GI CancerNCT03676426
Comparison of a Web-based Advance Directive to a Standard Advance Directive
A study testing Web platform for advance care planning/advance directive and Standard advance directive in people with GI Cancer and Thoracic Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will compare a web-based advance directive to a standard advance directive. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- GI Cancer, Thoracic Cancer
- What is being tested?
- Web platform for advance care planning/advance directive and Standard advance directive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 20 Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pancreatic cancer, any stage except stage 0 (C25),
- NSCLC, stage IIIA or higher (C34),
- SCLC, any stage (C34),
- Colon cancer, stage IIIB or greater (C18),
- Rectal cancer, stage IIB or greater (C21),
- Esophageal cancer (adeno or squamous), any stage (C15),
Show all 11Show fewer
- Stomach cancer, stage IIB or greater (C16),
- Gallbladder cancer, stage I or greater (C23),
- Cholangiocarcinoma, any stage (C22.1),
- HCC, any stage (no plan for transplant) (C22.0),
- Malignant carcinoid of GI tract, stage IV (C7A.019).
Who cannot join
- Does not have an active patient portal (MyPennMedicine) account,
- Does not use email at least once per month,
- Has already completed a living will,
- Does not speak fluent English,
- Unwilling to be contacted by email,
- Determined to be too ill or inappropriate for participation by patient's oncologist.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ruth & Raymond Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Comparison of a Web-based Advance Directive to a Standard Advance Directive: Randomized Evaluation
This study will compare a web-based advance directive to a standard advance directive.
Read the detailed description
Patients with GI and thoracic malignancies will be randomized to either a standard paper advance directive or the web advance directive (Ourcarewishes.org). Patients will be approached in the Cancer Center and provided the AD information to complete on their own. They will complete a survey at enrollment and a follow up survey administered by email. The primary endpoint will be proportion with new documentation in the EHR at 8 weeks. Second endpoints will include the change in satisfaction with end-of-life plans, AD acceptability, self-reported rates of completion, self-reported rate of sharing with their preferred surrogate decision-maker, proportion with new documentation of preferred decision-maker in the chart, and qualitative feedback. Patients in both groups will receive follow up reminder emails encouraging them to complete the advance directive.
- Conditions
- GI Cancer, Thoracic Cancer
- Being tested
- Web platform for advance care planning/advance directive, Standard advance directive
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web platform for advance care planning/advance directiveOther
Also called ourcarewishes.org
Ourcarewishes (OCW) is a web-based platform to document advance care planning based at Penn. OCW contains more detailed content on preferences and values than a standard advance directive and allows electronic sharing with loved ones and transmission to the Penn EHR.
Standard advance directiveOther
Patients receive a paper copy of an advance directive used by social workers at Penn Medicine and are encouraged to complete on their own.
| Study group | Role | What they receive |
|---|---|---|
| Web-based AD | Experimental | Patients will be encouraged to use the web platform for advance care planning/advance directive to document their care preferences.. Receives: Other: Web platform for advance care planning/advance directive |
| Paper AD | Active comparator | Patients will be given the standard advance directive and encouraged to complete on their own. Receives: Other: Standard advance directive |
What is being measured
The primary outcome is the main question the study is designed to answer.
New documentation of advance care planning in the EHR
any new advance directive or advance care planning note, excluding an advance directive that either 1) contains only information on the patient's preferred surrogate decision-makers, or 2) is blank except for personal identifying information.
Measured: 8 weeks
Secondary outcomes (6)
Change in satisfaction with end-of-life plans
Change in mean score on the satisfaction with end-of-life scale, adapted from doi: 10.1377/hlthaff.2012.0895, Canadian Healthcare Evaluation Project (CANHELP) questionnaire. This scale measures satisfaction with end-of-life planning on a 12-60 point scale (if all questions answered, 0 possible if "don't know/refusal" chosen for all 12 questions. Higher scores are considered better.
Measured: Initial completed at enrollment, survey sent again at 15 days
Acceptability
Mean score on an acceptability scale adapted from DOI: 10.1016/j.pec.2007.08.015. This is a scale that measures advance directive acceptability on a 5-50 point scale. Higher scores represent better outcomes.
Measured: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Self reporting sharing with surrogate
Proportion reporting sharing with preferred surrogate
Measured: Survey sent at 15 days (reminders 4, 6)Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Self reporting completion
Proportion reporting completing some or all of the advance directive
Measured: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Qualitative feedback
Comments on what patients liked, did not like, and would change about the advance directive
Measured: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Surrogate preferences
Proportion of subjects with new information about their preferred surrogate decision-maker in the chart
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start15 Oct 2018
- Primary completion20 Oct 2019
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GI CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676426
- Sponsor's protocol ID
- 829211
- Status last verified
- May 2020
- First submitted
- 7 Sep 2018
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Halpern SD, Loewenstein G, Volpp KG, Cooney E, Vranas K, Quill CM, McKenzie MS, Harhay MO, Gabler NB, Silva T, Arnold R, Angus DC, Bryce C. Default options in advance directives influence how patients set goals for end-of-life care. Health Aff (Millwood). 2013 Feb;32(2):408-17. doi: 10.1377/hlthaff.2012.0895.
PubMed 23381535Sudore RL, Landefeld CS, Barnes DE, Lindquist K, Williams BA, Brody R, Schillinger D. An advance directive redesigned to meet the literacy level of most adults: a randomized trial. Patient Educ Couns. 2007 Dec;69(1-3):165-95. doi: 10.1016/j.pec.2007.08.015. Epub 2007 Oct 17.
PubMed 17942272
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Web-based Advance Directive to a Standard Advance Directive: Randomized Evaluation
- ClinicalTrials.gov ID
- NCT03676426
- Acronym / sponsor ID
- 829211
- Conditions
- GI Cancer, Thoracic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 18 Sep 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.
This study will compare a web-based advance directive to a standard advance directive.
Detailed description
Patients with GI and thoracic malignancies will be randomized to either a standard paper advance directive or the web advance directive (Ourcarewishes.org). Patients will be approached in the Cancer Center and provided the AD information to complete on their own. They will complete a survey at enrollment and a follow up survey administered by email. The primary endpoint will be proportion with new documentation in the EHR at 8 weeks. Second endpoints will include the change in satisfaction with end-of-life plans, AD acceptability, self-reported rates of completion, self-reported rate of sharing with their preferred surrogate decision-maker, proportion with new documentation of preferred decision-maker in the chart, and qualitative feedback. Patients in both groups will receive follow up reminder emails encouraging them to complete the advance directive.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based AD | Experimental | Other: Web platform for advance care planning/advance directivePatients will be encouraged to use the web platform for advance care planning/advance directive to document their care preferences.. |
| Paper AD | Active comparator | Other: Standard advance directivePatients will be given the standard advance directive and encouraged to complete on their own. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Pancreatic cancer, any stage except stage 0 (C25),
- NSCLC, stage IIIA or higher (C34),
- SCLC, any stage (C34),
- Colon cancer, stage IIIB or greater (C18),
- Rectal cancer, stage IIB or greater (C21),
Key exclusion criteria (6 listed)
- Does not have an active patient portal (MyPennMedicine) account,
- Does not use email at least once per month,
- Has already completed a living will,
- Does not speak fluent English,
- Unwilling to be contacted by email,
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 |
|---|---|---|
| Web platform for advance care planning/advance directiveAlso: ourcarewishes.orgOurcarewishes (OCW) is a web-based platform to document advance care planning based at Penn. OCW contains more detailed content on preferences and values than a standard advance directive and allows electronic sharing with loved ones and transmission to the Penn EHR. | Other | Web-based AD |
| Standard advance directivePatients receive a paper copy of an advance directive used by social workers at Penn Medicine and are encouraged to complete on their own. | Other | Paper AD |
Primary outcome
New documentation of advance care planning in the EHR
Time frame: 8 weeks
any new advance directive or advance care planning note, excluding an advance directive that either 1) contains only information on the patient's preferred surrogate decision-makers, or 2) is blank except for personal identifying information.
6 secondary outcomes
Change in satisfaction with end-of-life plans
Time frame: Initial completed at enrollment, survey sent again at 15 days
Acceptability
Time frame: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Self reporting sharing with surrogate
Time frame: Survey sent at 15 days (reminders 4, 6)Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Self reporting completion
Time frame: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Qualitative feedback
Time frame: Survey sent at 15 days (reminders at 2 week intervals x 2, then phone call)
Surrogate preferences
Time frame: 8 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 7 May 2020.
- Background: PubMed 23381535Halpern SD, Loewenstein G, Volpp KG, Cooney E, Vranas K, Quill CM, McKenzie MS, Harhay MO, Gabler NB, Silva T, Arnold R, Angus DC, Bryce C. Default options in advance directives influence how patients set goals for end-of-life care. Health Aff (Millwood). 2013 Feb;32(2):408-17. doi: 10.1377/hlthaff.2012.0895.
- Background: PubMed 17942272Sudore RL, Landefeld CS, Barnes DE, Lindquist K, Williams BA, Brody R, Schillinger D. An advance directive redesigned to meet the literacy level of most adults: a randomized trial. Patient Educ Couns. 2007 Dec;69(1-3):165-95. doi: 10.1016/j.pec.2007.08.015. Epub 2007 Oct 17.
- Individual participant dataSharing planned: Undecided
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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 Web platform for advance care planning/advance directive and Standard advance directive in people with GI Cancer and Thoracic Cancer, run by University of Pennsylvania 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 11 inclusion and 6 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 7 May 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?
New documentation of advance care planning in the EHR (time frame: 8 weeks). 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 NCT03676426, which also lists 2 linked publications.
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 7 May 2020.