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Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT04374825
Recruitment Status : Active, not recruiting
First Posted : May 5, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Patricia Moreno, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Behavioral: Acceptance and Commitment Therapy (ACT) Behavioral: Cognitive Behavioral Stress Management (CBSM) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Optimizing Quality of Life in Women Living With Metastatic Breast Cancer: Feasibility and Preliminary Efficacy of a Tailored, eHealth Supportive Oncology Intervention
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : April 26, 2021
Estimated Study Completion Date : April 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Acceptance and Commitment Therapy (ACT)
Weekly video conference groups led by a trained facilitator introducing key concepts of ACT
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).

Active Comparator: Cognitive Behavioral Stress Management (CBSM)
Weekly video conference groups led by a trained facilitator introducing key concepts of CBSM
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).

No Intervention: Usual care
Patients' usual health care as received over the duration of the pilot trial



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374825


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
American Cancer Society, Inc.
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Responsible Party: Patricia Moreno, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT04374825    
Other Study ID Numbers: SP0048722
STU00209333 ( Other Identifier: Northwestern University Institutional Review Board )
IRG-18-163-24 ( Other Grant/Funding Number: American Cancer Society )
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patricia Moreno, Northwestern University:
Metastatic female breast cancer
Acceptance and Commitment Therapy
Stress management
eHealth
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases