- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03998618
Telephone Support for Metastatic Breast Cancer Patients
October 17, 2023 updated by: Catherine Mosher, Indiana University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This trial tests the effect of telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference in metastatic breast cancer (MBC) patients (Aim 1) as well as secondary outcomes (Aim 2).
This trial also examines increases in psychological flexibility as a hypothesized mediator of ACT's effect on fatigue interference (Aim 3).
Finally, two core aspects of psychological flexibility (i.e., mindfulness/acceptance and commitment/behavior change processes) are examined as exploratory mediators of ACT's effect on fatigue interference.
The study team will recruit MBC patients receiving care through Eskenazi Health or Indiana University (IU) Health.
Potentially eligible patients will be mailed an introductory letter signed by their oncologist and the PI along with a consent form.
The letter will have a number to call if they do not wish to be contacted further.
A research assistant (RA) will call all prospective participants who do not opt out approximately 1 to 2 weeks after the letter is mailed.
The RA will describe the study as outlined in the consent form and answer any questions.
Then the RA will administer an eligibility screening to those who consent to participate.
Eligible and consenting patients will complete a 35-minute baseline phone assessment.
Following baseline assessments, MBC patients (N = 250) will be randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by age (<65 yrs. vs. 65+ yrs.) and performance status (patient-reported Eastern Cooperative Oncology Group [ECOG] scores 0 or 1 vs. 2).
Patients in both study conditions will complete six weekly 50-minute telephone sessions with the first session occurring one week after baseline.
For ACT participants, adherence to home practice during the past week will be assessed and recorded during each session.
Blind interviewers will assess outcomes and potential mediators during 30-minute follow-up phone assessments at 2 weeks, 3 months, and 6 months post-intervention.
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julie Hughes, B.S.
- Phone Number: 3172784009
- Email: cancerq@iu.edu
Study Contact Backup
- Name: Ellen Krueger, B.S.
- Phone Number: 3172782989
- Email: cancerq@iu.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Simon Comprehensive Cancer Center
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Indianapolis, Indiana, United States, 46256
- Community Health Network
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acceptance and Commitment Therapy
Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
|
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.
|
Active Comparator: Education/Support
Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fatigue Interference subscale of Fatigue Symptom Inventory
Time Frame: 2 weeks, 3 months, and 6 months post-intervention
|
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.
Higher scores indicate greater fatigue interference.
|
2 weeks, 3 months, and 6 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment
Time Frame: 2 weeks, 3 months, and 6 months post-intervention
|
This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks).
Each item is rated on a scale from 1 (not at all) to 5 (very much) with higher scores indicating greater sleep-related impairment.
|
2 weeks, 3 months, and 6 months post-intervention
|
Change in PROMIS Ability to Participate in Social Roles and Activities
Time Frame: 2 weeks, 3 months, and 6 months post-intervention
|
This 6-item measure assesses participants' ability to participate in social roles and activities.
The items measure difficulty engaging in social and recreational activities as well as usual work (including housework).
Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded such that a higher score indicates greater ability to participate in activities.
|
2 weeks, 3 months, and 6 months post-intervention
|
Change in Functional Assessment of Cancer Therapy-General
Time Frame: 2 weeks, 3 months, and 6 months post-intervention
|
This 27-item quality of life measure consists of four subscales: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being.
Each item is rated on a scale from 0 = not at all to 4 = very much.
An overall score is computed to represent general quality of life, with higher scores indicating better quality of life.
|
2 weeks, 3 months, and 6 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Catherine E Mosher, Ph.D., Indiana University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2019
Primary Completion (Actual)
September 13, 2023
Study Completion (Actual)
September 13, 2023
Study Registration Dates
First Submitted
June 10, 2019
First Submitted That Met QC Criteria
June 24, 2019
First Posted (Actual)
June 26, 2019
Study Record Updates
Last Update Posted (Actual)
October 19, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1812850942
- R01CA230542 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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