Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Optimizing Quality of Life in Women Living With Metastatic Breast Cancer: Feasibility and Preliminary Efficacy of a Tailored, eHealth Supportive Oncology Intervention

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy (ACT)
* Behavioral: Cognitive Behavioral Stress Management (CBSM)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients participating in the online pilot will be randomized to 1 of 3 study arms: 1) a usual care control, 2) CBSM, and 3) ACT. Women taking part in the intervention trial (i.e. women living with Stage IV [M1] breast cancer) will complete self-report psychosocial measures online at four assessments. Change across time will be assessed from baseline to mid-intervention (Week 4 of 8), immediately post-intervention (Week 8), and a one month follow-up.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and Commitment Therapy (ACT)<br>Weekly video conference groups led by a trained facilitator introducing key concepts of ACT | Behavioral: Acceptance and Commitment Therapy (ACT)<br>* This intervention consists of 8, 90-minute online group sessions delivered via video conference. Content will be developed by tailoring an ACT intervention to the specific needs of women with MBC, by using qualitative data gathered in patient focus groups. The intervention will incorporate key concepts of ACT (i.e., creating meaning and purpose in life via coping skills, activities in line with patients' values, and mindfulness meditation).<br>|
| Active Comparator: Cognitive Behavioral Stress Management (CBSM)<br>Weekly video conference groups led by a trained facilitator introducing key concepts of CBSM | Behavioral: Cognitive Behavioral Stress Management (CBSM)<br>* This intervention consists of 8, 90-minute online group sessions delivered via videoconference. Content is drawn from a standard published CBSM intervention previously tested in other studies. The intervention incorporates key concepts of CBSM (i.e., managing stress via deep breathing and relaxation, identifying distorted thoughts,cognitive restructuring, and effective interpersonal communication).<br>|
| No Intervention: Usual care<br>Patients' usual health care as received over the duration of the pilot trial | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life (HRQoL) | 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. | Approx. 3 months | 
| Change in wellbeing and disease symptom bother | 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. | Approx. 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in meaning and purpose in life and positive affect | 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. | Approx. 3 months | 
| Change in social support | 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. | Approx. 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic female breast cancer, Acceptance and Commitment Therapy, Stress management, eHealth