Creating Opportunities For Personal Empowerment (COPE) In Women With Breast Cancer During First-Line Therapy: A Pilot Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care (SOC), Intervention sessions.
- Who it may be relevant to
- Registry conditions: COPE, Breast Cancer, First Line Therapy, Randomized Controlled Trial (RCT). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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."
Interventions
- Other Standard of Care (SOC)
Given by Questionnaires - Other Intervention sessions
7 week sessions
Primary outcome measures
- Patient-Reported Outcomes Measurement Questionnaire [Time frame: Through study completion; an average of 1 year]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT07610499 · 2026-0163 · NCI-2026-03932