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

NCT ID: NCT07055854

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecologic Cancers Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Group Type EXPERIMENTAL

Mindful After Cancer Program

Intervention Type BEHAVIORAL

The Mindful After Cancer Program provides education, mindfulness training, and peer support to help cancer survivors navigate sexual and body image concerns.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Oregon State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samaritan Pastega Regional Cancer Center

Corvallis, Oregon, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Jessica Gorman, PhD

Role: CONTACT

541-737-2323

Facility Contacts

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Jonathan Wakefield

Role: primary

541-737-1064

Hannah Toneff

Role: primary

267-882-3186

Kristen Sorice

Role: primary

215-214-1433

Other Identifiers

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1R34CA286710

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HE-2023-492

Identifier Type: -

Identifier Source: org_study_id

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