Clinical trial · Interventional
Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2
- 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 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
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncolo-GIST | Behavioral | — | UNRESOLVED |
| Usual Care Arm | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Oncolo-GIST Arm - Patients
- description
- 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.
- interventionNames
- Behavioral: Oncolo-GIST
- type
- PLACEBO_COMPARATOR
- label
- Usual Care Arm - Patients
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Clinicians 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 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.