Giving Information Systematically and Transparently in Lung and GI Cancer Phase 1 (Oncolo-GIST)
|ClinicalTrials.gov Identifier: NCT04158908|
Recruitment Status : Active, not recruiting
First Posted : November 12, 2019
Last Update Posted : June 23, 2020
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:
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness Oncology Communication||Behavioral: Oncolo-GIST||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Giving Information Systematically and Transparently in Lung and GI Cancer|
|Actual Study Start Date :||January 17, 2020|
|Estimated Primary Completion Date :||July 29, 2020|
|Estimated Study Completion Date :||July 29, 2020|
Experimental: Oncolo_GIST Arm
Patients in this arm will receive care from a clinician that received the Oncolo-GIST Version 1.0 intervention training.
Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in "gist communication" by itemizing 4 key steps in the process of imparting prognostic information.
Topic covered include:
The 4-step guide will include brief video-clips of demonstrating each "talking point" with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith.
- Acceptability of the proposed intervention according to a structured qualitative survey of caregivers [ Time Frame: 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.
- Acceptability of the proposed intervention according to a structured qualitative survey of clinicians [ Time Frame: 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.
- Feasibility of the proposed intervention according to a structured qualitative survey of clinicians [ Time Frame: 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.
- Potential improvements to the Oncolo-GIST manual according to structured qualitative surveys [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158908
|United States, New York|
|Weill Cornell Medical Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Holly G Prigerson, PhD||Weill Cornell Medicine|