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Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

Primary Purpose

Metastatic Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acceptance and Commitment Therapy (ACT)

Cognitive Behavioral Stress Management (CBSM)

About this trial

This is an interventional supportive care trial for Metastatic Breast Cancer focused on measuring Metastatic female breast cancer, Acceptance and Commitment Therapy, Stress management, eHealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Acceptance and Commitment Therapy (ACT)

Cognitive Behavioral Stress Management (CBSM)

Usual care

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04374825

First Posted

April 29, 2020

Last Updated

August 31, 2021

Sponsor

Northwestern University

Collaborators

American Cancer Society, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04374825

Brief Title

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

April 24, 2019 (Actual)

Primary Completion Date

March 8, 2021 (Actual)

Study Completion Date

March 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acceptance and Commitment Therapy (ACT)

Arm Type

Experimental

Arm Description

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

Arm Title

Cognitive Behavioral Stress Management (CBSM)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Acceptance and Commitment Therapy (ACT)

Intervention Description

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

Intervention Name(s)

Cognitive Behavioral Stress Management (CBSM)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change in health-related quality of life (HRQoL)

Description

Time Frame

Approx. 3 months

Title

Change in wellbeing and disease symptom bother

Description

Time Frame

Approx. 3 months

Secondary Outcome Measure Information:

Title

Change in meaning and purpose in life and positive affect

Description

Time Frame

Approx. 3 months

Title

Change in social support

Description

Time Frame

Approx. 3 months

Other Pre-specified Outcome Measures:

Title

Change in coping self-efficacy

Description

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.

Time Frame

Approx. 3 months

Title

Change in acceptance

Description

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.

Time Frame

Approx. 3 months

Title

Change in open and engaged state

Description

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.

Time Frame

Approx. 3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

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Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

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