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

NCT02611544 | Completed DMC

• 1 other identifier: IUSCC-0563
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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).

  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 Outcomes (12)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (3)

Acceptance and Commitment Therapy

ACTIVE COMPARATOR

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

Behavioral: Acceptance and Commitment Therapy

Survivorship Education

ACTIVE COMPARATOR

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

Behavioral: Survivorship Education

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

6-week ACT intervention group (n=33)

Also known as: ACT

Acceptance and Commitment Therapy

Survivorship Education BEHAVIORAL

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

Also known as: SE

Survivorship Education

Enhanced Usual Care BEHAVIORAL

enhanced usual care (EUC; n=26)

Also known as: EUC

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• severe depression (PHQ-8 score of ≥ 20),
• past participation in ACT or formal mindfulness training, and
• limited English proficiency.

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Neoplasm Regression, Spontaneous

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shelley A Johns, PsyD

  Indiana University School of Medicine; Regenstrief Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants were blinded to study hypotheses.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Research Scientist

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 20, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 26, 2019

Record last verified: 2019-06

Locations

US (1)