Cancer Distress Coach Mobile App Trial

November 25, 2019 updated by: Duke University

Cancer Distress Coach Mobile App Randomized Controlled 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™.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

569

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CDC Mobile App Treatment
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.
Behavioral: Cancer Distress Coach Mobile App
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
Other: CDC Mobile App Wait-List Control
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.
Behavioral: Cancer Distress Coach Mobile App
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4, Week 8
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.
Baseline, Week 4, Week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Duke Institute for Health Innovation

Investigators

  • Principal Investigator: Sophia K Smith, PhD, MSW, Duke University School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

April 13, 2019

Study Completion (Actual)

April 13, 2019

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00075411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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