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Completed Not applicable Interventional Results available

Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2

ClinicalTrials.gov ID: NCT04179305

Public ClinicalTrials.gov record NCT04179305. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 12:31 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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. Medical oncologists (n=4) who care for these patients will also be consented for study participation and half (n=2) will be randomized to receive the Oncolo-GIST training. Patients will be assessed by trained research staff in the week prior to a scheduled meeting with their oncologist to discuss the scan results. This will provide patients' baseline levels of prognostic understanding and enable the investigator to determine how the intervention relates to pre-post scan visit changes in prognostic understanding. Patients will be assessed post-scan within a week of that progressive scan visit. The assessment battery that will be administered at these time-points will measure the patient's degree of prognostic understanding, the primary outcome of the study. Other outcomes that will be measured by the assessment battery include the patients quality of life, therapeutic alliances of the patient, whether or not a DNR was ordered, the care received by the patient, whether or not the patient preferred greater quality of longer quantity of life, and whether or not the patients received "value-consistent" care.

Study identification

NCT ID
NCT04179305
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
37 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 24, 2020
Primary completion
Jul 24, 2022
Completion
Jan 18, 2023
Last update posted
Apr 23, 2023

2020 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Weill Cornell Medical Center New York New York 10021

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04179305, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 23, 2023 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04179305 live on ClinicalTrials.gov.

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