Cancer Distress Coach Mobile App Trial

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Cancer
• Interventions: Behavioral: Cancer Distress Coach Mobile App

• 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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDC Mobile App Treatment	Cancer Distress Coach Mobile App	Subjects who are randomized to the CDC mobile app treatment arm will be asked to perform the app's full suite of intervention tools such as learning about PTSD, assessment, finding support, and mind/body exercises (e.g., guided imagery, meditation, and relaxation exercises) over the entire 8-week study period.
CDC Mobile App Wait-List Control	Cancer Distress Coach Mobile App	Subjects who are randomized to the CDC mobile app wait-list control arm will be asked to perform only the learning about PTSD, assessment, and finding support activities for the first 4 weeks. Following completion of the Week-4 questionnaires, subjects will then be asked to additionally perform the mind/body exercises (e.g., guided imagery, meditation, and relaxation exercises) for the duration of the 8-week study period.

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