Telephone Support for Metastatic Breast Cancer Patients

• ClinicalTrials.gov Identifier: NCT03998618
• Recruitment Status: Active, not recruiting
• First Posted: June 26, 2019
• Last Update Posted: March 13, 2023
• Sponsor: Indiana University
• Collaborators: National Cancer Institute (NCI); Eskenazi Health; Community Health Network; Indiana University Health; Northwestern University
• Information provided by (Responsible Party): Catherine Mosher, Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metastatic Breast Cancer	Behavioral: Acceptance and Commitment Therapy; Behavioral: Education/Support	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 250 participants
• Allocation: Randomized
• 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

Arms and Interventions

Arm	Intervention/treatment
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.	Behavioral: Education/Support; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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. 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.
3. 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Indiana University

National Cancer Institute (NCI)

Eskenazi Health

Community Health Network

Indiana University Health

Northwestern University

Investigators

• Principal Investigator: Catherine E Mosher, Ph.D.; Indiana University

More Information

• Responsible Party: Catherine Mosher, Associate Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT03998618
• Other Study ID Numbers: 1812850942; R01CA230542 ( U.S. NIH Grant/Contract )
• First Posted: June 26, 2019
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catherine Mosher, Indiana University:

psychotherapy; fatigue; quality of life

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases