NCT03628794

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 18, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

August 10, 2018

Last Update Submit

July 17, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

Intervention

OTHER

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

Device: D-SCAN

Control

OTHER

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

Interventions

D-SCANDEVICE

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

ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who are too ill to participate (per clinician discretion)
  • Patients not able to read or understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Cancer Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 14, 2018

Study Start

October 25, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

July 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

No IPD will be shared

Locations