Cancer Distress Coach Mobile App Trial

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Cancer

• Registration Number: NCT02986152
• Lead Sponsor: Duke University

Brief Summary

The Cancer Distress Coach (CDC) mobile app is a symptom management tool for posttraumatic stress disorder (PTSD) in cancer patients and caregivers. Based largely on "PTSD Coach" from the National Center for PTSD, the CDC app was redesigned for both iOS and Android platforms and is tailored specifically to individuals impacted by cancer.

This study aims to evaluate whether CDC app usage influences symptoms of PTSD through a randomized controlled trial (RCT) where subjects are placed into either the intervention group or the wait-listed control group for a period of 8 weeks. The CDC app is available as a free download on the App Store® and on Google Play™.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-08
• Study Start: 2017-06-01
• Primary Completion: 2019-04-13
• Study Completion: 2019-04-13
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-25
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 569

Inclusion Criteria

• Have been diagnosed with cancer or are/were a caregiver to someone with cancer
• Resident of the United States of America
• Able to read and write English
• Age ≥ 18 years

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in PTSD symptoms as measured by the PTSD Checklist (PCL-5)	Baseline, Week 4, Week 8	The PCL-5 is a 20-item self-report symptom checklist that closely mirrors DSM-5 diagnoses criteria. The instructions will be modified so that symptoms are keyed to the particular traumatic stressor of interest; specifically, subjects will be asked to rate each PTSD symptom in the past 4 weeks with respect to their cancer diagnosis and treatment.

Secondary Outcome Measures

Name	Time	Method
Change in stress management self-efficacy as measured by the Self-efficacy questionnaire	Baseline, Week 4, Week 8	The Self-efficacy questionnaire is a 1-item measure of self-efficacy developed by the National Center for PTSD. It rates one's ability to manage the stress of situations reminiscent of the cancer experience on a scale of 0-4, where 0 is not at all able and 4 is extremely able.
Change in distress level as measured by the Distress Thermometer	Baseline, Week 4, Week 8	The Distress Thermometer is used to assess psychosocial distress. It consists of a one-item self-report scale from 0-10, where 0 represents no distress and 10 represents extreme distress.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States