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

Sponsored by M.D. Anderson Cancer Center

About this study

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.

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 Inte…

Where this study is enrolling

Who can participate

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)

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Trial data sourced from ClinicalTrials.gov.