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
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.
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 underg…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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.,…
Interventions
- OtherStandard of Care (SOC)
Given by Questionnaires
- OtherIntervention sessions
7 week sessions
Location
- MD Anderson Cancer CenterHouston, Texas