Telephone Support for Metastatic Breast Cancer Patients

Not Applicable

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Behavioral: Acceptance and Commitment Therapy; Behavioral: Education/Support

• Registration Number: NCT03998618
• Lead Sponsor: Indiana University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-10
• Study Start: 2019-06-20
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-26
• Primary Completion: 2023-09-13
• Study Completion: 2023-09-13
• Results First Submitted: 2024-09-12
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Results First Posted: 2024-10-10
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acceptance and Commitment Therapy	Acceptance and Commitment Therapy	Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Education/Support	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.

Primary Outcome Measures

Name	Time	Method
Fatigue Interference Subscale of Fatigue Symptom Inventory	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. 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.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment	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). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome.
PROMIS Ability to Participate in Social Roles and Activities	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. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome.
Functional Assessment of Cancer Therapy-General	2 weeks, 3 months, and 6 months post-intervention	This 27-item measure evaluates physical, social/family, emotional, and functional quality of life. For each of the 4 subscale scores (i.e., Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being), the items are summed, multiplied by the number of items, and divided by the number of items answered, with higher scores indicating better quality of life. Items are rated on 0 to 4 scales. The physical well-being subscale is the sum of 7 items (all items reverse-coded) with a range of 0 to 28. The social/family well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. The emotional well-being subscale is the sum of 6 items (5 items reverse-coded) with a range of 0 to 24. The functional well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. This is a secondary outcome measure.

Trial Locations

Locations (3)

Robert H. Lurie Comprehensive Cancer Center of Northwestern University; 🇺🇸 Chicago, Illinois, United States

Indiana University Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Community Health Network; 🇺🇸 Indianapolis, Indiana, United States