Telephone Support for Metastatic Breast Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03998618|
Recruitment Status : Active, not recruiting
First Posted : June 26, 2019
Last Update Posted : March 13, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Behavioral: Acceptance and Commitment Therapy Behavioral: Education/Support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Metastatic breast cancer patients (N = 250) will be randomly assigned in equal numbers to Acceptance and Commitment Therapy (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).|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Telephone Support for Metastatic Breast Cancer Patients|
|Actual Study Start Date :||June 20, 2019|
|Estimated Primary Completion Date :||September 19, 2023|
|Estimated Study Completion Date :||September 19, 2023|
Experimental: Acceptance and Commitment Therapy
Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Behavioral: Acceptance and Commitment Therapy
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.
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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): NCT03998618
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center of Northwestern University|
|Chicago, Illinois, United States, 60611|
|United States, Indiana|
|Indiana University Simon Comprehensive Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Community Health Network|
|Indianapolis, Indiana, United States, 46256|
|Principal Investigator:||Catherine E Mosher, Ph.D.||Indiana University|
|Responsible Party:||Catherine Mosher, Associate Professor, Indiana University|
|Other Study ID Numbers:||
R01CA230542 ( U.S. NIH Grant/Contract )
|First Posted:||June 26, 2019 Key Record Dates|
|Last Update Posted:||March 13, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|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.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
quality of life
Neoplasms by Site