Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

Northwestern University

Status: Completed

Conditions: Metastatic Breast Cancer

Treatments: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Cognitive Behavioral Stress Management (CBSM)

Study type: Interventional

Funder types: Other

Identifiers

NCT04374825

STU00209333 (Other Identifier)

SP0048722

IRG-18-163-24 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

Acceptance and Commitment Therapy (ACT)

Experimental group

Description:

Weekly video conference groups led by a trained facilitator introducing key concepts of ACT

Treatment:

Behavioral: Acceptance and Commitment Therapy (ACT)

Cognitive Behavioral Stress Management (CBSM)

Active Comparator group

Description:

Weekly video conference groups led by a trained facilitator introducing key concepts of CBSM

Treatment:

Behavioral: Cognitive Behavioral Stress Management (CBSM)

Usual care

No Intervention group

Description:

Patients' usual health care as received over the duration of the pilot trial