Advanced CancerELOSNCT03532997
Extra Layer Of Support
A study testing ELOS in people with Advanced Cancer and Palliative Care, run by Duke University at 1 site in United States.
Trial summary
The investigators aim to introduce patients with advanced cancer to supportive care resources, including specialty palliative care, through a novel app called "ELOS" (stands for "extra layer of support) in a prospective cohort study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Palliative Care
- What is being tested?
- ELOS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 7 Jan 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
- Age >18
- capacity to give consent
- has received a diagnosis of Stage IV solid tumor malignancy or Stage III pancreas or lung cancer within the 8 weeks prior to consent
- ability to speak and understand English
- has access to a computer and the internet
Who cannot join
- Not Age 18 or older
- Does not have capacity to give consent
- Has not received a diagnosis of Stage IV solid tumor malignancy or Stage III pancreas or lung cancer within the 8 weeks prior to consent
- Does not have the ability to speak and understand English
- Does not have access to a computer and the internet
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center - Cancer Prevention, Detection and Control
Durham, North Carolina, 27710
About this study
Official title: Developing and Testing a Web-based Tool to Engage Advanced Cancer Patients in Palliative Care (ēlos)
The investigators aim to introduce patients with advanced cancer to supportive care resources, including specialty palliative care, through a novel app called "ELOS" (stands for "extra layer of support) in a prospective cohort study. The investigators will compare participant acceptance of this new electronic tool to industry standards and follow ultimate referrals to outpatient palliative care compared to historical, matched controls.
Read the detailed description
The investigators will conduct a prospective cohort study to investigate usability of implementing Ēlos across 50 advanced cancer patients within the Duke Cancer Institute and University of North Carolina - Chapel Hill Cancer Center. The investigators will obtain a Data Transfer Agreement prior to enrollment at the University of North Carolina. Usability testing evaluates a technology system's capacity for practical implementation in the field including logistical, social, financial, regulatory, and time considerations. The Usability test will also build foundational data needed to design a future, multi-site controlled trial evaluating the efficacy of Ēlos alongside exploring real-world implementation issues to address prior to undertaking the larger trial.
To conduct the study, the investigators will consecutively approach two populations: adult advanced cancer patients (defined as any Stage IV solid tumor malignancy, or Stage III pancreas or lung cancer) in the GI, GU, and Thoracic Cancer Clinics with a diagnosis made in the preceding eight weeks. The investigators will primarily evaluate usability through evaluating subject-reported perceived usefulness. .
The investigators will also measure change in patient self-efficacy and change knowledge of palliative care scores alongside obtaining baseline data on palliative care referral rates.
To evaluate perceived usefulness, the investigators will use the Perceived Usefulness Scale and Ease of Use subscales of the System Usability Scale, common tools used in health technology evaluations30 and a single item "I feel prepared for the palliative care visit".
Lastly, the investigators will measure subsequent referrals to palliative care, comparing the Ēlos cohort with a non-intervention cohort. the investigators will compare three cohorts: 1). Ēlos intervention cohort; 2). An age-, disease-, and stage-matched cohort of usual care patients during the same time period as the intervention; and 3). A similarly-matched cohort who received usual oncology care six months prior to the study. The latter control cohort evaluates palliative care referral practices prior to any intervention taking place to reduce contamination. The investigators will use these preliminary data on referral rates to determine the effect sizes needed to calculate the sample sizes for an Alliance CCDR protocol for a NCORP trial.
- Conditions
- Advanced Cancer, Palliative Care
- Being tested
- ELOS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELOSOther
The investigators aim to introduce patients with advanced cancer to supportive care resources, including specialty palliative care, through a novel web-based application called "ELOS" (stands for "extra layer of support) in a prospective cohort study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The investigators aim to introduce patients with advanced cancer to supportive care resources, including specialty palliative care, through a novel app called "ELOS" (stands for "extra layer of support) in a prospective cohort study. The investigators will compare participant acceptance of this new electronic tool to industry standards and follow ultimate referrals to outpatient palliative care compared to historical, matched controls. Receives: Other: ELOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability as measured by the System Usability Scale
The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
Measured: Up to one hour
Validity as measured by the symptom assessment module
Measured: Up to one hour
Change in Palliative Care referral
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start1 Oct 2018
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532997
- Sponsor's protocol ID
- Pro00089227
- Acronym
- ELOS
- Status last verified
- Feb 2020
- First submitted
- 10 May 2018
- Last updated
- 26 Feb 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 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Web-based Tool to Engage Advanced Cancer Patients in Palliative Care (ēlos)
- ClinicalTrials.gov ID
- NCT03532997
- Acronym / sponsor ID
- ELOS / Pro00089227
- Conditions
- Advanced Cancer, Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 22 May 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.
The investigators aim to introduce patients with advanced cancer to supportive care resources, including specialty palliative care, through a novel app called "ELOS" (stands for "extra layer of support) in a prospective cohort study. The investigators will compare participant acceptance of this new electronic tool to industry standards and follow ultimate referrals to outpatient palliative care compared to historical, matched controls.
Detailed description
The investigators will conduct a prospective cohort study to investigate usability of implementing Ēlos across 50 advanced cancer patients within the Duke Cancer Institute and University of North Carolina - Chapel Hill Cancer Center. The investigators will obtain a Data Transfer Agreement prior to enrollment at the University of North Carolina. Usability testing evaluates a technology system's capacity for practical implementation in the field including logistical, social, financial, regulatory, and time considerations. The Usability test will also build foundational data needed to design a future, multi-site controlled trial evaluating the efficacy of Ēlos alongside exploring real-world implementation issues to address prior to undertaking the larger trial.
To conduct the study, the investigators will consecutively approach two populations: adult advanced cancer patients (defined as any Stage IV solid tumor malignancy, or Stage III pancreas or lung cancer) in the GI, GU, and Thoracic Cancer Clinics with a diagnosis made in the preceding eight weeks. The investigators will primarily evaluate usability through evaluating subject-reported perceived usefulness. .
The investigators will also measure change in patient self-efficacy and change knowledge of palliative care scores alongside obtaining baseline data on palliative care referral rates.
To evaluate perceived usefulness, the investigators will use the Perceived Usefulness Scale and Ease of Use subscales of the System Usability Scale, common tools used in health technology evaluations30 and a single item "I feel prepared for the palliative care visit".
Lastly, the investigators will measure subsequent referrals to palliative care, comparing the Ēlos cohort with a non-intervention cohort. the investigators will compare three cohorts: 1). Ēlos intervention cohort; 2). An age-, disease-, and stage-matched cohort of usual care patients during the same time period as the intervention; and 3). A similarly-matched cohort who received usual oncology care six months prior to the study. The latter control cohort evaluates palliative care referral practices prior to any intervention taking place to reduce contamination. The investigators will use these preliminary data on referral rates to determine the effect sizes needed to calculate the sample sizes for an Alliance CCDR protocol for a NCORP trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: ELOSThe investigators aim to introduce patients with advanced cancer to supportive care resources, including specialty palliative care, through a novel app called "ELOS" (stands for "extra layer of support) in a prospective cohort study. The investigators will compare participant acceptance of this new electronic tool to industry standards and follow ultimate referrals to outpatient palliative care compared to historical, matched controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18
- capacity to give consent
- has received a diagnosis of Stage IV solid tumor malignancy or Stage III pancreas or lung cancer within the 8 weeks prior to consent
- ability to speak and understand English
- has access to a computer and the internet
Key exclusion criteria (5 listed)
- Not Age 18 or older
- Does not have capacity to give consent
- Has not received a diagnosis of Stage IV solid tumor malignancy or Stage III pancreas or lung cancer within the 8 weeks prior to consent
- Does not have the ability to speak and understand English
- Does not have access to a computer and the internet
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 |
|---|---|---|
| ELOSThe investigators aim to introduce patients with advanced cancer to supportive care resources, including specialty palliative care, through a novel web-based application called "ELOS" (stands for "extra layer of support) in a prospective cohort study. | Other | Intervention |
Primary outcome
Usability as measured by the System Usability Scale
Time frame: Up to one hour
The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
Validity as measured by the symptom assessment module
Time frame: Up to one hour
Change in Palliative Care referral
Time frame: Baseline
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 Feb 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.
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 ELOS in people with Advanced Cancer and Palliative 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 5 inclusion and 5 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 Feb 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?
Usability as measured by the System Usability Scale (time frame: Up to one hour). 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?
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 Feb 2020.