Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2

NCT04179305 | Completed Results DMC

• 2 other identifiers: 19-07020392-Phase2R21NR018693
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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 our 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 second phase of this study will be a randomized controlled trial. The investigator will recruit (n=50) adults with metastatic GI or lung cancers with scan results that reveal progression (worsened disease) on an initial systemic treatment; that is, patients whose life-expectancy can reliably be estimated to be months, not years. Medical oncologists (n=4) who care for these patients will also be consented for study participation and half (n=2) will be randomized to receive the Oncolo-GIST training. Patients will be assessed by trained research staff in the week prior to a scheduled meeting with their oncologist to discuss the scan results. This will provide patients' baseline levels of prognostic understanding and enable the investigator to determine how the intervention relates to pre-post scan visit changes in prognostic understanding. Patients will be assessed post-scan within a week of that progressive scan visit. The assessment battery that will be administered at these time-points will measure the patient's degree of prognostic understanding, the primary outcome of the study. Other outcomes that will be measured by the assessment battery include the patients quality of life, therapeutic alliances of the patient, whether or not a DNR was ordered, the care received by the patient, whether or not the patient preferred greater quality of longer quantity of life, and whether or not the patients received "value-consistent" care.

Conditions

Critical Illness; Oncology; Communication

Outcome Measures

Primary Outcomes (1)

• Change in Prognostic Understanding

  Changes in illness understanding by patients as measured by three items from the investigator's validated 4-item assessment will be compared between groups at baseline and post-scan follow-up. The assessment asks three questions that assess patients' recognition of their incurable disease status, knowledge of the advanced stage of their disease, and expectation to live months as opposed to years. Responses are coded 1 or 0 to indicate the presence or absence of each of these element. These four indicators are then added together to construct summary scores (possible range, 0 to 3). Differences between pre- and post-scan visit illness understanding scores (possible range, -3 to 3) are used to define changes in illness understanding by a patient between the pre- and post-scan visit interviews. Higher total scores represent an increase in prognostic understanding. Lower scores represent a decrease in understanding.

  Baseline; week after scan. 2- and - 4-month assessments were ultimately not done as participants preferred not to commit to follow-up.

Secondary Outcomes (4)

• Patient Quality of Life

  Day 1, within one week, 2 months, 4 month

• Whether or Not a Do Not Resuscitate Was Ordered by Patient

  1 week post-scan, 2 months post-scan, 4 months post-scan.

• Treatment and Care Received

  1 week post-scan, 2 months post-scan, 4 months post-scan.

• Patient Performance Status

  1 week post-scan, 2 months post-scan.

Study Arms (4)

Oncolo-GIST Arm - Patients

EXPERIMENTAL

Patients assigned to this arm will discuss scan results revealing progressive disease with an Oncolo-GIST trained physician. Oncolo-GIST: Behavioral: Oncolo-GIST 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. Topics covered include: Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis.

Behavioral: Oncolo-GIST

Usual Care Arm - Patients

PLACEBO COMPARATOR

Patients assigned to this arm will will discuss scan results revealing progressive disease with a physician that was not trained with the Oncolo-GIST intervention. Usual Care Arm: Oncologists will provide care in non-specific manner.

Behavioral: Usual Care Arm

Oncolo-GIST Arm - Physicians

EXPERIMENTAL

Physicians assigned to this arm will receive the Oncolo-GIST training intervention.

Behavioral: Oncolo-GIST

Usual Care Arm - Physicians

PLACEBO COMPARATOR

Physicians assigned to this arm will not receive the Oncolo-GIST training intervention.

Behavioral: Usual Care Arm

Interventions

Oncolo-GIST BEHAVIORAL

Behavioral: Oncolo-GIST 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. Topics covered include: Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis. 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.

Oncolo-GIST Arm - Patients; Oncolo-GIST Arm - Physicians

Usual Care Arm BEHAVIORAL

Oncologists will provide care in non-specific manner.

Usual Care Arm - Patients; Usual Care Arm - Physicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Related Publications (45)

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MeSH Terms

Conditions

Critical Illness; Neoplasms; Communication

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

Enrollment was lower than planned, limiting statistical power and generalizability of the results. Due to technical error, some measures, including the McGill Quality of Life scale and a question about terminal illness understanding from the patient assessments, were omitted. We also modified the protocol to eliminate two planned follow-ups to increase acceptability. Therefore, we did not analyze most planned secondary outcomes.

Results Point of Contact

• Title: Sophia Kakarala
• Organization: Weill Cornell Medicine

sok4004@med.cornell.edu

(646) 962-5650

Study Officials

• Holly G Prigerson, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized controlled trial

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: October 25, 2020
• Primary Completion: July 25, 2022
• Study Completion: January 19, 2023
• Last Updated: April 24, 2023
• Results First Posted: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)