Telephone Support for Metastatic Breast Cancer Patients
2 other identifiers
interventional
250
1 country
3
Brief Summary
This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in metastatic breast cancer (MBC) cancer patients. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, work), and engaging in activities consistent with these values. A total of 250 patients will be randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Patients in both conditions will participate in six weekly 50-minute telephone sessions. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. A demonstration of ACT's efficacy will lead to dissemination of the intervention and ultimately fulfill an unmet need in the comprehensive care of MBC patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2019
CompletedStudy Start
First participant enrolled
June 20, 2019
CompletedFirst Posted
Study publicly available on registry
June 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2023
CompletedResults Posted
Study results publicly available
October 10, 2024
CompletedOctober 10, 2024
October 1, 2024
4.2 years
June 10, 2019
September 12, 2024
October 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue Interference Subscale of Fatigue Symptom Inventory
Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome.
2 weeks, 3 months, and 6 months post-intervention
Secondary Outcomes (3)
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment
2 weeks, 3 months, and 6 months post-intervention
PROMIS Ability to Participate in Social Roles and Activities
2 weeks, 3 months, and 6 months post-intervention
Functional Assessment of Cancer Therapy-General
2 weeks, 3 months, and 6 months post-intervention
Study Arms (2)
Acceptance and Commitment Therapy
EXPERIMENTALPatients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Education/Support
ACTIVE COMPARATORPatients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
Interventions
Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework.
Eligibility Criteria
You may qualify if:
- Patient is at least 3 weeks post-diagnosis of stage IV breast cancer and is receiving care at the Indiana University (IU) Simon Cancer Center, Eskenazi Health, IU Health North, IU Health Bloomington, IU Health Ball Memorial, IU Health Portland, IU Health Morgan, IU Health New Castle, IU Health Central-Fishers, another IU Health hospital or clinic, Community Health Network, or the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.
- Patient is at least 18 years of age.
- Patient has adequate English fluency for completion of data collection.
- Patient has moderate to severe fatigue interference with functioning
You may not qualify if:
- Patient shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
- Patient reports being able to do little activity on a functional status measure.
- Patient is receiving hospice care at screening.
- Patient does not have working phone service.
- Patient has hearing impairment that precludes participation.
- Male sex
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- National Cancer Institute (NCI)collaborator
- Eskenazi Healthcollaborator
- Community Health Networkcollaborator
- Indiana University Healthcollaborator
- Northwestern Universitycollaborator
Study Sites (3)
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611, United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Community Health Network
Indianapolis, Indiana, 46256, United States
Related Publications (1)
Mosher CE, Lee S, Addington EL, Park S, Lewson AB, Snyder S, Hirsh AT, Bricker JB, Miller KD, Ballinger TJ, Schneider BP, Storniolo AM, Newton EV, Champion VL, Johns SA. Randomized Controlled Trial of Acceptance and Commitment Therapy for Fatigue Interference With Functioning in Metastatic Breast Cancer. J Clin Oncol. 2025 Feb 20;43(6):662-671. doi: 10.1200/JCO.24.00965. Epub 2024 Oct 25.
PMID: 39454125DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Catherine Mosher
- Organization
- Indiana University
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine E Mosher, Ph.D.
Indiana University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 10, 2019
First Posted
June 26, 2019
Study Start
June 20, 2019
Primary Completion
September 13, 2023
Study Completion
September 13, 2023
Last Updated
October 10, 2024
Results First Posted
October 10, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. Data will be available for at least 6 years.
- Access Criteria
- The data set and supporting information will be made available to qualified investigators to allow replication of analyses or secondary data analyses. The PI will review requests for data access. The investigators will be required to sign a data use agreement and obtain IRB approval before receiving the data set. The mechanism for data sharing will be reviewed by the IRB.
Results of this trial will be presented at professional meetings and published in peer-reviewed journals. The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. The data set will contain necessary identifiers, excluding those prohibited by HIPAA. The investigators will be required to sign a data use agreement and obtain Institutional Review Board (IRB) approval before receiving the data set.