Supportive CareD-SCANNCT03628794
Digital Supportive Care Awareness & Navigation
A study testing D-SCAN in people with Supportive Care, run by Duke University at 1 site in United States.
Trial summary
To pilot test the feasibility, usability, and preliminary efficacy of the D-SCAN mobile application in cancer patients and caregivers at Duke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supportive Care
- What is being tested?
- D-SCAN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are too ill to participate (per clinician discretion)
- Patients not able to read or understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Cancer Center
Durham, North Carolina, 27705
About this study
Official title: Pilot Testing the Digital Supportive Care Awareness & Navigation (D-SCAN) Application
To pilot test the feasibility, usability, and preliminary efficacy of the D-SCAN mobile application in cancer patients and caregivers at Duke.
Read the 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.
- Conditions
- Supportive Care
- Being tested
- D-SCAN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Subjects in the intervention group will receive the D-SCAN mobile application Receives: 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 Receives: Device: D-SCAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of enrolled patients complete at least 3 of the 12 symptom surveys over the study duration
Measured: 12 weeks
Number of patients who complete the exit survey
Measured: 12 weeks
Number of patients who return the phone
Measured: 12 weeks
Secondary outcomes (5)
Frequency of use
Measured: 12 weeks
Duration of use
Measured: 12 weeks
Session Length
Measured: 12 weeks
Number of content views
Measured: 12 weeks
Number of actions taken
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start25 Oct 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supportive CareStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628794
- Sponsor's protocol ID
- Pro00092123
- Acronym
- D-SCAN
- Status last verified
- Apr 2019
- First submitted
- 10 Aug 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Publications
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.
PubMed 35718794
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing the Digital Supportive Care Awareness & Navigation (D-SCAN) Application
- ClinicalTrials.gov ID
- NCT03628794
- Acronym / sponsor ID
- D-SCAN / Pro00092123
- Conditions
- Supportive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Device: D-SCANSubjects in the intervention group will receive the D-SCAN mobile application |
| Control | Other | Device: D-SCANSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are too ill to participate (per clinician discretion)
- Patients not able to read or understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-SCANSubjects 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 | Device | Control, Intervention |
Primary outcome
Number of enrolled patients complete at least 3 of the 12 symptom surveys over the study duration
Time frame: 12 weeks
Number of patients who complete the exit survey
Time frame: 12 weeks
Number of patients who return the phone
Time frame: 12 weeks
5 secondary outcomes
Frequency of use
Time frame: 12 weeks
Duration of use
Time frame: 12 weeks
Session Length
Time frame: 12 weeks
Number of content views
Time frame: 12 weeks
Number of actions taken
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Derived from this study: PubMed 35718794Merz 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.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-SCAN in people with Supportive Care, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of enrolled patients complete at least 3 of the 12 symptom surveys over the study duration (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03628794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019; AzTrials last refreshed its copy on 27 Oct 2026.