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Giving Information Systematically and Transparently in Lung and GI Cancer Phase 1 (Oncolo-GIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158908
Recruitment Status : Active, not recruiting
First Posted : November 12, 2019
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.


Condition or disease Intervention/treatment Phase
Critical Illness Oncology Communication Behavioral: Oncolo-GIST Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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

Arm Intervention/treatment
Experimental: Oncolo_GIST Arm
Patients in this arm will receive care from a clinician that received the Oncolo-GIST Version 1.0 intervention training.
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.

Topic covered include:

  1. Principles of introducing prognosis in the setting of worsened scan results
  2. 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")
  3. Addressing informational needs and psychological reactions
  4. 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.





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158908


Locations
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United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Holly G Prigerson, PhD Weill Cornell Medicine
Additional Information:
Publications:
de Meyrick J: The Delphi Method and Health Research. Health Education 103:7-16, 2003
Morse JM: Designing funded qualitative research. Handbook of qualitative research, Denzin and Lincoln (eds), Thousand Oaks, CA, Sage Publications, Inc:220-235, 1994

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04158908    
Other Study ID Numbers: 19-07020392-Phase1
R21NR018693-01 ( U.S. NIH Grant/Contract )
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes