Clinical trial NCT04374825: Optimizing Quality of Life in Women Living With Metastatic Breast Cancer
Official title: Optimizing Quality of Life in Women Living With Metastatic Breast Cancer: Feasibility and Preliminary Efficacy of a Tailored, eHealth Supportive Oncology Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: Metastatic female breast cancer
Acceptance and Commitment Therapy
Stress management
eHealth
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2020-05-05
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in health-related quality of life (HRQoL)
timeFrame: Approx. 3 months
measure: Change in wellbeing and disease symptom bother
timeFrame: Approx. 3 months
Secondary outcomes:
measure: Change in meaning and purpose in life and positive affect
timeFrame: Approx. 3 months
measure: Change in social support
timeFrame: Approx. 3 months
Other outcomes:
measure: Change in coping self-efficacy
timeFrame: Approx. 3 months
measure: Change in acceptance
timeFrame: Approx. 3 months
measure: Change in open and engaged state
timeFrame: Approx. 3 months
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
References: