NCT07055854

Brief Summary

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. 1.Develop effective plans for recruiting participants across multiple sites
  2. 2.Evaluate participation in the program and surveys
  3. 3.Develop plans to train and supervise the professionals who will deliver the program.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
11mo left

Started Aug 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Aug 2025May 2027

First Submitted

Initial submission to the registry

June 10, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

June 10, 2025

Last Update Submit

February 5, 2026

Conditions

Gynecologic CancersBreast Cancer

Keywords

cancer survivorshipmindfulnesssexual healthintervention

Outcome Measures

Primary Outcomes (3)

  • Recruitment Accrual Rate- The percent of eligible candidates who enroll

    Baseline

  • Intervention Fidelity- The percent of required topics covered during intervention sessions as measured by completion of a checklist.

    Adherence to the manual is assessed by independent review of audio-recorded intervention sessions using a checklist of material to be covered in each session.

    Up to 1 week post-intervention.

  • Retention Rate - The percent of enrolled participants who complete all study surveys

    Up to the 3 month post-intervention survey at week 22.

Secondary Outcomes (1)

  • MAC intervention Drop Out- As measured by session attendance.

    Up to completion of the 8-week MAC intervention.

Other Outcomes (16)

  • Exploratory outcome: Interest in sexual activity as measured by the interest in sexual activity domain from the PROMIS Sexual Function and Satisfaction Scale.

    Up to the 3 month post-intervention survey at week 22.

  • Exploratory Outcome: Body Appreciation as measured by the Body Appreciation Scale.

    Up to the 3 month post-intervention survey at week 22.

  • Exploratory Outcome: Sexual Satisfaction as measured by the Global Measure of Sexual Satisfaction scale (GMSEX).

    Up to the 3 month post-intervention survey at week 22.

  • +13 more other outcomes

Study Arms (2)

Usual Care

NO INTERVENTION

Intervention

EXPERIMENTAL
Behavioral: Mindful After Cancer Program

Interventions

Mindful After Cancer ProgramBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Those who do not comprehend English since the MAC program is only available in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Samaritan Pastega Regional Cancer Center

Corvallis, Oregon, 97330, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Jessica Gorman, PhD

CONTACT

541-737-2323Jessica.Gorman@oregonstate.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 10, 2025

First Posted

July 9, 2025

Study Start

August 25, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)