CancerNCT03459352
Digital Symptom Tracking, Patient Engagement and Quality of Life in GI Oncology Clinic Patients
A study testing ePRO in people with Cancer, run by Duke University at 1 site in United States.
Trial summary
A pilot study of an ePRO system in cancer patients receiving systemic therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- ePRO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2018to 4 Apr 2020
- 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
- Individuals (men and women) aged 18 years or older
- History cancer with no limitation on prior lines of therapy in the metastatic setting
- ECOG performance status of 0-2
- Estimated life expectancy of at least 12 months
- Access to smartphone, tablet or computer with capability to utilize symptom-tracking application
- Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
- Willing and able to comply with all study procedures
Who cannot join
- Concurrent disease or condition that interferes with participation or safety
- Non-English speaking, as the application is developed in the English language
- Children will not be included in the study. The pattern of disease and symptoms are different in children than in an adult population. The web-based tool was designed based on the symptom experience of adults with cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Feasibility Study of Digital Symptom Tracking, Patient Engagement and Quality of Life in Patients Seen in GI Oncology Clinic
A pilot study of an ePRO system in cancer patients receiving systemic therapies.
Read the detailed description
The primary purpose of this pilot study is to determine the feasibility of the Noona Healthcare Mobile PRO Application to describe oncology patient engagement using a web-based symptom self-monitoring instrument. Additionally, the studyy will dentify side effects as well as long term or chronic adverse events during and following cancer therapy based on the United States (US) National Cancer Institute (NCI) Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), and identify patients to participate in future long-term Quality of Life studies following cancer therapy.
The study is not intended to compare outcomes between groups receiving different therapies.
- Conditions
- Cancer
- Being tested
- ePRO
- Keywords
- Cancer, Patient Reported Outcomes, Symptom management
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePROOther
Also called Noona web-based platform
Patients will be instructed to log symptoms with an ePRO app using their own personal devices, and prompted once per month for 12 months to log symptoms.
These participants will be sent an Adverse Event Questionnaire (AEQ) via the Noona tool that summarizes their symptoms and distress once per month and one week prior to any medically indicated oncology clinic visit.
Symptoms designated as clinically severe either during regular symptom logging or via the AEQ will trigger a prompt to contact the clinical team for immediate follow-up. Participants will complete a follow-up questionnaire at 6 months and 12 months following enrollment that includes a self-report of symptom burden, HRQOL, and satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| ePRO | Experimental | There is no therapeutic intervention. Patients will use ePRO system to report systems. We will describe use in patients to determine compliance in reporting symptoms. Receives: Other: ePRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject participation
total number of subjects that participate in the use of a web-based system
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start18 Jun 2018
- Primary completion4 Apr 2020
- Study completion4 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Noona Healthcare Inc
- Responsible party
- Sponsor
- Investigators
- H. Kim Lyerly, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459352
- Sponsor's protocol ID
- Pro00092471
- Status last verified
- Sep 2019
- First submitted
- 2 Mar 2018
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Digital Symptom Tracking, Patient Engagement and Quality of Life in Patients Seen in GI Oncology Clinic
- ClinicalTrials.gov ID
- NCT03459352
- Acronym / sponsor ID
- Pro00092471
- Conditions
- Cancer
- Keywords
- Cancer, Patient Reported Outcomes, Symptom management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Noona Healthcare Inc
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 4 Apr 2020 (actual)
- Study completion
- 4 Apr 2020 (actual)
- First posted
- 8 Mar 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.
A pilot study of an ePRO system in cancer patients receiving systemic therapies.
Detailed description
The primary purpose of this pilot study is to determine the feasibility of the Noona Healthcare Mobile PRO Application to describe oncology patient engagement using a web-based symptom self-monitoring instrument. Additionally, the studyy will dentify side effects as well as long term or chronic adverse events during and following cancer therapy based on the United States (US) National Cancer Institute (NCI) Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), and identify patients to participate in future long-term Quality of Life studies following cancer therapy.
The study is not intended to compare outcomes between groups receiving different therapies.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ePRO | Experimental | Other: ePROThere is no therapeutic intervention. Patients will use ePRO system to report systems. We will describe use in patients to determine compliance in reporting symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals (men and women) aged 18 years or older
- History cancer with no limitation on prior lines of therapy in the metastatic setting
- ECOG performance status of 0-2
- Estimated life expectancy of at least 12 months
- Access to smartphone, tablet or computer with capability to utilize symptom-tracking application
Key exclusion criteria (3 listed)
- Concurrent disease or condition that interferes with participation or safety
- Non-English speaking, as the application is developed in the English language
- Children will not be included in the study. The pattern of disease and symptoms are different in children than in an adult population. The web-based tool was designed based on the symptom experience of adults with cancer.
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 |
|---|---|---|
| ePROAlso: Noona web-based platformPatients will be instructed to log symptoms with an ePRO app using their own personal devices, and prompted once per month for 12 months to log symptoms. These participants will be sent an Adverse Event Questionnaire (AEQ) via the Noona tool that summarizes their symptoms and distress once per month and one week prior to any medically indicated oncology clinic visit. Symptoms designated as clinically severe either during regular symptom logging or via the AEQ will trigger a prompt to contact the clinical team for immediate follow-up. Participants will complete a follow-up questionnaire at 6 months and 12 months following enrollment that includes a self-report of symptom burden, HRQOL, and satisfaction. | Other | ePRO |
Primary outcome
Subject participation
Time frame: 12 months
total number of subjects that participate in the use of a web-based system
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 26 Aug 2020.
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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.
H. Kim Lyerly, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePRO in people with Cancer, 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 7 inclusion and 3 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 26 Aug 2020. 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?
Subject participation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2020.