Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Cognitive Behavioral Stress Management (CBSM)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acceptance and Commitment Therapy (ACT); Weekly video conference groups led by a trained facilitator introducing key concepts of ACT	Behavioral: Acceptance and Commitment Therapy (ACT); 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).
ACTIVE_COMPARATOR: Cognitive Behavioral Stress Management (CBSM); Weekly video conference groups led by a trained facilitator introducing key concepts of CBSM	Behavioral: Cognitive Behavioral Stress Management (CBSM); 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).
NO_INTERVENTION: Usual care; Patients' usual health care as received over the duration of the pilot trial

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in coping self-efficacy	Using the previously validated Measure of Current Status (MOCS) Self-Efficacy Scale, change in coping self-efficacy 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 acceptance	Using the previously validated Acceptance and Action Questionnaire-II, change in acceptance 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 open and engaged state	Using the previously validated Open and Engaged State Questionnaire, change in open and engaged state 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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: American Cancer Society, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 24, 2019
• Primary Completion (ACTUAL): March 8, 2021
• Study Completion (ACTUAL): March 8, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (ACTUAL): May 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; eHealth; Stress management; Metastatic female breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SP0048722; STU00209333 (OTHER: Northwestern University Institutional Review Board); IRG-18-163-24 (Other Grant/Funding Number: American Cancer Society)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No