Digital Supportive Care Awareness & Navigation

Supportive Care Clinical Trial

— D-SCAN  

Official title:

Pilot Testing the Digital Supportive Care Awareness & Navigation (D-SCAN) Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628794
• Other study ID #: Pro00092123
• Status: Completed
• Phase: N/A
• Start date: October 25, 2018
• Est. completion date: March 1, 2019

Study information

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

Clinical Trial Summary

To pilot test the feasibility, usability, and preliminary efficacy of the D-SCAN mobile application in cancer patients and caregivers at Duke.

Description:

D-SCAN, a digital patient navigator service in the form of a mobile application ("app"), has been designed at Duke, with feedback from Duke Cancer Institute (DCI) patients, caregivers and clinicians (screenshots in Appendix A).3 Its purpose is to facilitate awareness of available Cancer Patient Support Program (CPSP) services at Duke, and to also help patients recognize their unmet symptom management needs by answering questions from the Edmonton Symptom Assessment Scale (ESAS). This novel electronic system helps to connect patients and their loved ones with existing resources tailored to their unique situations, ensuring that no supportive care needs go unaddressed, thus improving patients' lives and their cancer care.

This protocol aims to assess the feasibility, usability, and preliminary efficacy of the D-SCAN mobile application. The app data, along with quantitative and qualitative feedback obtained during the pilot, will inform future development and design of a subsequent efficacy trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are at least age 18

• Patients who have the capacity to give consent

• Patients with advanced cancer who have initiated treatment at the DCI in the last 12 weeks

• Caregivers over the age of 18 caring for either enrolled or not enrolled patients with advanced cancer who have initiated treatment at the DCI in the last 12 weeks

Exclusion Criteria:

• Patients who are too ill to participate (per clinician discretion)

• Patients not able to read or understand English

Related Conditions & MeSH terms

• Supportive Care

Intervention

Device:
• D-SCAN
Subjects will receive a digital patient navigator service in the form of a mobile application ("app"), which has been designed at Duke, with feedback from Duke Cancer Institute (DCI) patients, caregivers and clinicians. Its purpose is to facilitate awareness of available Cancer Patient Support Program (CPSP) services at Duke, and to also help patients recognize their unmet symptom management needs. Subjects receiving the D-SCAN mobile app will also complete a survey every week within the app. The first 15 patients and 5 caregivers randomized into the intervention arm (those receiving the app) will also be asked to participate in a qualitative interview assessment at week 12, +/- 3 weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of enrolled patients complete at least 3 of the 12 symptom surveys over the study duration		12 weeks
Primary	Number of patients who complete the exit survey		12 weeks
Primary	Number of patients who return the phone		12 weeks
Secondary	Frequency of use		12 weeks
Secondary	Duration of use		12 weeks
Secondary	Session Length		12 weeks
Secondary	Number of content views		12 weeks
Secondary	Number of actions taken		12 weeks