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

Sponsor

Indiana University (Other)

Overall Status

Completed

CT.gov ID

NCT02611544

Collaborator

Indiana University Health (Other)

Enrollment

Location

Arms

Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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:

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.

Study Design

Study Type:

Interventional

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 :

Dec 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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:

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

Outcome Measures

Primary Outcome Measures

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). [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

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). [Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)]
As measured by Concerns about Recurrence Scale (CARS)
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 [Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)]
As measured by Acceptance & Action Questionnaire-Cancer
Change from baseline in anxiety at Post-Intervention, 1-month, and 6-month follow-up as assessed Generalized Anxiety Disorder Scale (GAD-7). [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)
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). [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)
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). [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)
Change from baseline in vitality at Post-Intervention, 1-month, and 6-month follow-up as assessed by Short Form(SF)-36 Vitality Scale. [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
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 [Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)]
As measured by Breast Cancer Self-Efficacy Scale
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 [Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)]
As measured by PROMIS Global Health Scale
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 [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
Change from baseline in mindfulness at Post-Intervention, 1-month, and 6-month follow-up as assessed by Five Facet Mindfulness Questionnaire-Short Form [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
Change from baseline in telomere length at Post-Intervention, 1-month, and 6-month follow-up as assessed by quantitative telomere length. [Baseline (T1), post-intervention/6-weeks (T2), 1-month (T3), and 6-month follow-up (T4)]
As measured by quantitative telomere length.
Intervention ratings for satisfaction and helpfulness at Post-Intervention as assessed by a 5-item investigator-created measure. [post-intervention/6-weeks (T2)]
As measured by a 5-item investigator-created measure of intervention satisfaction and helpfulness

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)