NCT07610499

Brief Summary

To learn if the Creating Opportunities for Personal Empowerment (COPE) intervention is feasible, acceptable, and helpful (compared to usual care) in women with breast cancer who are receiving first line treatment.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
30mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

May 20, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

October 30, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 20, 2026

Last Update Submit

May 20, 2026

Conditions

COPEBreast CancerFirst Line TherapyRandomized Controlled Trial (RCT)

Outcome Measures

Primary Outcomes (1)

  • Patient-Reported Outcomes Measurement Questionnaire

    Through study completion; an average of 1 year

Study Arms (2)

COPE Intervention

EXPERIMENTAL

There are seven sessions within the COPE intervention. Sessions will be facilitated by a research team member weekly over the course of seven weeks and each session will take approximately 45 minutes.

Other: Intervention sessions

Control Group

OTHER

Usual care will consist of standard care provided by the participant's healthcare team, including any recommendations regarding coping with stress, anxiety, depressive symptoms, resilience, and quality of life related to their breast cancer diagnosis and treatment.

Other: Standard of Care (SOC)

Interventions

Intervention sessionsOTHER

7 week sessions

COPE Intervention
Standard of Care (SOC)OTHER

Given by Questionnaires

Control Group

Eligibility Criteria

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

You may not qualify if:

  • Diagnosed with multiple tumor types
  • Diagnosed with stage IV breast cancer
  • Unable to provide consent, such as cognitively impaired individuals
  • Has a preexisting psychiatric diagnosis (e.g., bipolar depression)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Eileen D Hacker, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen D Hacker, MD

CONTACT

713-563-4004ehacker@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 28, 2026

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2029

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations

US(1)