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Completed

NCT Number: NCT02986152

Cancer Distress Coach Mobile App Trial

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™.

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Key information

Conditions

Posttraumatic Stress Disorder Alzheimer Disease Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Cancer Central Nervous System Diseases Dementia Depression Mental Disorders Neoplasms Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Tauopathies Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cancer Distress Coach Mobile App

Behavioral

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.

Other names: CDC Mobile App

Primary outcomes

  1. Change in PTSD symptoms as measured by the PTSD Checklist (PCL-5)

    Time frame: 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 outcomes

  1. Change in distress level as measured by the Distress Thermometer

    Time frame: 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.

  2. Change in stress management self-efficacy as measured by the Self-efficacy questionnaire

    Time frame: 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.

Other outcomes

  1. Feasibility as measured by satisfaction with the Cancer Distress Coach mobile app, as measured by the Feedback questionnaire

    Time frame: Week 4, Week 8

    The Feedback questionnaire was developed by the study team to assess perceived helpfulness of the app and user satisfaction with the app. Points are totaled and summed.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Duke Institute for Health Innovation

Registry information

Official study title

Cancer Distress Coach Mobile App Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 8, 2016
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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