyed the mind-body content shared that she was “trying to shed [external stresses]… I’m trying to focus more on what I’m doing.” In contrast, another participant expressed desire for primary focus on medical content, reflecting that she might not have participated if she had known that mind-body content would be so heavily emphasized during the group meetings: “I’ve done a lot of training in that and have a lot in my toolbox. So for me, that section of it was not as meaningful as real, down and dirty, hands-on, what you can do to enhance your sexual life post-treatment.”

When asked about specific aspects of the program that they continued to use in their daily lives, participants cited continual use of mind-body practices such as body-focused visualization practice, targeted relaxation techniques, and mindful breathing. Though some participants noted increased confidence in their ability to talk about sexuality with others (e.g., partners, medical providers), whereas others described that improving communication with friends or medical providers remained a goal for them due to limited opportunities for practice over the six-week program (e.g., infrequent medical appointments) or lingering intense emotions around sexuality and cancer that they hoped to address further.

Discussion

Results of this two-phase study suggest that a group-based mind-body program may be developed to directly address concerns related to sexual well-being in cancer survivorship for women treated for colorectal and/or anal cancer. Participant feedback emphasized the need for educational content specifically focused on sexuality in cancer survivorship and further highlighted the benefits of offering this content in a group format, which provided an opportunity to build connection with others and practice discussing sensitive topics. In a small initial open pilot trial of the novel group intervention, participants described improvements in their ability to understand and address sexual health concerns that are common among female survivors of colorectal and anal cancer. Though the sample size completing this initial iteration of the program was too small to generate interpretable data regarding clinical effect sizes or statistical significance of study improvements, several important directions for future program refinement and testing emerged from these initial results.

First, the data presented here highlight a clear need for direct, specific discussion of sexuality, including basic education about sexual function and what to expect during/after cancer treatment (e.g., early initiation of dilator use and timeline of recovery). Mind-body practices such as deep breathing, mindfulness, and guided imagery were well-received by participants in both study phases, many of whom had prior exposure to these practices; however, specific guidance is needed to demonstrate how these can be directly applied to sexual well-being and intimacy (e.g., managing challenging thoughts and feelings around body changes; tolerating invasive treatments such as pelvic floor physical therapy or dilator use). In future work to refine this program, it may be useful to further assess participants’ pre-existing knowledge of mind-body practice prior to the start of the intervention and provide directive guidance in program handouts regarding when and how these tools could be applied directly to sexual well-being or intimacy. Though we did not provide participants with audio-recordings of mind-body practices introduced during group meetings, this may also be an important technique for facilitating home practice in future iterations of these groups.

Social factors emerged as important to participants’ experience of the proposed group program. In post-program exit interviews with our small open pilot sample, participants highlighted the benefits of enrolling women with various types of cancer/life experience and shared that they would have enjoyed being in a larger group that provided greater opportunity to learn from others. This aligns with the feedback reported from a previous individually-delivered sexual well-being trial, in which participants voiced a preference to socialize with other survivors in a group setting. ²⁰ Though our study sample size was too small to draw definitive conclusions about subgroups that might benefit most from receiving the tailored program content together (e.g., groups of only younger women, women with/without ostomy, women with/without current sexual relationships), this may be an important area to consider in future work. Based on exit interview feedback following our open pilot trial, future iterations of this program may also be enhanced by incorporating structured opportunities to practice communication skills around discussing sexuality (e.g., role-playing of example scenarios or directions for behavioral exposure practice between-session).

Despite the enthusiasm expressed by patients and clinicians in the present study, several barriers exist to offering sexual health programming that must be considered in designing similar programs. Patients participating in Phase 1 of the study highlighted stigma and concerns about privacy, as well as a possible preference to emotionally distance oneself from cancer-related information, as likely barriers to survivors engaging in the type of sexual health program that is described here. Feasibility data gathered in the Phase 2 open pilot trial further suggest that a minority of cancer survivors who are contacted proactively and offered a 6-session sexual health program may agree to participate, but those who do enroll exhibit strong engagement and report several benefits to doing so. This may reflect a reality that some patients experiencing sexual health changes prefer not to seek out treatment, whereas others experience distress resulting from sexual symptom change and are motivated to engage in a supportive intervention to address these concerns. Many participants were not reachable during our initial outreach calls and difficulties with scheduling and time commitment for this synchronous group-based program were often cited as barriers among those who were reached. As this low rate of enrollment may be an artifact of our attempts to proactively contact participants who may not be actively engaged with cancer treatment and may not have previously discussed sexual well-being with their medical team, it may be fruitful for future recruitment efforts to leverage face-to-face methods (e.g., warm hand-off during routine cancer follow-up appointments) in addition to the primarily phone-based outreach used in the present trial as this may allow patients to more easily ask questions of study staff in-real time. By learning about the possibility of study participation as part of a regular clinic appointment, participants may experience reduced burden (i.e., need to follow-up on research phone calls) and increased confidence in the integrated role of the study team within the hospital setting. It may also be interesting for future work to consider timing recruitment of all participants around a pre-defined event (e.g., at 6 months following completion of initial active treatment).

Interestingly, clinicians in Phase 1 noted that individuals with underlying emotional distress or difficulties with libido might be most in need of additional follow-up for sexual well-being, as compared to individuals with primarily physical health concerns (e.g., pain, dryness) that could be more straightforwardly addressed during a brief medical appointment. However, among the six women enrolling in our open pilot trial, desire to gain medical information about what to expect following treatment completion as well as coping skills for sexual well-being difficulties were noted as strong motivators for participation. Participants also voiced an eagerness to support other women with this challenging topic and to contribute to research that might improve the lives of others. This desire to make meaning out of a challenging life experience by supporting others who have similar experience highlights another important aspect of the social dynamic created by these groups.

Limitations and Future Directions

It should be noted that the initial intervention development efforts describe here are limited by a lack of diversity in patient race/ethnicity, sexual orientation, gender identity, socioeconomic background and partnership status. Despite our efforts to include women with varied life experience and illness-related concerns, the current iteration of this mind-body program best reflects the preferences of White, non-Hispanic, cis-gender, heterosexual, partnered women. Moving forward, it will also be essential to modify eligibility criteria and recruitment strategies to prioritize inclusion of women of color, women with diverse sexual orientation and gender identities, women with more limited socioeconomic resources, and those who are not currently in partnered sexual relationships. It should also be noted that participants were recruited from a large academic hospital in the northeastern United States, where social norms and institutional messaging around women’s sexuality may differ from norms in other parts of the world. Indeed, colorectal and anal cancer patients at MGH have access to brief nurse-delivered sexual health consultations, emphasizing use of moisturizers, lubricants, and vaginal dilators as part of standard care for patients receiving radiation treatment^39-41 and may thus have entered this program with some pre-existing knowledge about how cancer impacts sexual health. Though this foundational intervention development study relied on purposive sampling to characterize the experience of women with experiences in this specific, highly resourced, setting, it will be essential for later phases of intervention development to evaluate questions of generalizability and implementation. Relatedly, the small sample size included for Phase 2 (N = 6), well below the upper limit of N = 20 allotted for in the trial preregistration, allowed for in-depth understanding each participant’s experience in the program, but also underscores the importance of interpreting these findings as part of preliminary intervention refinement, rather than allowing for a formal test of feasibility and/or acceptability. Our purposive recruitment strategy relied on inherently subjective clinical judgments from the study investigators and collaborating oncology clinicians regarding the appropriateness of each patient’s participation, which limits the generalizability of these findings to a broader sample of women who may experience significant comorbid medical or psychiatric concerns as well as cancer-related sexual health changes; this remains a target for later-stage intervention testing efforts. Finally, we did not collect detailed health record data regarding pre-cancer menopausal status, precise tumor location, cancer staging, diagnostics, or treatment course for patients for this preliminary study in order to prevent undue burden due to need for a detailed HIPAA authorization during the brief informed consent process. In future work, it will be important for investigators to consider the impact of clinical variables beyond diagnosis type on patient preferences for intervention as well as response to a brief mind-body program. With a larger sample size, these data may also be useful together with information about sexual health symptom severity for identifying subgroups of women who stand to benefit the most from this type of intervention.

Taken together, results of the present study illustrate the necessity of incorporating feedback from patient and clinician stakeholders to develop an engaging, informative mind-body program to address survivorship well-being, an unmet need in women’s survivorship care. As the population of cancer survivors continues to grow, ⁴² it will be increasingly important to have brief, cost-effective, disseminable programs such as this one that allow women to engage with sexuality and intimate relationships in personally meaningful ways, despite common cancer-related side effects.

ORCID iDs

Lucy Finkelstein-Fox https://orcid.org/0000-0001-7799-9164

Isabelle L. Miranda https://orcid.org/0009-0004-0466-9235

Elyse R. Park https://orcid.org/0000-0002-6319-264X