Mind-Body Program for Female GI Cancer Survivors

LF
Overseen ByLucy Finkelstein-Fox, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a mind-body program designed to support sexual well-being in women treated for colorectal or anal cancer. The researchers aim to determine if the Mind-Body Group Intervention can improve sexual health and relationships compared to standard care. Participants will either attend group sessions focused on relaxation and mindfulness or receive educational resources about sexual health. This trial suits women who completed active cancer treatment at least three months ago and are experiencing distressing changes in their sexual health or intimate relationships. As an unphased trial, it provides a unique opportunity to explore innovative approaches to enhance sexual well-being.

What prior data suggests that this mind-body program is safe for female GI cancer survivors?

Research has shown that mind-body treatments are generally safe and easy to manage. These methods often emphasize relaxation, mindfulness, and self-kindness. Studies have found that cancer patients tolerate mind-body exercises well, and these exercises can enhance emotional health. Most participants in these studies reported improvements in pain, fatigue, anxiety, mood, sleep, and overall well-being. These findings suggest that the mind-body group intervention is safe for participants and may offer additional emotional benefits.12345

Why are researchers excited about this trial?

Researchers are excited about this mind-body program because it offers a holistic approach to improving sexual well-being for female GI cancer survivors, which isn't a focus of most existing treatments. Unlike standard care that often emphasizes medical or pharmacological interventions, this program uses mind-body techniques like relaxation, mindfulness, and self-compassion, applied specifically to enhance sexual health and overall well-being. Delivered through accessible videoconferencing, it combines educational content with emotional and psychological support, aiming to empower survivors in a unique and comprehensive way.

What evidence suggests that the mind-body group intervention could be effective for female GI cancer survivors?

Research has shown that mind-body activities can enhance the quality of life for cancer survivors. Studies have found that these therapies reduce anxiety, depression, and stress. In this trial, participants in the Mind-Body Sexual Well-Being Group Intervention arm will engage in a program focused on sexual well-being, potentially improving sexual health for women who have survived colorectal and anal cancer. Evidence from past participants in similar programs showed significant improvements in their well-being. Mind-body exercises are generally considered safe and somewhat effective for managing symptoms in cancer survivors.46789

Who Is on the Research Team?

LF

Lucy Finkelstein-Fox, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for women who have been treated for colorectal or anal cancer and are experiencing sexual health concerns. Participants must be adults and able to join group sessions. Those with serious mental health issues or unable to participate in group activities may not be eligible.

Inclusion Criteria

Able to speak and read English
Receive any cancer care at any MGH-CC site (Boston, Waltham, Danvers, Newton Wellesley Hospital)
Access to an internet-connected device with video
See 4 more

Exclusion Criteria

Participated in an earlier phase of the study (DF-HCC protocols #22-586, #24-009, #24-281)
Prisoners
Participation in Phase 1 of this protocol excludes eligibility for Phase 2
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open Pilot Trial

Participants complete electronic informed consent and attend approximately 6 weeks of group-based sessions focusing on mind-body medicine and complementary medical resources for sexual well-being.

6 weeks
6 weekly group sessions (90 minutes each, virtual)

Randomized Pilot Trial

Participants are randomized into mind-body intervention groups or enhanced usual care control (EUCC). Mind-body group participants attend a 6-week program similar to the open pilot trial.

6 weeks
6 weekly group sessions (virtual)

Follow-up

Participants complete survey batteries at 3-month post-intervention to capture symptom change over a longer period.

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Mind-Body Group Intervention

Trial Overview

The study compares a mind-body group program designed to improve sexual well-being with enhanced usual care (standard support plus extra resources). Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mind-Body Sexual Well-Being Group InterventionExperimental Treatment1 Intervention
Group II: Enhanced Usual Care Control (EUCC)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

American Cancer Society, Inc.

Collaborator

Trials
237
Recruited
110,000+

Citations

Effects of Mind-Body Exercise in Cancer Survivors - PMC - NIH

The current evidence demonstrates that mind-body exercise is relatively safe and modestly effective for symptom management in cancer survivors.

Mind-Body Therapies for Cancer Survivors

Discover how integrative therapies, acupuncture and meditation, may reduce pain and stress and improve quality of life in cancer survivors.

Mind-Body Interventions for People With Cancer: Evidence, ...

Mindfulness-based interventions have become accepted into mainstream cancer care, supported by two decades of evidence demonstrating their effectiveness in ...

Pubs - IO with Mindfulness -Linda Carlson

A Phenomenological Qualitative Exploration of Mind-Body Therapy Use and Effectiveness Among Young, Middle, and Older Adult Cancer Survivors. Integrative Cancer ...

A Mind-Body Sexual Well-Being Intervention for Female ...

A mind-body sexual well-being intervention may enhance women's sexual well-being in colorectal and anal cancer survivorship. Eligibility Criteria ...

Mind-Body Intervention for Female GI Cancer Survivors

Research has shown that mind-body treatments are generally safe and easy to manage. These methods focus on relaxation, mindfulness, and self-kindness.

Comparative effects of different types of mind-body ...

Mind-body exercise appears safe and potentially beneficial for emotional health in cancer patients. Findings should be interpreted cautiously due to low ...

Mind–body exercise for symptom management in cancer - PMC

The results suggested that mind–body exercise compared with the control group significantly demonstrated reduction in the anxiety levels [SMD = −0.39, 95 ...

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

6-week, group-based, mind-body sexual well-being program for female survivors of colorectal and anal cancer. intervention feasibility and ...