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NCT04179305 · ClinicalTrials.gov registry record · NA
Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2
A NA study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
NCT04179305: Completed NA study, sponsored by Weill Medical College of Cornell University.
NCT04179305 is a NA study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 37 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04179305, a NA study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
Study Summary
When advanced disease progresses, there comes a time when an oncologists must explain to their patients that they only have months left to live. During these discussions the oncologist attempts to explain to the patient their prognoses and what it means for them going forward. However our prior studies shown that even when patients only have months left to live, most do not understand that their cancer is incurable and that it is late/end-stage. Dying cancer patients who fully understand their prognosis are able to make more informed decisions and are therefore more likely to engage in advanced care planning, and receive care what in consistent with their values and preferences. They are also in a better position to avoid burdensome, non-beneficial care. The investigator developed Oncolo-GIST in order to help increase the number of patients who fully understand their prognosis and its implications. Oncolo-GIST is an intervention aimed at enhancing clinicians' communication with patients by teaching them to relay information both sensitively and using simple terminology. The Oncolo-GIST training will provide instruction in areas such as how to introduce the topic of prognosis (describe scan results as "worse"), how to phrase the prognosis itself ("likely months, not years"), how to explain expected treatment outcomes (e.g., "not expected to be cured by treatment") and how to describe expected treatments impact on quality of life - that is, whether the anticancer treatment is likely to make them feel overall better or worse. The training materials consist of a manual and a set of videos that act out situations described in the manual. The second phase of this study will be a randomized controlled trial. The investigator will recruit (n=50) adults with metastatic GI or lung cancers with scan results that reveal progression (worsened disease) on an initial systemic treatment; that is, patients whose life-expectancy can reliably be estimated to be months, not years. M
Primary Outcome
Changes in illness understanding by patients as measured by three items from the investigator's validated 4-item assessment will be compared between groups at baseline and post-scan follow-up. The assessment asks three questions that assess patients' recognition of their incurable disease status, knowledge of the advanced stage of their disease, and expectation to live months as opposed to years. Responses are coded 1 or 0 to indicate the presence or absence of each of these element. These four
Interventions
- BEHAVIORAL Oncolo-GIST
- BEHAVIORAL Usual Care Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-10-25 |
| Est. Completion | 2023-01-19 |
| Phase | NA |
What the finished NCT04179305 record still lists
NCT04179305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Oncolo-GIST is the first listed.
NCT04179305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04179305 about?
NCT04179305 is a clinical study titled "Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2". When advanced disease progresses, there comes a time when an oncologists must explain to their patients that they only have months left to live. During these discussions the oncologist attempts to explain to the patient their prognoses and what it means for them going forward. However our prior stud...
What is the current status of trial NCT04179305?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2020-10-25. Estimated completion is 2023-01-19.
What interventions are being tested in trial NCT04179305?
The interventions under investigation include: Oncolo-GIST (BEHAVIORAL), Usual Care Arm (BEHAVIORAL).
Who is sponsoring clinical trial NCT04179305?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04179305's enrollment target sits among peer trials
37 1540th of 2000 higher than 460 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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