- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04374825
Optimizing Quality of Life in Women Living With Metastatic Breast Cancer
August 31, 2021 updated by: Patricia Moreno, Northwestern University
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
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
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
|
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
|
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)
Time Frame: 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.
|
Approx. 3 months
|
Change in wellbeing and disease symptom bother
Time Frame: 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.
|
Approx. 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in meaning and purpose in life and positive affect
Time Frame: 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.
|
Approx. 3 months
|
Change in social support
Time Frame: 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.
|
Approx. 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in coping self-efficacy
Time Frame: Approx. 3 months
|
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
Time Frame: Approx. 3 months
|
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
Time Frame: Approx. 3 months
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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