6 Participants Needed

Mind-Body Intervention 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)

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

LF

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

I am female.
I speak English.
I am 18 years old or older.
See 2 more

Treatment Details

Interventions

  • Mind-Body Group Intervention
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Mind-Body Sexual Well-Being Group InterventionExperimental Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Integrating Quantitative and Qualitative Methods to Evaluate an Online Psychoeducational Program for Sexual Difficulties in Colorectal and Gynecologic Cancer Survivors. [2018]
Feasibility and acceptability of i-Restoring Body Image after Cancer (i-ReBIC): A pilot trial for female cancer survivors. [2020]
Testing psychosocial mediators of a mind-body resiliency intervention for cancer survivors. [2022]
Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial. [2019]
A qualitative study of an internet-based support group for women with sexual distress due to gynecologic cancer. [2022]
Prevalence and predictors of mind-body medicine use among women diagnosed with gynecological cancer: Findings from the 2017 US National Health Interview Survey. [2021]
The effectiveness of a psycho-educational group after early-stage breast cancer treatment: results of a randomized French study. [2022]
A Group Intervention Combining Self-Hypnosis and Self-Care in Oncology: Implementation in Daily Life and Perceived Usefulness. [2023]
Feasibility of Mindful After Cancer: Pilot Study of a Virtual Mindfulness-Based Intervention for Sexual Health in Cancer Survivorship. [2023]
A nurse-led sexual rehabilitation programme for rebuilding sexuality and intimacy after treatment for gynaecological cancer: Study protocol for a randomized controlled trial. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Mind-body interventions in oncology. [2021]