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N/A N=20

Giving Information Systematically and Transparently in Lung and GI Cancer Phase 1

Critical Illness · Oncology · Communication

Enrolled (actual)
20
Serious AEs
Results posted
Apr 2023
Primary outcome: Primary: Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Caregivers — 9; 10; 1; 3 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Oncolo-GIST (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Weill Medical College of Cornell University
Primary completion
Apr 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Caregivers
9; 10; 1; 3
PRIMARY
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
8; 1; 2; 3
PRIMARY
Feasibility of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
8; 1; 2
PRIMARY
Potential Improvements to the Oncolo-GIST Manual According to Structured Qualitative Surveys
3; 1; 1; 1; 0; 1

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.

Eligibility Criteria

Clinicians (Stakeholder Interviews)

Inclusion Criteria

  • Currently care for patients with metastatic GI and lung cancers as an oncologist, palliative care physician, nurse, nurse practitioner, social worker, or psychologist

Exclusion Criteria

  • Does not currently care for patients with metastatic GI and lung cancers as either an oncologist, palliative care physician, nurse, nurse practitioner, social worker, or psychologist

Caregivers (Stakeholder Interviews)

Inclusion Criteria

  • Caregivers of patients who died in the past year with a primary diagnoses of GI or lung cancer

Exclusion Criteria

  • Caregivers of patients who died longer than 1 year from the time of enrollment
  • Caregivers of a patient that did not have a primary diagnoses of GI or lung cancer
  • Not fluent in English

Clinicians (Open Trial)

Inclusion Criteria

  • Specialize in Lung and GI cancers
  • Currently provide care at the WCM Lung and GI cancer clinics
  • Fluent in English

Exclusion Criteria

  • Does not specialize in Lung and GI cancers
  • Does not currently provide care at the WCM Lung and GI cancer clinics
  • Not fluent in English

Patients (Open Trial)

Inclusion Criteria

  • Receiving ongoing care (≥ 2 visits) that includes regular scans
  • Progression on at least 1 line of systemic cancer therapy
  • Prognosis from an oncologist of less than 12 months
  • Receiving care from an oncologist participating in the Oncolo-GIST study
  • Fluent in English

Exclusion Criteria

  • Does not specialize in Lung and GI cancers
  • Does not currently provide care at the WCM Lung and GI cancer clinics
  • Not fluent in English
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04158908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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