Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Northwestern University
Updated on 19 February 2024
cancer
breast cancer
acceptance and commitment therapy
stage iv breast cancer
female 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.

Details
Condition Metastatic Breast Cancer
Age 18-100 years
Treatment Acceptance and Commitment Therapy (ACT), Cognitive Behavioral Stress Management (CBSM)
Clinical Study IdentifierNCT04374825
SponsorNorthwestern University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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