Expired Study
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Indianapolis, Indiana 46202


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

IUSCC-0563


NCT ID:

NCT02611544


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

99 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

91


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:December 2015
Completion Date:December 1, 2016
Completion Type:Actual
Primary Completion Date:December 1, 2016
Primary Completion Type:Actual
Verification Date:June 2019
Last Changed Date:June 25, 2019
First Received Date:November 16, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by a 5-item investigator-created measure of intervention satisfaction and helpfulness
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by quantitative telomere length.
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by Five Facet Mindfulness Questionnaire-Short Form
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by Functional Assessment of Chronic Illness Therapy- Spiritual Well-being (FACIT-Sp) scale
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by PROMIS Global Health Scale
Outcome Type:Primary Outcome
Measure: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)
Safety Issues:False
Description:As measured by Fear of Cancer Recurrence Inventory (FCRI)
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by Breast Cancer Self-Efficacy Scale
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by Short Form(SF)-36 Vitality Scale
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by Impact of Events Scale-Revised (IES-R)
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by Patient Health Questionnaire Depression Scale (PHQ-8)
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by Generalized Anxiety Disorder Scale (GAD-7)
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by Acceptance & Action Questionnaire-Cancer
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:As measured by Concerns about Recurrence Scale (CARS)

Study Interventions

Intervention Type:Behavioral
Name:Acceptance and Commitment Therapy
Description:6-week ACT intervention group (n=33)
Arm Name:Acceptance and Commitment Therapy
Other Name:ACT
Intervention Type:Behavioral
Name:Survivorship Education
Description:6-week survivorship education group (SE; n=32)
Arm Name:Survivorship Education
Other Name:SE
Intervention Type:Behavioral
Name:Enhanced Usual Care
Description:enhanced usual care (EUC; n=26)
Arm Name:Enhanced Usual Care
Other Name:EUC

Study Arms

Study Arm Type:Active Comparator
Arm Name:Acceptance and Commitment Therapy
Description:6 weeks, the ACT group will meet weekly for 2 hours at one of three facilities.
Study Arm Type:Active Comparator
Arm Name:Survivorship Education
Description:6 weeks, SE group will meet weekly for 2 hours at one of three facilities.
Study Arm Type:Active Comparator
Arm Name:Enhanced Usual Care
Description: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."

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Indiana University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Indiana University Health

Sample and Retention Information

There are no available Sample and Retention Information

Study References

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PMID:23475398
Reference Type:Reference
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PMID:22232030
Reference Type:Reference
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PMID:12581932
Reference Type:Reference
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PMID:25178165
Reference Type:Reference
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Reference Type:Reference
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PMID:19235193
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PMID:24756313
Reference Type:Reference
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PMID:23617696
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PMID:25547522
Reference Type:Reference
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Reference Type:Reference
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Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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