NCT04179305: Oncolo-GIST

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

Completed NA Results posted Last updated 24 April 2023

What this trial tests

NA trial testing Oncolo-GIST in Critical Illness in 37 participants. Completed in 19 January 2023.

Timeline

25 October 2020

Primary endpoint
25 July 2022

19 January 2023

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	37
Start date	25 October 2020
Primary completion	25 July 2022
Estimated completion	19 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Oncolo-GIST
• Usual Care Arm

Conditions studied

• Critical Illness — all drugs for Critical Illness →
• Oncology — all drugs for Oncology →
• Communication — all drugs for Communication →

Sponsor

Weill Medical College of Cornell University

Who can join

18 and older, any sex, with Critical Illness or Oncology. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Prognostic Understanding Primary · 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

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0.58	± 1.00
Usual Care Arm - Patients	0.18	± 1.25

Whether or Not a Do Not Resuscitate Was Ordered by Patient Secondary · 1 week post-scan, 2 months post-scan, 4 months post-scan.

Whether or not a Do Not Resuscitate (DNR) was ordered by the patient, as determined by a medical chart abstraction, will be compared between groups at 2-month and 4-month follow up assessments (T4). This will be scored as either a 0, if there was no DNR ordered, or a 1 if there was a DNR ordered.

1 Week Post-Scan

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0
Usual Care Arm - Patients	0
Oncolo-GIST Arm - Physicians	0
Usual Care Arm - Physicians	0

2 months Post-Scan

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0
Usual Care Arm - Patients	0

Treatment and Care Received Secondary · 1 week post-scan, 2 months post-scan, 4 months post-scan.

Methods of treatment and care received by patients, as determined from a medical chart abstraction, will be compared between groups at 2-month and 4-month follow up assessments (T4). Types of care include palliative care, hospice and hospitalization. Types of treatment include chemotherapy drugs, narcotic pain medication and radiation therapy.

1 Week Post-Scan : Patients enrolled in hospice care

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0
Usual Care Arm - Patients	0

1 Week Post-Scan : Patients who had had a palliative care consult

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0
Usual Care Arm - Patients	0

1 Week Post-Scan: Patients who had been hospitalized within the past week.

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0
Usual Care Arm - Patients	1

1 Week Post-Scan: Patients who were receiving chemotherapy

Group	Value	95% CI
Oncolo-GIST Arm - Patients	10
Usual Care Arm - Patients	6

1 Week Post-Scan: Patients who were receiving radiation therapy

Group	Value	95% CI
Oncolo-GIST Arm - Patients	1
Usual Care Arm - Patients	1

1 Week Post-Scan: Patients who were receiving narcotic pain medication

Group	Value	95% CI
Oncolo-GIST Arm - Patients	7
Usual Care Arm - Patients	5

2 Months Post-Scan : Patients enrolled in hospice care

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0
Usual Care Arm - Patients	0

2 Months Post-Scan : Patients who had had a palliative care consult

Group	Value	95% CI
Oncolo-GIST Arm - Patients	1
Usual Care Arm - Patients	0

Change in Physician-Patient Therapeutic Alliance as Measured by the Human Connection Scale Secondary · Baseline, week after scan.

Changes in 11-item Human Connection Scale (Mack et al., 2009) total score and individual item scores after scan discussion. Total scores have a range of 0-44 and are calculated by summing individual item scores from the 11 items on the assessment. Individual items are scored from 0-4. In both cases, higher scores mean a better outcome: a stronger physician-patient therapeutic alliance. Change scores are calculated by subtracting the mean at the week after scan (T1) from the mean at baseline. A positive change indicates a better outcome (strengthening of the therapeutic alliance), whereas a neg

Change in Human Connection Scale total score

Group	Value	95% CI
Oncolo-GIST Arm - Patients	-1.00	± 1.63
Usual Care Arm - Patients	0.14	± 1.57

Change in individual item: Likes oncologist

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0.00	± 0.00
Usual Care Arm - Patients	0.00	± 0.00

Change in individual item: trusts oncologist

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0.00	± 0.00
Usual Care Arm - Patients	0.00	± 0.00

Change in individual item: Oncologist is concerned about your quality of life.

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0.23	± 0.44
Usual Care Arm - Patients	0.27	± 1.01

Change in individual item: doctor asks how you are coping with cancer.

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0.15	± 0.80
Usual Care Arm - Patients	0.09	± 1.14

Change in individual item: Doctor asks how family members are coping with illness.

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0.50	± 1.27
Usual Care Arm - Patients	0.20	± 0.63

Change in individual item: Feels comfortable asking doctor questions.

Group	Value	95% CI
Oncolo-GIST Arm - Patients	-0.42	± 0.90
Usual Care Arm - Patients	0.00	± 0.00

Change in individual item: Oncologist takes the time to listen to concerns.

Group	Value	95% CI
Oncolo-GIST Arm - Patients	-0.08	± 0.64
Usual Care Arm - Patients	0.00	± 0.45

Change in Anxiety and Depression as Measured by the Hospital Anxiety and Depression Scale Anxiety and Depression Subscores Secondary · Baseline, week after scan

Changes in Hospital Anxiety and Depression Scale Anxiety and Depression subscores, each with a minimum of 0 and maximum of 21, with a higher score meaning a worse outcome and a negative change between timepoints indicating improvement.

Anxiety subscore change

Group	Value	95% CI
Oncolo-GIST Arm - Patients	0.64	± 2.50
Usual Care Arm - Patients	0.40	± 1.43

Depression subscore change

Group	Value	95% CI
Oncolo-GIST Arm - Patients	1.64	± 3.80
Usual Care Arm - Patients	2.45	± 3.14

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Giving information strategically and transparently: A pilot trial of the Oncolo-GIST intervention to promote patients' prognostic understanding.
   Prigerson HG, Russell D, Kakarala SE, Derry-Vick HM, et al · · 2023 · cited 2× · PMID 37551156 · DOI 10.1002/cam4.6420