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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Percentage of eligible BCS who consent to participate in the trial; Attendance rate across 6 sessions of ACT and SE; Retention rate through T4 in the ACT, SE, and EUC arms; 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: Primary outcome: reducing FCR; Secondary psychological outcomes: cancer-related experiential avoidance, cognitive avoidance, anxiety, depression, post-traumatic stress symptoms, vitality, breast cancer self-efficacy, and quality of life; Secondary spiritual outcomes: spiritual well-being and mindfulness; Secondary biological outcome: telomere length.

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

Conditions
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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

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy
* Behavioral: Survivorship Education
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in this study will be eligible if they are: ≥18 years old, have been diagnosed with non-metastatic breast cancer (stages I-III), have completed curative treatment for breast cancer, have not experienced a cancer recurrence, and 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: severe depression (PHQ-8 score of ≥ 20), past participation in ACT or formal mindfulness training, and limited English proficiency.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acceptance and Commitment Therapy<br>6 weeks, the ACT group will meet weekly for 2 hours at one of three facilities. | Behavioral: Acceptance and Commitment Therapy<br>* 6-week ACT intervention group (n=33)<br>* Other names: ACT;|
| Active Comparator: Survivorship Education<br>6 weeks, SE group will meet weekly for 2 hours at one of three facilities. | Behavioral: Survivorship Education<br>* 6-week survivorship education group (SE; n=32)<br>* Other names: SE;|
| Active Comparator: Enhanced Usual Care<br>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<br>* enhanced usual care (EUC; n=26)<br>* Other names: EUC;|

What is the study measuring?
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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). | 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). | 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 | 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). | 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). | 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). | 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. | 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 | 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 | 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 | 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 | 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. | 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. | As measured by a 5-item investigator-created measure of intervention satisfaction and helpfulness | post-intervention/6-weeks (T2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fear of Cancer Recurrence, Fear of Cancer Return, Breast Cancer Survivor, Breast Cancer Remission