Cancer Distress Coach Mobile App Trial
1 other identifier
interventional
569
1 country
1
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™.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2016
CompletedFirst Posted
Study publicly available on registry
December 8, 2016
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2019
CompletedNovember 26, 2019
November 1, 2019
1.9 years
December 6, 2016
November 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in PTSD symptoms as measured by the PTSD Checklist (PCL-5)
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.
Baseline, Week 4, Week 8
Secondary Outcomes (2)
Change in distress level as measured by the Distress Thermometer
Baseline, Week 4, Week 8
Change in stress management self-efficacy as measured by the Self-efficacy questionnaire
Baseline, Week 4, Week 8
Other Outcomes (1)
Feasibility as measured by satisfaction with the Cancer Distress Coach mobile app, as measured by the Feedback questionnaire
Week 4, Week 8
Study Arms (2)
CDC Mobile App Treatment
EXPERIMENTALSubjects 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
OTHERSubjects 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.
Interventions
Cancer Distress Coach is a stand-alone symptom management tool with three basic components. The Learn about Distress module provides psycho-education. The Insights module includes an inspiring Quote of the Day, daily activity planning tips, a graph displaying the user's distress level plotted over time, and assessment feedback. The main action of the application is in the Activities module that provides patients with skills to manage their stress in the moment they experience it. Depending on the severity, the patient is routed to any of a number of helpful skills based on cognitive-behavioral principles. The stress management tools include positive imageries, soothing songs and pictures, and the Relax-Identify-Decide tool. Also included is "find support" and "get support now" to connect the user to his/her support network and locate informal cancer and non-cancer related support or (immediate) professional care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Duke Institute for Health Innovationcollaborator
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophia K Smith, PhD, MSW
Duke University School of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2016
First Posted
December 8, 2016
Study Start
June 1, 2017
Primary Completion
April 13, 2019
Study Completion
April 13, 2019
Last Updated
November 26, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share