Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Change in Prognostic Understanding
Study Overview
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.
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 controlled trial (RCT) 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 them 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Change in Prognostic Understanding
Time Frame: Baseline; week after scan. 2- and - 4-month assessments were ultimately not done as participants preferred not to commit to follow-up.
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.
Secondary Outcomes
- 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.)