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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 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

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER
1,601 Previous Clinical Trials
915,414 Total Patients Enrolled
39 Trials studying Breast Cancer
12,475 Patients Enrolled for Breast Cancer
Indiana UniversityLead Sponsor
993 Previous Clinical Trials
1,095,039 Total Patients Enrolled
16 Trials studying Breast Cancer
3,570 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,114 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 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
~42 spots leftby Jun 2025
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