Mind-Body Intervention for Female GI Cancer Survivors
Trial Summary
What is the purpose of this trial?
The primary goal of this protocol is to conduct an open pilot to collect initial quantitative and qualitative feedback on the intervention that the investigators are developing. To do so, the investigators will deliver a newly-developed intervention to up to 2 consecutive groups of female colorectal and anal cancer survivors (n = up to 10 per group, total N = up to 20). Participants will provide feedback regarding intervention acceptability, feasibility, and perceived benefit. To inform plans for ongoing program refinement, the investigators will elicit specific feedback about study assessment tools, recruitment procedures, and group factors. Given the early-stage, open pilot nature of this protocol, the investigators will not set strict criteria to establish feasibility and acceptability but will rather interpret each of these outcomes holistically. Qualitative feedback collected in post-intervention exit interviews will also support understanding of feasibility and acceptability. As a secondary aim, the investigators will explore the preliminary effects of the intervention on psychosocial measures of satisfaction with sexuality and impact of functional limitations, coping abilities, acceptance of body image changes, loneliness, and anticipated stigma. As noted above, the investigators will not set specific criteria to establish preliminary efficacy, nor will they consider statistical significance as an indicator of the study's efficacy for these outcomes. Instead, the investigators will consider pre-post intervention effect sizes to consider the need for refinement of study procedures/measurement in a future larger trial. In future, larger-scale, work, the investigators intend to conduct a larger randomized pilot trial to assess intervention acceptability, feasibility, as well as preliminary efficacy on essential outcomes related to sexual well-being.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.
What data supports the idea that Mind-Body Intervention for Female GI Cancer Survivors is an effective treatment?
The available research shows that Mind-Body Intervention for Female GI Cancer Survivors is effective in improving sexual health and emotional well-being. For example, a study on an online psychoeducational program for colorectal and gynecologic cancer survivors found that women experienced significant improvements in sex-related distress. Another study on an internet-based support group for women with gynecologic cancer reported benefits such as increased emotional well-being and improved feelings of body image and sexuality. These findings suggest that Mind-Body Interventions can help address sexual difficulties and enhance quality of life for female cancer survivors.12345
What safety data exists for mind-body interventions in female GI cancer survivors?
The studies provided do not directly address safety data for mind-body interventions specifically in female GI cancer survivors. However, they suggest that mind-body interventions, such as psychoeducational programs, self-hypnosis, and mindfulness-based interventions, are generally well-received and considered useful by participants, with no specific safety concerns reported. These interventions are aimed at improving quality of life and addressing sexual health issues in cancer survivors, indicating a positive reception and perceived benefit among participants.16789
Is the Mind-Body Group Intervention a promising treatment for female GI cancer survivors?
Yes, the Mind-Body Group Intervention is promising for female GI cancer survivors. Research shows that mindfulness and psychoeducational programs can improve sexual health and quality of life for cancer survivors. These interventions help reduce stress, improve mood, and enhance overall well-being.1891011
Research Team
Lucy Finkelstein-Fox, PhD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
This trial is for English-speaking women, aged 18 or older, who have completed initial treatment for colorectal or anal cancer at least 3 months prior. They must have received their cancer care from specific sites associated with MGH-CC in locations like Boston and Danvers.Inclusion Criteria
Treatment Details
Interventions
- Mind-Body Group Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Harvard Medical School (HMS and HSDM)
Collaborator