Virtual Mindful After Cancer (MAC) Intervention to Promote Sexual Health for Breast and Gynecologic Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindful After Cancer Program.
- Who it may be relevant to
- Registry conditions: Gynecologic Cancers, Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Virtual Mindful After Cancer Intervention to Promote Sexual Health for Breast and Gynecologic Cancer Survivors
Overview
The goal of this study is to plan for a large scale evaluation of a program called Mindful After Cancer, or MAC. The MAC Program provides training in mindfulness, educational material about sexual health after cancer, and support to cancer survivors experiencing sexual and body image concerns. The main study aims are to: 1. Develop effective plans for recruiting participants across multiple sites 2. Evaluate participation in the program and surveys 3. Develop plans to train and supervise the professionals who will deliver the program. Researchers will compare study recruitment across three sites, aiming to identify the most efficient approach for a larger future trial. Participants who are randomly assigned to receive the MAC program will receive access to the 8-week program delivered by a trained mindfulness coach using videoconference and online materials. They will asked to participate in an interview about their experiences at the end of the program. Participants who are not randomly assigned to the MAC program will receive access to the program's educational materials after completing the final survey. All study participants will be asked to complete 3 online surveys. Participants randomly assigned to the MAC Program will also be asked to complete a one-on-one interview about their experience in the program.
Interventions
- Behavioral Mindful After Cancer Program
The Mindful After Cancer Program provides education, mindfulness training, and peer support to help cancer survivors navigate sexual and body image concerns.
Primary outcome measures
- Recruitment Accrual Rate- The percent of eligible candidates who enroll [Time frame: Baseline]
- Intervention Fidelity- The percent of required topics covered during intervention sessions as measured by completion of a checklist. [Time frame: Up to 1 week post-intervention.]
- Retention Rate - The percent of enrolled participants who complete all study surveys [Time frame: Up to the 3 month post-intervention survey at week 22.]
Secondary outcome measures (1)
- MAC intervention Drop Out- As measured by session attendance. [Time frame: Up to completion of the 8-week MAC intervention.]
Eligibility criteria
Inclusion criteria
- At least 18 years old
- Diagnosed with female breast or gynecologic cancer at stage I-IV
- Diagnosed at least 6 months ago
- At least one sexual concern in a validated screener
- Access to high speed internet via smart phone, tablet, and/or computer
Exclusion criteria
- Those who do not comprehend English since the MAC program is only available in English.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- Samaritan Pastega Regional Cancer Center — Corvallis
- University of Pennsylvania — Philadelphia
- Fox Chase Cancer Center — Philadelphia
Identifiers
NCT: NCT07055854 · HE-2023-492 · 1R34CA286710