Mind-Body Intervention for Female GI Cancer Survivors

Overseen By Lucy Finkelstein-Fox, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Active psychiatric, cognitive comorbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mind-body group intervention designed to improve sexual well-being for female survivors of colorectal and anal cancer. It includes six weekly online sessions that focus on relaxation, mindfulness, and self-compassion, specifically tailored to support women's sexual health after cancer treatment. The trial gathers feedback on the program's usefulness and acceptability. Women who have completed initial cancer treatments at certain hospitals and are experiencing the effects of cancer survivorship may be suitable for this trial. As an unphased study, this trial provides a unique opportunity for participants to contribute to innovative research that could enhance the quality of life for many women.

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 prior data suggests that this intervention is safe 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. Studies indicate they can enhance sexual health and emotional well-being in cancer survivors. Serious side effects rarely occur with these treatments. Participants often find them helpful and comforting. The aim is to support overall wellness without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mind-Body Group Intervention for female GI cancer survivors because it offers a holistic approach that is different from the typical medical treatments focused on drugs or surgery. This intervention integrates relaxation techniques, mindfulness, and self-compassion specifically targeted at improving sexual well-being and overall quality of life, areas often neglected in standard care. Delivered through accessible videoconferencing, it provides support and education on sexual health in a group setting, potentially reducing feelings of isolation and stigma that survivors may experience. By addressing mental and emotional health alongside physical recovery, this method could enhance survivors' coping strategies and satisfaction with their bodies post-treatment.

What evidence suggests that this mind-body intervention is effective for female GI cancer survivors?

Research has shown that mind-body practices can improve sexual health and emotional well-being for women who have survived gastrointestinal (GI) cancer. These practices, which often include relaxation, mindfulness, and self-compassion, help participants feel more positive about their sexuality and manage emotional challenges. Studies suggest these methods can enhance satisfaction with sexuality and address issues like changes in body image and feelings of loneliness. In this trial, participants will engage in the Mind-Body Sexual Well-Being Group Intervention, a new program being tested. Similar programs have shown promise in helping cancer survivors return to their daily lives. Overall, growing evidence indicates that mind-body practices can benefit emotional and sexual health after cancer treatment. ^{2 3 4 6 7}

Who Is on the Research Team?

Lucy Finkelstein-Fox, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

I speak English.

I receive my cancer treatment at an MGH-CC site.

I am female.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-session mind-body group intervention delivered via videoconferencing

6 weeks

6 weekly group sessions (virtual)

Follow-up

Participants complete post-intervention surveys and qualitative exit interviews to assess feasibility, acceptability, and psychosocial outcomes

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mind-Body Group Intervention

Trial Overview The study tests a new mind-body group intervention designed to improve sexual well-being in female GI cancer survivors. Up to 20 participants will give feedback on the program's acceptability and perceived benefits, influencing future larger-scale trials.

How Is the Trial Designed?

Group I: Mind-Body Sexual Well-Being Group Intervention Experimental Treatment 1 Intervention

Participants in the mind-body sexual well-being group intervention arm will participate in 6 weekly group sessions, delivered via videoconferencing, following enrollment. Group sessions will include content related to mind-body medicine (e.g., relaxation, mindfulness, self-compassion) applied to sexual well-being as well as educational information related to women's sexual well-being in cancer survivorship. Before and after completing the group program, participants will also complete brief self-assessment questionnaires to measure topics including satisfaction with sexuality, coping, loneliness, concern about body image, and stigma.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Harvard Medical School (HMS and HSDM)

Collaborator

Trials

208

Recruited

1,421,000+

Published Research Related to This Trial

Among US women diagnosed with gynecological cancer, 38.2% reported using mind-body medicine in the past year, which is higher than the 28.8% usage rate in women without such a diagnosis, indicating a significant interest in complementary therapies among this group.

Spiritual meditation was the most commonly used mind-body modality, followed by yoga and progressive relaxation; however, the study highlights the need for randomized controlled trials to establish the clinical effectiveness of these practices for gynecological cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and predictors of mind-body medicine use among women diagnosed with gynecological cancer: Findings from the 2017 US National Health Interview Survey. Wong, CHL., Sundberg, T., Chung, VCH., et al.[2021]

A study involving 95 women with various cancer diagnoses showed that a self-hypnosis and self-care intervention significantly improved participants' quality of life, with 97.5% continuing to practice relaxation techniques after the program.

All components of the intervention, including group support and hypnosis exercises, were rated highly for their usefulness, indicating that a multicomponent approach may be effective in supporting cancer patients' self-care and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Group Intervention Combining Self-Hypnosis and Self-Care in Oncology: Implementation in Daily Life and Perceived Usefulness. Grégoire, C., Faymonville, ME., Vanhaudenhuyse, A., et al.[2023]

A 12-week online psychoeducational program significantly improved sexual function, sex-related distress, and mood in women cancer survivors, with benefits lasting up to six months after the program ended.

While men showed some improvement in intercourse satisfaction, their overall sexual desire did not significantly change, indicating a need for more tailored interventions for male survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Quantitative and Qualitative Methods to Evaluate an Online Psychoeducational Program for Sexual Difficulties in Colorectal and Gynecologic Cancer Survivors. Brotto, LA., Dunkley, CR., Breckon, E., et al.[2018]

The 'Mindful After Cancer' intervention, an 8-week virtual mindfulness-based program, was found to be feasible and acceptable for 22 breast and gynecologic cancer survivors, with participants attending an average of 6.8 sessions.

This program addresses sexual health concerns in cancer survivorship, showing promise in improving access to effective interventions for sexual dysfunction, which is often overlooked in post-cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Mindful After Cancer: Pilot Study of a Virtual Mindfulness-Based Intervention for Sexual Health in Cancer Survivorship. Gorman, JR., Drizin, JH., Smith, E., et al.[2023]

Mind-body interventions like hypnosis and imagery/relaxation have been shown to effectively control pain and reduce anxiety in cancer patients, enhancing their overall treatment experience.

Yoga and meditation are supported by randomized controlled trials for improving quality of life, mood, and sleep in cancer patients, highlighting the importance of these therapies in managing the emotional and physical challenges of cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body interventions in oncology. Carlson, LE., Bultz, BD.[2021]

The i-ReBIC online group therapy intervention was found to be feasible and well-accepted by participants, with 93% satisfaction reported among the 60 women who enrolled, and 47 completing the 8-week program.

Participants showed statistically significant improvements in body image distress and experience of embodiment after the intervention, indicating that i-ReBIC effectively addresses body image concerns for women post-cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of i-Restoring Body Image after Cancer (i-ReBIC): A pilot trial for female cancer survivors. Trachtenberg, L., Wong, J., Rennie, H., et al.[2020]

The ReBIC intervention, an 8-week group therapy program for breast cancer survivors, significantly improved body image concerns and quality of life compared to standard care, with benefits lasting for at least one year.

While the intervention effectively reduced distress related to body appearance and stigma, it did not show a significant impact on sexual functioning, indicating a need for additional support in that area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial. Esplen, MJ., Wong, J., Warner, E., et al.[2019]

A pilot study involving 27 gynecologic cancer patients showed that a 12-week web-based support group focusing on sexuality-related topics was both feasible and well-accepted, providing significant emotional support and improved body image.

Participants reported benefits such as increased emotional well-being and comfort in discussing sensitive topics, highlighting the effectiveness of online support groups in addressing psychosexual distress among gynecologic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study of an internet-based support group for women with sexual distress due to gynecologic cancer. Wiljer, D., Urowitz, S., Barbera, L., et al.[2022]

A psycho-educational group intervention for 203 women with breast cancer significantly reduced anxiety, anger, depression, and fatigue, while improving emotional functioning and interpersonal relationships after an 8-week program.

The intervention was well-received with high satisfaction levels and no negative effects reported, suggesting it could be a valuable complement to existing individual psycho-oncologic therapies in France.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a psycho-educational group after early-stage breast cancer treatment: results of a randomized French study. Dolbeault, S., Cayrou, S., Brédart, A., et al.[2022]

A nurse-led sexual rehabilitation program for women who have survived gynaecological cancer was implemented in a randomized controlled trial with 172 participants, aiming to improve sexual functioning, reduce sexual distress, and enhance marital satisfaction.

The program is designed based on established sexual health frameworks and will assess its effectiveness through various measures at multiple time points, contributing valuable insights into nursing interventions for sexual health post-cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse-led sexual rehabilitation programme for rebuilding sexuality and intimacy after treatment for gynaecological cancer: Study protocol for a randomized controlled trial. Chow, KM., Porter-Steele, J., Siu, KY., et al.[2022]

In a study involving 105 adult cancer survivors, participation in the SMART-3RP program led to significant improvements in resiliency, mindfulness, and positive affect, with effect sizes ranging from moderate to large (ds = 1.01-0.46).

The increase in resiliency was most strongly linked to improvements in mindfulness and positive emotions, suggesting that these factors are crucial for enhancing the psychological well-being of cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing psychosocial mediators of a mind-body resiliency intervention for cancer survivors. Finkelstein-Fox, L., Rasmussen, AW., Hall, DL., et al.[2022]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-05089

A Mind-Body Sexual Well-Being Intervention for Female ... This clinical trial identifies essential components of an integrative mind-body sexual well-being intervention that is being designed to support the needs ...

2. withpower.com withpower.com/trial/phase-colorectal-neoplasms-3-2024-de163

Mind-Body Intervention for Female GI Cancer Survivors The available research shows that Mind-Body Intervention for Female GI Cancer Survivors is effective in improving sexual health and emotional well-being. For ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10986786/

Psychosocial interventions that target adult cancer ... This review identified 6 types of interventions to reintegrate survivors back into their daily lives following cancer treatment.

4. mdpi.com mdpi.com/2227-9032/12/2/253

Promoting Sexual Health in Colorectal Cancer Patients ... This systematic review aimed to identify and summarize the efficacy of available psychological interventions aimed at improving colorectal cancer patients' and ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S146238891400043X

A feasibility study of a psychoeducational intervention ... This study aimed to test the feasibility of implementing a psychoeducational intervention program for gynecological cancer patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06331403

Open Pilot Trial of a Mind-Body Sexual Well-Being ... This is an open pilot trial to gather initial data regarding feasibility, acceptability, and perceived impact of a 6-session mind-body group intervention that ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06307470?cond=ovarian+cancer&aggFilters=status%3A%2Cphase%3A

Nurse-led Mind-body Intervention on Sexual Health for ... A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.