Virtual Mindful After Cancer (MAC) Intervention to Promote Sexual Health for Breast and Gynecologic Cancer Survivors

Oregon State University (OSU)

Status and phase: Not yet enrolling; Phase 1

Conditions: Breast Cancer; Gynecologic Cancers

Treatments: Behavioral: Mindful After Cancer Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07055854

HE-2023-492

1R34CA286710 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Usual Care

No Intervention group

Intervention

Experimental group

Treatment:

Behavioral: Mindful After Cancer Program