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NCT03998618 · ClinicalTrials.gov registry record · NA

Telephone Support for Metastatic Breast Cancer Patients

A NA study, sponsored by Indiana University.

Completed
Registry status
NA
Development phase
250
Enrollment target

NCT03998618 is a NA study that has completed, run by Indiana University. The registered enrollment target is 250 participants.

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The verdict

NCT03998618, a NA study, has completed, sponsored by Indiana University.

COMPLETED
Registry status
NA
Development phase
250 participants
Enrollment target

Study 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.

Interventions

  • BEHAVIORAL Acceptance and Commitment Therapy
  • BEHAVIORAL Education/Support

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2019-06-20
Est. Completion 2023-09-13
Phase NA

Sponsor

Indiana University

890 total trials

What the Registry Record Tells You About NCT03998618

The ClinicalTrials.gov registry entry for NCT03998618 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Acceptance and Commitment Therapy is the first listed.

NCT03998618 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03998618 about?

NCT03998618 is a clinical study titled "Telephone Support for Metastatic Breast Cancer Patients". 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 ...

What is the current status of trial NCT03998618?

This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2019-06-20. Estimated completion is 2023-09-13.

What interventions are being tested in trial NCT03998618?

The interventions under investigation include: Acceptance and Commitment Therapy (BEHAVIORAL), Education/Support (BEHAVIORAL).

Who is sponsoring clinical trial NCT03998618?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.