Cancer Distress Coach Mobile App Trial

Cancer Clinical Trial

Official title:

Cancer Distress Coach Mobile App Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986152
• Other study ID #: Pro00075411
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: April 13, 2019

Study information

• Verified date: November 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 569
• Est. completion date: April 13, 2019
• Est. primary completion date: April 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Duke Institute for Health Innovation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility as measured by satisfaction with the Cancer Distress Coach mobile app, as measured by the Feedback questionnaire	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
Primary	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	Change in distress level as measured by the Distress Thermometer	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
Secondary	Change in stress management self-efficacy as measured by the Self-efficacy questionnaire	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