Clinical trial NCT02611544: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: Fear of Cancer Recurrence
Fear of Cancer Return
Breast Cancer Survivor
Breast Cancer Remission
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University Health
First posted: 2015-11-20
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
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).
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
Secondary outcomes:
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).
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
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
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
measure: Change from baseline in anxiety at Post-Intervention, 1-month, and 6-month follow-up as assessed Generalized Anxiety Disorder Scale (GAD-7).
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
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).
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
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).
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
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.
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
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
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
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
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
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
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
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
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
measure: Change from baseline in telomere length at Post-Intervention, 1-month, and 6-month follow-up as assessed by quantitative telomere length.
timeFrame: Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)
measure: Intervention ratings for satisfaction and helpfulness at Post-Intervention as assessed by a 5-item investigator-created measure.
timeFrame: post-intervention/6-weeks (T2)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine; Regenstrief Institute, Inc.
name: Shelley A Johns, PsyD
role: PRINCIPAL_INVESTIGATOR
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