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Metastatic Breast CancerNCT03998618

Telephone Support for Metastatic Breast Cancer Patients

A study testing Acceptance and Commitment Therapy and Education/Support in people with Metastatic Breast Cancer, run by Indiana University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Acceptance and Commitment Therapy and Education/Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
3 sitesUnited States
Study dates
20 Jun 2019to 13 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • Indiana University Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

  • Community Health Network

    Indianapolis, Indiana, 46256

Other trials in United States

About this study

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.

Read the 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.

Being tested
Acceptance and Commitment Therapy, Education/Support
Keywords
psychotherapy, fatigue, quality of life
Medical subject headings
Breast Neoplasms, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment TherapyBehavioural

    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.

  • Education/SupportBehavioural

    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.

Study groups in NCT03998618
Study groupRoleWhat they receive
Acceptance and Commitment TherapyExperimentalPatients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Receives: Behavioral: Acceptance and Commitment Therapy
Education/SupportActive comparatorPatients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
Receives: Behavioral: Education/Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatigue Interference Subscale of Fatigue Symptom Inventory

    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.

    Measured: 2 weeks, 3 months, and 6 months post-intervention

Secondary outcomes (3)

  1. Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment

    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.

    Measured: 2 weeks, 3 months, and 6 months post-intervention

  2. PROMIS Ability to Participate in Social Roles and Activities

    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.

    Measured: 2 weeks, 3 months, and 6 months post-intervention

  3. Functional Assessment of Cancer Therapy-General

    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.

    Measured: 2 weeks, 3 months, and 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2019
  2. Study start20 Jun 2019
  3. Primary completion13 Sep 2023
  4. Study completion13 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03998618
Sponsor's protocol ID
1812850942
Other IDs
R01CA230542
Status last verified
Oct 2024
First submitted
10 Jun 2019
Last updated
10 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Mosher CE, Lee S, Addington EL, Park S, Lewson AB, Snyder S, Hirsh AT, Bricker JB, Miller KD, Ballinger TJ, Schneider BP, Storniolo AM, Newton EV, Champion VL, Johns SA. Randomized Controlled Trial of Acceptance and Commitment Therapy for Fatigue Interference With Functioning in Metastatic Breast Cancer. J Clin Oncol. 2025 Feb 20;43(6):662-671. doi: 10.1200/JCO.24.00965. Epub 2024 Oct 25.

    PubMed 39454125

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy and Education/Support in people with Metastatic Breast Cancer, run by Indiana University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue Interference Subscale of Fatigue Symptom Inventory (time frame: 2 weeks, 3 months, and 6 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03998618, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.

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