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Behavioral Intervention

Acceptance and Commitment Therapy for Breast Cancer

N/A

Waitlist Available

Led By Catherine E Mosher, Ph.D.

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks, 3 months, and 6 months post-intervention

Awards & highlights

Study Summary

This trial is testing whether a type of psychotherapy called Acceptance and Commitment Therapy (ACT) can help reduce fatigue, interference with activities, mood, and cognition in people with metastatic breast cancer (MBC). 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 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

Eligible Conditions

Metastatic Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks, 3 months, and 6 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks, 3 months, and 6 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 3 months, and 6 months post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Fatigue Interference subscale of Fatigue Symptom Inventory

Secondary outcome measures

Change in Functional Assessment of Cancer Therapy-General

Change in PROMIS Ability to Participate in Social Roles and Activities

Change in Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Acceptance and Commitment TherapyExperimental Treatment1 Intervention

Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.

Group II: Education/SupportActive Control1 Intervention

Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acceptance and Commitment Therapy

2010

Completed Phase 1

~1490

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER

1,585 Previous Clinical Trials

916,981 Total Patients Enrolled

39 Trials studying Breast Cancer

12,475 Patients Enrolled for Breast Cancer

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,732 Total Patients Enrolled

16 Trials studying Breast Cancer

3,570 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,239 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Media Library

Acceptance and Commitment Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03998618 — N/A

Breast Cancer Research Study Groups: Acceptance and Commitment Therapy, Education/Support

Breast Cancer Clinical Trial 2023: Acceptance and Commitment Therapy Highlights & Side Effects. Trial Name: NCT03998618 — N/A

Acceptance and Commitment Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03998618 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to join this experimental research?

"Affirmative. Data available on clinicaltrials.gov reveals that this scientific experiment, initially posted in June of 2019, is actively seeking participants. Approximately 250 individuals must be recruited from a single research facility."

Answered by AI

What is the current enrollment size of this experiment?

"Affirmative, the contents on clinicaltrials.gov demonstrate that this medical experiment is actively recruiting volunteers. It was initially announced on June 20th 2019 and has been edited as of December 29 2021. The study requires 250 participants from one location."

Answered by AI

Has the FDA confirmed the efficacy of Acceptance and Commitment Therapy?

"This treatment is backed by preliminary safety evidence, resulting in an estimated score of 2. Unfortunately, there are no available studies which have looked at the efficacy of Acceptance and Commitment Therapy at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telephone Support for Metastatic Breast Cancer Patients

Catherine Mosher 2019. "Telephone Support for Metastatic Breast Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03998618.