Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

Not Applicable

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Cognitive Behavioral Stress Management (CBSM)

• Registration Number: NCT04374825
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-24
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-05
• Primary Completion: 2021-03-08
• Study Completion: 2021-03-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acceptance and Commitment Therapy (ACT)	Acceptance and Commitment Therapy (ACT)	Weekly video conference groups led by a trained facilitator introducing key concepts of ACT
Cognitive Behavioral Stress Management (CBSM)	Cognitive Behavioral Stress Management (CBSM)	Weekly video conference groups led by a trained facilitator introducing key concepts of CBSM

Primary Outcome Measures

Name	Time	Method
Change in wellbeing and disease symptom bother	Approx. 3 months	Using the previously validated Functional Assessment of Cancer-Therapy-Breast (FACT-B), change in wellbeing and symptom bother will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.
Change in health-related quality of life (HRQoL)	Approx. 3 months	Using the previously validated NIH PROMIS profile, change in HRQoL will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.

Secondary Outcome Measures

Name	Time	Method
Change in meaning and purpose in life and positive affect	Approx. 3 months	Using the previously validated PROMIS Short Forms for Meaning and Purpose and Positive Affect, change in meaning and purpose in life and positive affect will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.
Change in social support	Approx. 3 months	Using the previously validated PROMIS Short Forms for Social Isolation, Emotional Support, and Informational Support, change in social support will be assessed from baseline to 1. mid-intervention (week 4), 2. immediately post-intervention (week 8), and a 3. one month follow-up.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States