Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Anxiety Disorders

Carcinoma

Breast Neoplasms

Recurrence

Remission, Spontaneous

Neoplasm Regression, Spontaneous

Mammary Neoplasms, Animal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Disease Attributes

Disease Progression

Neoplastic Processes

6 weeks, the ACT group will meet weekly for 2 hours at one of three facilities.

6 weeks, SE group will meet weekly for 2 hours at one of three facilities.

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."

Acceptance and Commitment Therapy

6-week survivorship education group (SE; n=32)

Survivorship Education

Enhanced Usual Care

Shelley A Johns, PsyD

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.

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.

Participants were blinded to study hypotheses.

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

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

As measured by Fear of Cancer Recurrence Inventory (FCRI)

As measured by Concerns about Recurrence Scale (CARS)

As measured by Acceptance \& Action Questionnaire-Cancer

As measured by Generalized Anxiety Disorder Scale (GAD-7)

As measured by Patient Health Questionnaire Depression Scale (PHQ-8)

As measured by Impact of Events Scale-Revised (IES-R)

As measured by Short Form(SF)-36 Vitality Scale

As measured by Breast Cancer Self-Efficacy Scale

As measured by PROMIS Global Health Scale

As measured by Functional Assessment of Chronic Illness Therapy- Spiritual Well-being (FACIT-Sp) scale

As measured by Five Facet Mindfulness Questionnaire-Short Form

As measured by quantitative telomere length.

As measured by a 5-item investigator-created measure of intervention satisfaction and helpfulness

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors	NCT02611544	Breast Neoplasm... Breast Cancer Breast Carcinom... Malignant Neopl... Cancer of Breas... Mammary Neoplas... Human Mammary C... Malignant Tumor... Mammary Cancer Mammary Carcino... Anxiety Fear Neoplasm Remiss... Spontaneous Neo... Regression, Spo... Remission, Spon... Spontaneous Neo...	Acceptance and ... Survivorship Ed... Enhanced Usual ...	18 Years - 99 Years	Indiana University
Investigation of Three Approaches to Address Fear of Recurrence Among Breast Cancer Survivors	NCT02611544	Breast Neoplasm... Breast Cancer Breast Carcinom... Malignant Neopl... Cancer of Breas... Mammary Neoplas... Human Mammary C... Malignant Tumor... Mammary Cancer Mammary Carcino... Anxiety Fear Neoplasm Remiss... Spontaneous Neo... Regression, Spo... Remission, Spon... Spontaneous Neo...	Acceptance and ... Survivorship Ed... Enhanced Usual ...	18 Years - 99 Years	Indiana University

Spots Global Cancer Trial Database for spontaneous neoplasm remission