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

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ClinicalTrials.gov Identifier: NCT02611544
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
Indiana University Health
Information provided by (Responsible Party):
Shelley Johns, Indiana University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Cancer Breast Carcinoma Malignant Neoplasm of Breast Cancer of Breast Mammary Neoplasm, Human Human Mammary Carcinoma Malignant Tumor of Breast Mammary Cancer Mammary Carcinoma Anxiety Fear Neoplasm Remission, Spontaneous Spontaneous Neoplasm Regression Regression, Spontaneous Neoplasm Remission, Spontaneous Neoplasm Spontaneous Neoplasm Remission Behavioral: Acceptance and Commitment Therapy Behavioral: Survivorship Education Behavioral: Enhanced Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Masking Description: Participants were blinded to study hypotheses.
Primary Purpose: Health Services Research
Official Title: Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors: A Randomized Clinical Pilot Trial
Study Start Date : December 2015
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: EUC




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611544


Locations
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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Indiana University Health
Investigators
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Principal Investigator: Shelley A Johns, PsyD Indiana University School of Medicine; Regenstrief Institute, Inc.

Publications:
Watson M, Law, M.G., Santos, M.D., Greer, S., Baruch, J., Bliss, J. . The Mini-MAC. J Psychosoc Oncol. 1994;12(3):33-46.
Weiss D, Marmar C. The Impact of Event Scale-Revised. In: Wilson J, Keane T, editors. Assessing psychological trauma and PTSD: A practicioner's handbook. New York: Guilford Press; 1997. p. 399-411.
Ware J, Snow K, Kosinski M. SF-36 healthy survey manual and interpretation guide. Lincoln, RI: Quality Metric Inc.; 1993.

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Responsible Party: Shelley Johns, Assistant Professor of Medicine, Research Scientist, Indiana University
ClinicalTrials.gov Identifier: NCT02611544     History of Changes
Other Study ID Numbers: IUSCC-0563
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shelley Johns, Indiana University:
Fear of Cancer Recurrence
Fear of Cancer Return
Breast Cancer Survivor
Breast Cancer Remission
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Mammary Neoplasms, Animal
Neoplasm Regression, Spontaneous
Recurrence
Remission, Spontaneous
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Disease Progression
Neoplastic Processes