NCT04158908: Oncolo-GIST

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

Completed Results posted Last updated 21 April 2023

What this trial tests

trial testing Oncolo-GIST in Critical Illness in 20 participants. Completed in 29 July 2020.

Timeline

17 January 2020

Primary endpoint
16 April 2020

29 July 2020

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	20
Start date	17 January 2020
Primary completion	16 April 2020
Estimated completion	29 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Oncolo-GIST

Conditions studied

• Critical Illness — all drugs for Critical Illness →
• Oncology — all drugs for Oncology →
• Communication — all drugs for Communication →

Sponsor

Weill Medical College of Cornell University

Who can join

18 and older, any sex, with Critical Illness or Oncology. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Caregivers Primary · From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.

Acceptability will be determined by requesting and comparing caregivers' responses to the specific phrasings indicated in the Oncolo-GIST manual for oncologists, with regard to sensitivity and comprehensibility.

Stakeholders found the intervention generally sensitive and empathetic.

Group	Value	95% CI
Oncolo-GIST Arm: Caregivers	9

Phrases such as "months, not years" are clear and though difficult, important for patients to hear.

Group	Value	95% CI
Oncolo-GIST Arm: Caregivers	10

"Prepare for the worst" may be overly harsh; noted and alternatives provided in new manual.

Group	Value	95% CI
Oncolo-GIST Arm: Caregivers	1

Some participants found oncologist's delivery in videos "cold" and advised showing more empathy.

Group	Value	95% CI
Oncolo-GIST Arm: Caregivers	3

Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians Primary · From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.

Acceptability will be determined by requesting and comparing a range of clinicians' responses to the specific phrasings indicated in the Oncolo-GIST manual, with regard to sensitivity, comprehensibility, and accordance with the principles of informed consent.

Generally very favorable reactions; respondents found intervention sensitive and empathetic.

Group	Value	95% CI
Oncolo-GIST Arm: Clinicians	8

Possible cultural insensitivity in asking how some patients feel after news; noted in manual.

Group	Value	95% CI
Oncolo-GIST Arm: Clinicians	1

Intervention may blur lines between physician and therapist; involve mental health professionals.

Group	Value	95% CI
Oncolo-GIST Arm: Clinicians	2

Some participants advised against breathing exercises in favor of therapeutic conversation.

Group	Value	95% CI
Oncolo-GIST Arm: Clinicians	3

Feasibility of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians Primary · From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.

Feasibility will be determined by requesting and comparing clinicians' responses to the manual's format and content, to determine the extent to which it is implementable in a clinical setting.

Clinicians broadly found the intervention helpful, feasible, and implementable in clinical setting.

Group	Value	95% CI
Oncolo-GIST Arm: Clinicians	8

Some clinicians noted physicians (especially if older) could be resistant to training in a new style

Group	Value	95% CI
Oncolo-GIST Arm: Clinicians	1

Clinicians noted that time constraints would make some therapeutic aspects of intervention difficult

Group	Value	95% CI
Oncolo-GIST Arm: Clinicians	2

Potential Improvements to the Oncolo-GIST Manual According to Structured Qualitative Surveys Primary · From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.

Using a version of the Delphi method 14, the responses of caregivers and clinicians will be anonymously amalgamated and compared in order to identify common criticisms of or suggestions for the manual, by frequency or priority, which can be implemented in Oncolo-GIST 2.0.

Some participants advised improving manual videos to emphasize compassion and personability.

Group	Value	95% CI
Oncolo-GIST Arm: Caregivers	3
Oncolo-GIST Arm: Clinicians	1

Teach-back elements in manual should be revised to be sensitive and avoid "quizzing" patients.

Group	Value	95% CI
Oncolo-GIST Arm: Caregivers	1
Oncolo-GIST Arm: Clinicians	1

When training physicians, acceptability could be improved by framing O-Gist as a "time estimate"

Group	Value	95% CI
Oncolo-GIST Arm: Caregivers	0
Oncolo-GIST Arm: Clinicians	1

The physician could give a brief overview of the disease course to orient the patient.

Group	Value	95% CI
Oncolo-GIST Arm: Caregivers	1
Oncolo-GIST Arm: Clinicians	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.