Digital Supportive Care Awareness & Navigation

NCT ID: NCT03628794

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-25

Study Completion Date

2019-03-01

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.

Conditions

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Supportive Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Subjects in the intervention group will receive the D-SCAN mobile application

Group Type OTHER

D-SCAN

Intervention Type DEVICE

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

Control

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

Group Type OTHER

D-SCAN

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Duke University Cancer Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35718794 (View on PubMed)

Other Identifiers

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Pro00092123

Identifier Type: -

Identifier Source: org_study_id

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