Clinical trial NCT03628794: Digital Supportive Care Awareness & Navigation
Official title: Pilot Testing the Digital Supportive Care Awareness & Navigation (D-SCAN) Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supportive Care
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2018-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of enrolled patients complete at least 3 of the 12 symptom surveys over the study duration
timeFrame: 12 weeks
measure: Number of patients who complete the exit survey
timeFrame: 12 weeks
measure: Number of patients who return the phone
timeFrame: 12 weeks
Secondary outcomes:
measure: Frequency of use
timeFrame: 12 weeks
measure: Duration of use
timeFrame: 12 weeks
measure: Session Length
timeFrame: 12 weeks
measure: Number of content views
timeFrame: 12 weeks
measure: Number of actions taken
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Cancer Center
state: North Carolina
Study officials:
References:
citation: Merz A, Mohamed A, Corbett C, Herring K, Hildenbrand J, Locke SC, Patierno S, Troy J, Wolf S, Zafar SY, Chilcott J, Higgins A, Manassei H, McCoy C, Buckingham TL, LeBlanc TW. A single-site pilot feasibility randomized trial of a supportive care mobile application intervention for patients with advanced cancer and caregivers. Support Care Cancer. 2022 Oct;30(10):7853-7861. doi: 10.1007/s00520-022-07224-x. Epub 2022 Jun 20.