Creating Opportunities For Personal Empowerment (COPE) In Women With Breast Cancer During First-Line Therapy: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; First Line Therapy; Randomized Controlled Trial (RCT); COPE
• Intervention / Treatment: Other: Intervention sessions; Other: Standard of Care (SOC)

Detailed Description

Primary Objectives The primary objective of this study is to assess the feasibility and acceptability of the COPE intervention, a nurse-led cognitive-behavioral skills-building intervention, in women undergoing their first line of treatment for breast cancer.

• The primary endpoint of feasibility will be evaluated by the percentage of participants in the intervention arm who completes at least five of the seven intervention sessions. If at least 70% of the intervention group participants complete five or more intervention sessions, the COPE intervention will be deemed feasible in women undergoing their first line of treatment for breast cancer.
• The primary endpoint of acceptability will be evaluated by an investigator-developed instrument, the Acceptability of COPE in Breast Cancer Intervention Survey, The COPE intervention will be evaluated as acceptable if ≥50% of participants report that the intervention increased their ability to cope with their breast cancer diagnosis in their response to Question 1, "The COPE sessions affected my ability to cope with my breast cancer diagnosis in the following way: A) Increased my ability to cope with my breast cancer diagnosis: B) Decreased my ability to cope with my breast cancer diagnosis; or C) No change in my ability to cope with my breast cancer diagnosis."

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eileen D Hacker, MD; Phone Number: 713-563-4004; Email: ehacker@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
      • Contact: Eileen D Hacker, MD; Phone Number: 713-563-4004; Email: ehacker@mdanderson.org
      • Principal Investigator: Eileen D Hacker, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Eligibility Criteria

• Female
• Age 18 years and older
• Diagnosed with stage I-III breast cancer
• Receiving first line treatment for breast cancer
• Receiving treatment at MD Anderson
• Able to read, speak, and consent in English
• Able to understand and be willing to sign a written informed consent document
• Able to complete the study questionnaires and intervention sessions

Exclusion Criteria

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPE Intervention; 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; 7 week sessions
Other: Control Group; 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); Given by Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient-Reported Outcomes Measurement Questionnaire	Through study completion; an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Eileen D Hacker, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2026-0163; NCI-2026-03932 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No