Breast Cancer Clinical Trial

Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

Summary

The purpose of this study is to develop and tailor an intervention program to improve the quality of life in women living with metastatic breast cancer. In the first phase of this study, we conducted patient focus groups to gather information about the unique challenges of living with MBC and what kinds of support women would like to receive in a tailored Acceptance and Commitment Therapy (ACT) intervention. In the second phase of the study, we will conduct a three-arm randomized controlled trial to the tailored ACT intervention with both a Cognitive Behavioral Stress Management (CBSM) intervention and usual care. The CBSM and ACT intervention groups will meet with a trained facilitator and 8-9 other patients, once per week via videoconference for 90 minute sessions over the course of 8 weeks.

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Eligibility Criteria

Inclusion Criteria:

Patients must be diagnosed with metastatic (stage IV [M1]) female breast cancer, via physician diagnosis and confirmed through staff review of electronic medical record (i.e. imaging, surgical pathology reports, etc.).
Patients must be comfortable speaking English for participation in group sessions.
Patients must be age ≥ 18 years.
Patients taking part in the 8 week online pilot trial must have a physician-anticipated life expectancy of > 6 months.
Patients must have the ability to understand, and the willingness to sign, a written informed consent prior to registration on study.

Exclusion Criteria:

Patients who have severe or impairing psychiatric illness/social situations that would limit compliance with study requirements are not eligible to enroll.
Patients with early stage/non metastatic breast cancer (Stages I-III) are not eligible to enroll.

Study is for people with:

Breast Cancer

Estimated Enrollment:

31

Study ID:

NCT04374825

Recruitment Status:

Completed

Sponsor:

Northwestern University

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There is 1 Location for this study

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Northwestern University Feinberg School of Medicine
Chicago Illinois, 60611, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

31

Study ID:

NCT04374825

Recruitment Status:

Completed

Sponsor:


Northwestern University

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