Digital Supportive Care Awareness & Navigation

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

Detailed Description
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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.

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

Conditions
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Supportive Care

Intervention / Treatment
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* Device: D-SCAN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Subjects in the intervention group will receive the D-SCAN mobile application | Device: D-SCAN<br>* 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<br>|
| Other: Control<br>Subjects randomized into the control group will receive standard of care which includes the routine provision of information about supportive care services by nurses and other staff in the DCI clinics, as part of the standard nurse-driven distress screening and management process | Device: D-SCAN<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of enrolled patients complete at least 3 of the 12 symptom surveys over the study duration |  | 12 weeks | 
| Number of patients who complete the exit survey |  | 12 weeks | 
| Number of patients who return the phone |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of use |  | 12 weeks | 
| Duration of use |  | 12 weeks | 
| Session Length |  | 12 weeks | 
| Number of content views |  | 12 weeks | 
| Number of actions taken |  | 12 weeks |