Clinical trial NCT04158908: Giving Information Systematically and Transparently in Lung and GI Cancer Phase 1
Official title: Giving Information Systematically and Transparently in Lung and GI Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Oncology
Communication
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-11-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers were selected from among families of past patients identified by clinicians at Weill Cornell Medicine. Clinicians with expertise in palliative medicine were selected from among colleagues of PI.

Brief 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.

Detailed description: Despite exciting recent advances in cancer treatments, there still, ultimately, comes a time when advanced disease progresses, and patients can reliably be expected to have months, not years, left to live. For patients with metastatic cancers studied in the investigator's Coping with Cancer NCI R01s, this comes after progression on 1st- or 2nd-line therapy -- be it chemo-, immune-, or targeted therapy. Prior studies conducted by the investigator have found that oncologists can reliably predict when patients have only months to live (e.g., remarkable agreement between oncologist estimates of months to live shared with patients and patients' actual survival of months). By contrast, patients appear largely unaware of their prognosis. For example, 5% of patients a median of 5 months from death, accurately understood they had incurable, late/end-stage, terminal cancer, and likely only months to live. Dying cancer patients appear to lack the prognostic understanding needed to make informed choices.

Patients who grasp that they are dying (e.g., the 8.6% who "get the gist" that they likely have months to live), relative to those who do not, have been shown to have: a) higher rates of advance care planning (ACP), b) receive less burdensome, unbeneficial care (e.g., fewer intensive care unit, ICU, stays, less cardiopulmonary resuscitation, CPR), and c) more value-consistent care. The investigator has found that patient prognostic understanding is improved by oncologist discussions of life-expectancy, but despite 71% of patients wanting to discuss prognosis with their oncologists (83% adult cancer patients thought prognostic information was extremely/very important), only 17.6% of cancer patients within months of death reported that they had discussed prognosis with their oncologist. Not only do oncologists appear to discuss prognosis less than patients want them to, but even when prognostic discussions do occur, the investigator has found that some approaches (e.g., matter-of-fact) are more effective than others (e.g., vague) for promoting patients' prognostic understanding. Thus, prior work identifies a need to improve communication to promote patient prognostic understanding in a way that oncologists will likely learn, accept, use, and possibly implement more broadly in clinical practice.

To address this need, the investigator developed the "Giving Information Simply \&Transparently" (GIST), Oncolo-GIST intervention -- a manualized oncologist communication intervention that simplifies how to impart prognostic information by focusing on 4 basic steps: 1) Giving scan information, 2) Informing prognosis, 3) Strategizing sensitively, and 4) Transparently asking what the patient heard. Unlike traditional emphasis on numerical or medical details, the Oncolo-GIST approach is based on Reyna's Fuzzy-Trace Theory of decision-making, which emphasizes the need for an understanding of the bottom-line gist of a situation. The Oncolo-GIST approach distills prognostic discussions to clear communication of end-of-life (EoL) decision-making essentials (e.g., life-expectancy). 3 specific aims of the Oncolo-GIST approach will be tested in 2 phases:

Phase 1 will consist of two parts: 1) An interview of key stakeholders/key informants regarding Oncolo-GIST Version 1.0 in order to inform refinements to produce Oncolo-GIST Version 2.0. 2) An open trial of Oncolo-GIST Version 1.0 to inform refinements to produce Oncolo-GIST Version 2.0.

Phase 2 will involve a cluster randomized trial of Oncolo-GIST Version 2.0 on 50 patients with metastatic cancers worse on at least 1 line of therapy (chemo-, immune-, targeted), whose oncologists do not expect to survive 12 months. Patients will be assessed in the week prior to their scheduled scan, within 1 week of the clinic visit in which progressive scan results are discussed, and then 2 and 4 months later to explore intervention effects on primary and secondary outcomes, respectively. Oncologists will be assessed in the week following that same clinic visit to obtain their impressions of the discussion of prognosis and the patient's prognostic understanding.

In the phase one stakeholder interviews the investigator aims to obtain feedback on Oncolo-GIST Version 1.0 from stakeholders/key informants on an early draft of the Oncolo-GIST manual and proposed approach 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 Delphi method involves gathering opinions from "experts" (i.e., key informants/stakeholders), keeping feedback anonymous, and circulating it back to experts until consensus is reached. Two feedback rounds will occur in Phase 1. The investigator will recruit 10 bereaved caregivers (e.g., family/friends such as widows) of patients who died in the past year with primary diagnoses of GI or lung cancers, and 10 oncology clinicians (oncologists, palliative care physicians, nurses, nurse practitioners, social workers and psychologists) who care for patients with metastatic GI and lung cancers to obtain their feedback on the Oncolo-GIST Version 1.0 manual and procedures. Consenting subjects will be provided a copy of the Oncolo-GIST 4-step manual and a survey to obtain structured feedback on content, format, and language, which they will be asked to return within 4-6 weeks. Responses will be reviewed and compiled and returned to experts for additional feedback on the revised manual. A 30-60-minute follow-up telephone or video-conferenced interview of experts will be conducted by study staff within the following 2 weeks to identify important themes that may be clinically useful to incorporate into the Oncolo-GIST 2.0 intervention. Interviews will be audio-recorded, transcribed, and kept confidential. The investigator has successfully employed these procedures in a prior study, the EMPOWER intervention, with cancer patient caregivers (CA218313).

In the phase 1 open trial the investigator aims to determine feasibility and acceptability of Oncolo-GIST Version 1.0 in a trial of 10 advanced cancer patients to gather information of the feasibility and acceptability of the intervention to patients and oncologists and to inform refinements that will result in Version 2.0.

We will consent the 8 available oncologists identified by Drs. Shah and Saxena in the GI and lung cancer clinics at Weill Cornell Medicine (WCM). The PI will assign a number to each of the 8 oncologists and provide these numbers to the study statistician who will then randomly assign 4 of the numbers to training in the Oncolo-GIST intervention and the other 4 to usual care. Ten patients who meet the eligibility criteria will receive care from 1 of the 4 oncologists trained in the intervention. Phase 1 expert data will be reviewed and summarized, indicating strengths and weaknesses of the intervention and recommended modifications. Phase 1 open trial data will be cleaned, collated, and analyzed. Feasibility of patient recruitment and retention and oncologists' ability to apply the technique will be evaluated. Acceptability will be assessed among oncologists randomized to the intervention and their patients. The quantitative and qualitative data will inform refinements to the study design and intervention procedures that will result in Oncolo-GIST Version 2.0. A summary document will identify the main thematic issues raised in gathering of the Phase 1 data and will explain how they will (or why they will not) be addressed in revisions to the intervention. The 4 oncologists trained in Version 1.0 will receive additional instruction to be compliant with Version 2.0.

The details for Phase 2 are enumerated in a separate record marked "Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2" (Oncolo-GIST P2), under NCT ID# NCT04179305.

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

Primary outcomes:
measure: Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Caregivers
timeFrame: From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.
measure: Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
timeFrame: From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.
measure: Feasibility of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
timeFrame: From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.
measure: Potential Improvements to the Oncolo-GIST Manual According to Structured Qualitative Surveys
timeFrame: From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Holly G Prigerson, PhD
role: PRINCIPAL_INVESTIGATOR
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