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Giving Information Systematically and Transparently in Lung and GI Cancer Phase 1 (Oncolo-GIST Trial)

N/A
Waitlist Available
Led By Holly G Prigerson, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.
Awards & highlights
No Placebo-Only Group

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 the investigator's 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 first phase of this study will consists of two parts: 1. Stakeholder Interviews: The investigator will obtain feedback from relevant stakeholders/key informants on Oncolo-GIST Version 1.0 manual and videos using a version of the Delphi method in which the investigator will interview bereaved family caregivers of advanced cancer patients (n=10) and oncology clinicians who care for patients with advanced gastrointestinal (GI) and thoracic (lung) cancers (n=10). The information gathered will be used to develop Oncolo-GIST Version 2.0. 2. Open Trial: The investigator will conduct an initial open trial of the Oncolo-GIST intervention to 10 advanced cancer patients (N=10) by participant clinicians (n=8). This will help us gather information about the feasibility and acceptability of the intervention to patients and oncologists and also inform changes for Oncolo-GIST Version 2.0. This phase will be followed by second phased (listed in a separate record in ClinicalTrials.gov) that will include a randomized controlled trial of Oncolo-GIST Version 2.0. The record is titled "Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2" and its NCT ID# isNCT04179305.

Eligible Conditions
  • Critical Illness
  • Cancer
  • Communication

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Caregivers
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
Feasibility of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Oncolo-GIST Arm: CliniciansExperimental Treatment1 Intervention
Clinician stakeholders were physicians, nurses, nurse practitioners, and social workers with expertise in treating advanced cancer patients. Stakeholders reviewed an initial version of the Oncolo-GIST manual to provide feedback and refine the manual for Phase 2.
Group II: Oncolo-GIST Arm: CaregiversExperimental Treatment1 Intervention
Caregiver stakeholders were bereaved family members of a patient who had died from solid tumor cancer in the past year. Stakeholders reviewed an initial version of the Oncolo-GIST manual to provide feedback and refine the manual for Phase 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oncolo-GIST
2020
N/A
~60

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Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH
606 Previous Clinical Trials
10,378,696 Total Patients Enrolled
9 Trials studying Critical Illness
2,516 Patients Enrolled for Critical Illness
Weill Medical College of Cornell UniversityLead Sponsor
1,092 Previous Clinical Trials
1,154,766 Total Patients Enrolled
4 Trials studying Critical Illness
472 Patients Enrolled for Critical Illness
Holly G Prigerson, PhDPrincipal InvestigatorWeill Medical College of Cornell University
3 Previous Clinical Trials
46 Total Patients Enrolled
1 Trials studying Critical Illness
37 Patients Enrolled for Critical Illness
~3 spots leftby Jan 2026