Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

NCT ID: NCT04374825

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-24
• Study Completion Date: 2021-03-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Acceptance and Commitment Therapy (ACT)

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

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy (ACT)

Intervention Type: 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).

Cognitive Behavioral Stress Management (CBSM)

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

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Stress Management (CBSM)

Intervention Type: 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).

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Patricia Moreno

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00209333

Identifier Type: OTHER

Identifier Source: secondary_id

IRG-18-163-24

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SP0048722

Identifier Type: -

Identifier Source: org_study_id