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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07610499
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer
  • COPE
  • First Line Therapy
  • Randomized Controlled Trial (RCT)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care (SOC) — OTHER
    Given by Questionnaires
  • Intervention sessions — OTHER
    7 week sessions

Study Details

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.

Key Dates

Start date
Oct 30, 2026
Status verified
May 2026
Primary completion
May 1, 2027
Completion
May 1, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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: 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.

Primary Outcome Measure

Patient-Reported Outcomes Measurement Questionnaire [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Eileen D Hacker, MD
[email protected]
713-563-4004
Eileen D Hacker, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
MD Anderson Cancer Center· Houston, TX

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