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

ConditionsCOPE Breast Cancer First Line Therapy Randomized Controlled Trial (RCT)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female

Age 18 years and older

Diagnosed with stage I-III breast cancer

Receiving first line treatment for breast cancer

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

Standard of Care (SOC)
Other intervention
Given by Questionnaires
Intervention sessions
Other intervention
7 week sessions

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: COPE InterventionExperimental treatment 1 intervention

Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

Patient-Reported Outcomes Measurement Questionnaire

Time frame

Through study completion; an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: