Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

NCT04374825 | Completed DMC

• 3 other identifiers: SP0048722STU00209333IRG-18-163-24
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic female breast cancer; Acceptance and Commitment Therapy; Stress management; eHealth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in meaning and purpose in life and positive affect

  Approx. 3 months

• Change in social support

  Approx. 3 months

Other Outcomes (3)

• Change in coping self-efficacy

  Approx. 3 months

• Change in acceptance

  Approx. 3 months

• Change in open and engaged state

  Approx. 3 months

Study Arms (3)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

Weekly video conference groups led by a trained facilitator introducing key concepts of ACT

Behavioral: Acceptance and Commitment Therapy (ACT)

Cognitive Behavioral Stress Management (CBSM)

ACTIVE COMPARATOR

Weekly video conference groups led by a trained facilitator introducing key concepts of CBSM

Behavioral: Cognitive Behavioral Stress Management (CBSM)

Usual care

NO INTERVENTION

Patients' usual health care as received over the duration of the pilot trial

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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).

Acceptance and Commitment Therapy (ACT)

Cognitive Behavioral Stress Management (CBSM) BEHAVIORAL

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).

Cognitive Behavioral Stress Management (CBSM)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 5, 2020
• Study Start: April 24, 2019
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

US (1)