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Psychological Therapies for Fear of Breast Cancer Recurrence

N/A

Waitlist Available

Led By Shelley A Johns, PsyD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Patient has been diagnosed with stage I-IIIA breast cancer without evidence of distant disease at time of study entry

Patient is ≥18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up given at baseline (t1), 2 months post-baseline (t2), 6 months post-baseline (t3), and 12 months post-baseline (t4)

Awards & highlights

Study Summary

This trial will compare two therapies for fear of cancer recurrence in breast cancer survivors to find out which is more effective. It will also examine the cost-effectiveness of the therapies and how they work.

Who is the study for?

This trial is for breast cancer survivors who've finished their main treatments within the last 5 years, are over 18, and suffer from significant fear of cancer recurrence. They must speak English and be willing to join videoconference group sessions. Those with a history of other cancers (except certain skin cancers), severe mental health issues, or communication disabilities cannot participate.Check my eligibility

What is being tested?

The study compares Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) against enhanced usual care in managing fear of cancer recurrence among breast cancer survivors. Participants will attend therapy via videoconference to see which method is more effective and cost-efficient.See study design

What are the potential side effects?

Since this trial involves psychological therapies rather than medications, traditional side effects like those seen with drugs are not expected. However, participants may experience emotional discomfort or distress as they confront fears related to cancer recurrence during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with early-stage breast cancer and it hasn't spread far.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ given at baseline (t1), 2 months post-baseline (t2), 6 months post-baseline (t3), and 12 months post-baseline (t4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~given at baseline (t1), 2 months post-baseline (t2), 6 months post-baseline (t3), and 12 months post-baseline (t4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and given at baseline (t1), 2 months post-baseline (t2), 6 months post-baseline (t3), and 12 months post-baseline (t4) 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 Fear of Cancer Recurrence from Baseline

Secondary outcome measures

Change in Anxiety Symptoms from Baseline

Change in Anxiety from Baseline

Change in Concerns about Recurrence (CARS) from Baseline

+9 more

Other outcome measures

Change in Commitment and Behavior Change

Change in Health-Related Quality of Life

Change in Mindfulness

+2 more

Trial Design

3Treatment groups

Active Control

Group I: Acceptance Commitment Therapy (ACT)Active Control1 Intervention

The ACT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.

Group II: Cognitive Behavioral Therapy (CBT)Active Control1 Intervention

The CBT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.

Group III: Enhanced Usual Care (EUC)Active Control1 Intervention

The EUC group will meet for a single 90-minute coaching session via Zoom Health.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,277 Total Patients Enrolled

18 Trials studying Anxiety

12,272 Patients Enrolled for Anxiety

Indiana University HealthOTHER

30 Previous Clinical Trials

15,643 Total Patients Enrolled

7 Trials studying Anxiety

1,986 Patients Enrolled for Anxiety

Eskenazi HealthOTHER

11 Previous Clinical Trials

2,444 Total Patients Enrolled

1 Trials studying Anxiety

778 Patients Enrolled for Anxiety

Media Library

Acceptance Commitment Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05364450 — N/A

Anxiety Research Study Groups: Acceptance Commitment Therapy (ACT), Cognitive Behavioral Therapy (CBT), Enhanced Usual Care (EUC)

Anxiety Clinical Trial 2023: Acceptance Commitment Therapy Highlights & Side Effects. Trial Name: NCT05364450 — N/A

Acceptance Commitment Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364450 — 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 available slots in this clinical trial?

"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial is actively enrolling patients, and was first posted on July 17th 2021. The current aim of the study is to recruit 375 participants from a single location."

Answered by AI

How many participants are being allowed to enter this medical experiment?

"Confirmed. The clinicaltrials.gov database indicates that this research project, first posted on July 17th 2021, is actively seeking candidates. 375 individuals should be enrolled from a single medical facility."

Answered by AI

Is this research open to adults aged 18 or older?

"This clinical trial is only open to those between the ages of 18 and 99. For minors, there are 609 studies available and for seniors over 65 there are 7536 research opportunities."

Answered by AI

Is this study open to volunteers right now?

"This research study necessitates 375 breast cancer patients aged 18 to 99. To qualify, the patient must be willing to undergo randomization into any of 3 trial arms and attend necessary videoconferences. Additionally, they should have been diagnosed with stage I-IIIA breast cancer within 5 years prior, display a clinically significant FCR score at screening, and comprehend English language."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

Shelley Johns 2021. "Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05364450.

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