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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03998618|
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : January 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Behavioral: Acceptance and Commitment Therapy Behavioral: Education/Support||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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 :||October 31, 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 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.
- Fatigue Interference subscale of Fatigue Symptom Inventory [ Time Frame: 2 weeks 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.
- PROMIS Sleep-related Impairment [ Time Frame: 2 weeks 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.
- PROMIS Ability to Participate in Social Roles and Activities [ Time Frame: 2 weeks 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.
- Functional Assessment of Cancer Therapy-General [ Time Frame: 2 weeks 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.
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
|Contact: Isabella Stuart, B.S.||firstname.lastname@example.org|
|Contact: Ellen Krueger, B.S.||email@example.com|
|United States, Indiana|
|Indiana University Simon Cancer Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Isabella Stuart, B.S. 317-278-4009|
|Principal Investigator:||Catherine E Mosher, Ph.D.||Indiana University|