Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors

June 25, 2019 updated by: Shelley Johns, Indiana University

Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors: A Randomized Clinical Pilot Trial

Fear of cancer recurrence (FCR) is one of the most prevalent, persistent, and disruptive sources of distress for adult cancer survivors. Prevalence rates for FCR have been estimated at up to 89%, with approximately half of cancer survivors reporting clinically significant levels of FCR. Despite the recognized prevalence, persistence, and suffering associated with FCR, effective and accessible treatments for FCR are lacking and urgently needed. Our long-term goal is to develop, evaluate, and implement effective behavioral interventions for cancer survivors suffering with FCR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed randomized pilot study will assess the effects of a novel therapeutic intervention-Acceptance and Commitment Therapy (ACT)-for breast cancer survivors (BCS) with clinically-significant FCR. ACT is a spiritually-sensitive behavioral therapy that has shown efficacy in the treatment of anxiety in non-cancer populations, and preliminary efficacy in improving a variety of outcomes among adults with cancer. ACT uses mindfulness and acceptance processes, along with committed behavior change in service of an individual's deeply held values to enhance psychological flexibility and encourage adaptive coping with life challenges, such as cancer.

The primary objective of the proposed 3-arm randomized controlled pilot trial is to assess the feasibility/acceptability and determine preliminary effect size estimates of ACT in preparation for a fully-powered efficacy trial. To allow for potential drop out (15% attrition) and ensure we have a minimum of 78 completers through the end of the trial, we will enroll approximately 91 BCS with clinically significant FCR (defined by score ≥ 13 on Fears of Cancer Recurrence Inventory-Short Form). Participants will be randomized to one of three groups: (1) a 6-week ACT intervention group (n=26); (2) a 6-week survivorship education group (SE; n=26); or (3) enhanced usual care (EUC; n=26). The impact of ACT, SE, and EUC on survivors' FCR and associated psychological, spiritual, and biological (telomere length) outcomes will be examined at baseline (T1), post-intervention (T2), and at 1-month (T3) and 6-month follow-up (T4) with the following specific aims:

Aim 1: Evaluate feasibility and acceptability of ACT, SE, and EUC according to the:

  1. Percentage of eligible BCS who consent to participate in the trial;
  2. Attendance rate across 6 sessions of ACT and SE;
  3. Retention rate through T4 in the ACT, SE, and EUC arms;
  4. Mean ratings across groups for intervention satisfaction and helpfulness for managing FCR.

Aim 2: Determine pairwise effect size estimates of ACT, SE, and EUC effects at each time point (T2, T3, T4) adjusted for T1 on the:

  1. Primary outcome: reducing FCR;
  2. Secondary psychological outcomes: cancer-related experiential avoidance, cognitive avoidance, anxiety, depression, post-traumatic stress symptoms, vitality, breast cancer self-efficacy, and quality of life;
  3. Secondary spiritual outcomes: spiritual well-being and mindfulness;
  4. Secondary biological outcome: telomere length.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: Participants in this study will be eligible if they are:

  1. ≥18 years old,
  2. have been diagnosed with non-metastatic breast cancer (stages I-III),
  3. have completed curative treatment for breast cancer,
  4. have not experienced a cancer recurrence, and
  5. report a clinically significant level of FCR (Fear of Cancer Recurrence Inventory-Short Form score of ≥ 13)

Exclusion Criteria: Participants in this study will be ineligible if they are:

  1. severe depression (PHQ-8 score of ≥ 20),
  2. past participation in ACT or formal mindfulness training, and
  3. limited English proficiency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acceptance and Commitment Therapy
6 weeks, the ACT group will meet weekly for 2 hours at one of three facilities.
Behavioral: Acceptance and Commitment Therapy
6-week ACT intervention group (n=33)
Other Names:
  • ACT
Active Comparator: Survivorship Education
6 weeks, SE group will meet weekly for 2 hours at one of three facilities.
Behavioral: Survivorship Education
6-week survivorship education group (SE; n=32)
Other Names:
  • SE
Active Comparator: Enhanced Usual Care
Continue to meet with their health care team + receive a variety of readings at each data collection point on coping with common survivorship concerns, including a booklet from the National Cancer Institute entitled "Facing Forward: Life After Cancer Treatment."
Behavioral: Enhanced Usual Care
enhanced usual care (EUC; n=26)
Other Names:
  • EUC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in fear of recurrence (FCR) at Post-Intervention, 1-month, and 6-month follow-up as assessed by Fear of Cancer Recurrence Inventory (FCRI).
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by Fear of Cancer Recurrence Inventory (FCRI)
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in fear of recurrence (FCR) at Post-Intervention, 1-month, and 6-month follow-up as assessed by Concerns about Recurrence Scale (CARS).
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by Concerns about Recurrence Scale (CARS)
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Change from baseline in cancer-related avoidant coping at Post-Intervention, 1-month, and 6-month follow-up as assessed by Acceptance & Action Questionnaire-Cancer
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by Acceptance & Action Questionnaire-Cancer
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Change from baseline in anxiety at Post-Intervention, 1-month, and 6-month follow-up as assessed Generalized Anxiety Disorder Scale (GAD-7).
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by Generalized Anxiety Disorder Scale (GAD-7)
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Change from baseline in depression at Post-Intervention, 1-month, and 6-month follow-up as assessed by as measured by Patient Health Questionnaire Depression Scale (PHQ-8).
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by Patient Health Questionnaire Depression Scale (PHQ-8)
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Change from baseline in post-traumatic stress symptoms at Post-Intervention, 1-month, and 6-month follow-up as assessed by Impact of Events Scale-Revised (IES-R).
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by Impact of Events Scale-Revised (IES-R)
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Change from baseline in vitality at Post-Intervention, 1-month, and 6-month follow-up as assessed by Short Form(SF)-36 Vitality Scale.
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by Short Form(SF)-36 Vitality Scale
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Change from baseline in Breast Cancer Self-Efficacy at Post-Intervention, 1-month, and 6-month follow-up as assessed by Breast Cancer Self-Efficacy Scale
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by Breast Cancer Self-Efficacy Scale
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Change from baseline in quality of life at Post-Intervention, 1-month, and 6-month follow-up as assessed by 10-item PROMIS Global Health Scale
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by PROMIS Global Health Scale
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Change from baseline in spiritual well-being at Post-Intervention, 1-month, and 6-month follow-up as assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-being (FACIT-Sp) scale
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by Functional Assessment of Chronic Illness Therapy- Spiritual Well-being (FACIT-Sp) scale
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Change from baseline in mindfulness at Post-Intervention, 1-month, and 6-month follow-up as assessed by Five Facet Mindfulness Questionnaire-Short Form
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by Five Facet Mindfulness Questionnaire-Short Form
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Change from baseline in telomere length at Post-Intervention, 1-month, and 6-month follow-up as assessed by quantitative telomere length.
Time Frame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
As measured by quantitative telomere length.
Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Intervention ratings for satisfaction and helpfulness at Post-Intervention as assessed by a 5-item investigator-created measure.
Time Frame: post-intervention/6-weeks (T2)
As measured by a 5-item investigator-created measure of intervention satisfaction and helpfulness
post-intervention/6-weeks (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Indiana University Health

Investigators

  • Principal Investigator: Shelley A Johns, PsyD, Indiana University School of Medicine; Regenstrief Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUSCC-0563

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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