Mind-Body Sexual Well-Being Program for Female GI Cancer Survivors

The primary objective of this protocol is to iteratively refine and pilot test a novel mind-body sexual well-being intervention that we have developed in previous research (DF-HCC protocols #22-586, #24-009, and #24-281). This protocol will include 2 study phases, including a small open pilot trial (Phase 1) and a subsequent larger randomized pilot trial (Phase 2). This protocol builds on previous work conducted by our research team to develop a 6-week, group-based, mind-body sexual well-being program for female survivors of colorectal and anal cancer.

For Phase 1 (Open Pilot Trial), participants will complete electronic informed consent (including HIPAA authorization for access to relevant medical information in the EHR) prior to initiation of study procedures. Participants will then be invited to attend approximately 6 weeks of group-based sessions, lasting for approximately 90 minutes and including content related to mind-body medicine and complementary medical resources relevant to survivors' sexual well-being. To help us further refine the sexual well-being program for the next phase of the study, we will ask participants to complete brief (approximately 30 minute) survey batteries via REDCap at baseline and after the 6-session program, including assessments of intervention feasibility and acceptability as well as relevant psychosocial outcomes.

For Phase 2 (Randomized Pilot Trial), participants will complete electronic informed consent (including HIPAA authorization for access to relevant medical information in the EHR) prior to initiation of study procedures. Participants will then be randomized into groups (mind-body intervention groups vs. enhanced usual care control (EUCC)).

Participants randomized to EUCC will not receive any components of the mind-body group intervention. As part of this condition, participants will receive the current standard of care for patients at MGH and additionally receive a standard resource sheet to ensure that all participants receive a basic level of information specific to sexuality in cancer survivorship. As part of routine study assessments, we will measure EUCC participants' level of engagement with the Sexual Health Clinic and other supportive resources.

Participants in the mind-body group intervention arm will receive the same educational information about available sexual health resources as the EUCC participants to ensure equal familiarity with supportive resources within and outside of MGH. Participants randomized to receive the mind-body group intervention will also participate in a similar approximately 6-week group-based mind-body sexual well-being program as is described for Aim 1.

Just as for Aim 1, to inform ongoing intervention refinement, we will ask all participants to complete brief (approximately 30 minute) survey batteries via REDCap at baseline and after the 6-session program, including items related to feasibility, acceptability, and relevant psychosocial outcomes. We will only randomize participants after receiving a completed baseline survey; participants who do not complete the baseline survey will not be counted towards the total number enrolled in the study. To capture symptom change over a longer period, we will also ask participants to complete survey batteries at 3-month post-intervention follow-up.

Approximately 20 participants randomized to receive the novel mind-body group study intervention will also be invited to complete a brief qualitative exit interview with a member of our study team, regarding perceived benefit of the intervention as well as and strengths and weaknesses of program content and delivery format to inform ongoing intervention refinement.

Inclusion criteria

• Female sex
• Able to speak and read English
• Aged 18 or older
• Receive any cancer care at any MGH-CC site (Boston, Waltham, Danvers, Newton Wellesley Hospital)
• Completed initial active treatment (i.e., surgery, radiation, chemotherapy) for colorectal or anal cancer approximately 3 months or more prior to enrollment (for curvivors/individuals treated for cancer with curative intent) or were diagnosed at least 3 months ago (for metavivors/individuals living with chronic cancer)
• Verbally endorse experiencing distressing changes to sexual health or intimate relationships, including changes that may be related to cancer diagnosis and treatment
• Access to an internet-connected device with video

Exclusion criteria

• Active psychiatric or cognitive comorbidity that prohibits the capacity to provide informed consent as determined by the study PI, a licensed psychologist, in collaboration with the patient's medical team
• Adults unable to complete study procedures in English
• Participated in an earlier phase of the study (DF-HCC protocols #22-586, #24-009, #24-281).

In addition, individuals who participate in Phase 1 of this protocol (open pilot trial) will not be eligible to participate in Phase 2 (pilot RCT). We will not enroll the following special populations: adults unable to consent, individuals who are not yet adults (i.e., < age 18), pregnant women, and prisoners.