Clinical trial · Observational
Giving Information Systematically and Transparently in Lung and GI Cancer Phase 1
Giving Information Systematically and Transparently in Lung and GI Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Communication | — | UNRESOLVED | — |
| Critical Illness | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncolo-GIST | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Oncolo-GIST Arm: Caregivers
- description
- Caregiver stakeholders were bereaved family members of a patient who had died from solid tumor cancer in the past year. Stakeholders reviewed an initial version of the Oncolo-GIST manual to provide feedback and refine the manual for Phase 2.
- interventionNames
- Behavioral: Oncolo-GIST
- label
- Oncolo-GIST Arm: Clinicians
- description
- Clinician stakeholders were physicians, nurses, nurse practitioners, and social workers with expertise in treating advanced cancer patients. Stakeholders reviewed an initial version of the Oncolo-GIST manual to provide feedback and refine the manual for Phase 2.
- interventionNames
- Behavioral: Oncolo-GIST
Primary outcomes (4)
- measure
- Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Caregivers
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (45)
- BACKGROUNDLambden J, Zhang B, Friedlander R, Prigerson HG. Accuracy of Oncologists' Life-Expectancy Estimates Recalled by Their Advanced Cancer Patients: Correlates and Outcomes. J Palliat Med. 2016 Dec;19(12):1296-1303. doi: 10.1089/jpm.2016.0121. Epub 2016 Aug 30. PMID 27574869
- BACKGROUNDEnzinger AC, Zhang B, Schrag D, Prigerson HG. Outcomes of Prognostic Disclosure: Associations With Prognostic Understanding, Distress, and Relationship With Physician Among Patients With Advanced Cancer. J Clin Oncol. 2015 Nov 10;33(32):3809-16. doi: 10.1200/JCO.2015.61.9239. Epub 2015 Oct 5. PMID 26438121
- BACKGROUNDEpstein AS, Prigerson HG, O'Reilly EM, Maciejewski PK. Discussions of Life Expectancy and Changes in Illness Understanding in Patients With Advanced Cancer. J Clin Oncol. 2016 Jul 10;34(20):2398-403. doi: 10.1200/JCO.2015.63.6696. Epub 2016 May 23. PMID 27217454
- BACKGROUNDMack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol. 2010 Mar 1;28(7):1203-8. doi: 10.1200/JCO.2009.25.4672. Epub 2010 Feb 1. PMID 20124172
- BACKGROUNDWright AA, Zhang B, Keating NL, Weeks JC, Prigerson HG. Associations between palliative chemotherapy and adult cancer patients' end of life care and place of death: prospective cohort study. BMJ. 2014 Mar 4;348:g1219. doi: 10.1136/bmj.g1219. PMID 24594868
- BACKGROUNDPrigerson HG. Socialization to dying: social determinants of death acknowledgement and treatment among terminally ill geriatric patients. J Health Soc Behav. 1992 Dec;33(4):378-95. PMID 1464721
- BACKGROUNDWright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, Mitchell SL, Jackson VA, Block SD, Maciejewski PK, Prigerson HG. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008 Oct 8;300(14):1665-73. doi: 10.1001/jama.300.14.1665.