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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03628794
Other study ID # Pro00092123
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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