This record describes two distinct study phases: 1) A small open pilot trial including up to 10 participants, intended to generate descriptive feedback on regarding perceived benefits and areas for improvement for a group-based mind-body sexual well-being program for women treated for colorectal and anal cancers and 2) A pilot randomized controlled trial (RCT) including up to 100 participants, intended to provide information about feasibility, acceptability, and preliminary efficacy of the group-based mind-body sexual well-being program compared to enhanced usual care control (EUCC). Given the early-stage, open-pilot nature of the first study phase, which is not intended to produce interpretable results for feasibility, acceptability, or efficacy, this record will only report results from the second study phase (pilot RCT).
The primary objective of this protocol is to iteratively refine and pilot test a novel mind-body sexual well-being intervention that investigators 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 the investigators 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 investigators further refine the sexual well-being program for the next phase of the study, investigators 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, investigators 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, investigators 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. Investigators 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, investigators 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 the 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
Weekly virtual group meetings with the study interventionist(s) and up to 9 other female cancer survivors over an approximately 6 week period. The group program includes topics related to coping with physical health changes, managing social factors relevant to sexual well-being, and managing thoughts and feelings related to sexual well-being changes.
Participants randomized to EUCC will not receive any components of the mind-body group intervention. After randomization, the study CRC will offer participants a handout listing information about sexual health resources currently available to them that they may choose to access. Participants in the EUCC condition will also have the option of seeking care through the cancer center's local sexual health program, as is the current standard of care.
Mass General Brigham Cancer Institute
Boston, Massachusetts, United States
Feasibility of Intervention
To explore feasibility, investigators will use descriptive statistics (i.e., frequency and percentages) to evaluate the proportion of enrolled participants who completed at least 66%, or 4/6, of the scheduled intervention sessions (\>/= 70% as our cutoff criteria for feasibility).
Time frame: Approximately 6 weeks after the final 6-week group program begins
Acceptability of Intervention
To establish acceptability, we will examine the % of participants scoring at or above the scale midpoint on the CSQ-8 (\>/= 70% as criteria for acceptability).
Time frame: Approximately 6 weeks following group program start
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.