Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374825
• Other study ID #: SP0048722
• Secondary ID: STU00209333IRG-1
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: March 8, 2021

Study information

• Verified date: August 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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