NCT04559854

Brief Summary

The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

September 11, 2020

Results QC Date

February 8, 2024

Last Update Submit

June 6, 2025

Conditions

Breast CancerGynecologic Cancer

Outcome Measures

Primary Outcomes (4)

  • Feasibility/ Enrollment in the Study

    Percentage of participants enrolled of those eligible

    Baseline (T1)

  • Feasibility/ Retention in the Study

    Number and percentage of participants completing all assessments

    1 month post-intervention (T2)

  • Feasibility/ Retention in the Intervention

    Number and percentage attending at least 6 of 8 sessions

    1 month post-intervention (T2)

  • Acceptability of the Intervention

    Endorsement of 10 items characterizing acceptability of the intervention (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability.

    1 month post-intervention (T2)

Secondary Outcomes (10)

  • Change From Baseline Interest in Sexual Activity at 1 Month

    Baseline (T1) and 1 month post-intervention (T2)

  • Change From Baseline Satisfaction With Sex Life at 1 Month

    Baseline (T1) and 1 month post-intervention (T2)

  • Change From Baseline Self-efficacy at 1 Month

    Baseline (T1) and 1 month post-intervention (T2)

  • Change From Baseline Body Image at 1 Month

    Baseline (T1) and 1 month post-intervention (T2)

  • Change From Baseline Body Appreciation at 1 Month

    Baseline (T1) and 1 month post-intervention (T2)

  • +5 more secondary outcomes

Study Arms (1)

Mindful After Cancer

EXPERIMENTAL

Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.

Behavioral: Mindful After Cancer

Interventions

Mindful After CancerBEHAVIORAL

The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions.

Mindful After Cancer

Eligibility Criteria

Age18 Years - 89 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of breast or gynecologic cancer at least one year prior to enrollment
  • Completed primary cancer treatment
  • English speaking
  • Have access to a computer, smart phone, or tablet with internet access
  • Ability to spend 15-30 minutes per day on program activities

You may not qualify if:

  • \- Stage 0 (carcinoma in situ)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Jessica Gorman
Organization
Oregon State University
Jessica.Gorman@oregonstate.edu
541-737-2323

Study Officials

  • Jessica R Gorman, PhD, MPH

    Oregon State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 23, 2020

Study Start

July 1, 2019

Primary Completion

October 1, 2020

Study Completion

October 5, 2020

Last Updated

June 25, 2025

Results First Posted

June 25, 2025

Record last verified: 2025-06

Locations

US(1)