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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a program called Creating Opportunities for Personal Empowerment (COPE) for women receiving their first treatment for breast cancer. It compares COPE with usual care to see if the program is practical, acceptable to women, and helpful.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Have stage I, II, or III breast cancer.
  • Are receiving their first treatment for breast cancer.
  • Are receiving care at MD Anderson.
  • Can read, speak, and give consent in English.
  • Can understand and are willing to sign a form agreeing to join the study.
  • Can complete the study surveys and program sessions.

Who can't join

  • Have more than one type of tumor.
  • Have stage IV breast cancer, which has spread to distant parts of the body.
  • Cannot give consent, such as because of problems with thinking or understanding.
  • Have a previously diagnosed mental health condition, such as bipolar depression.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

TX