Clinical Trial: NCT03998618 - My Cancer Genome

NCT03998618

Description:

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.

Related Conditions:

Breast Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03998618

Trial Eligibility

Document

Title

Brief Title: Telephone Support for Metastatic Breast Cancer Patients
Official Title: Telephone Support for Metastatic Breast Cancer Patients

Clinical Trial IDs

ORG STUDY ID: 1812850942
SECONDARY ID: R01CA230542
NCT ID: NCT03998618

Conditions

Metastatic Breast Cancer

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
Acceptance and Commitment Therapy	Experimental	Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Education/Support	Active Comparator	Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.

Eligibility 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, or Community Health Network.

          -  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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Fatigue Interference subscale of Fatigue Symptom Inventory
Time Frame:	2 weeks post-intervention
Safety Issue:
Description:	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

Measure:	PROMIS Sleep-related Impairment
Time Frame:	2 weeks post-intervention
Safety Issue:
Description:	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.

Measure:	PROMIS Ability to Participate in Social Roles and Activities
Time Frame:	2 weeks post-intervention
Safety Issue:
Description:	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.

Measure:	Functional Assessment of Cancer Therapy-General
Time Frame:	2 weeks post-intervention
Safety Issue:
Description:	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.

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Indiana University

Trial Keywords

psychotherapy
fatigue
quality of life

Last Updated

January 8, 2021

Clinical Trials /

Telephone Support for Metastatic Breast Cancer Patients