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

M.D. Anderson Cancer Center

Status: Begins enrollment in 3 months

Conditions: Randomized Controlled Trial (RCT); Breast Cancer; First Line Therapy; COPE

Treatments: Other: Intervention sessions; Other: Standard of Care (SOC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07610499

NCI-2026-03932 (Other Identifier)

2026-0163

Details and patient eligibility

About

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.

Full 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."

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

COPE Intervention

Experimental group

Description:

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.

Treatment:

Other: Intervention sessions

Control Group

Other group

Description:

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.

Treatment:

Other: Standard of Care (SOC)