Trial Outcomes & Findings for Giving Information Systematically and Transparently in Lung and GI Cancer Phase 1 (NCT NCT04158908)
NCT ID: NCT04158908
Last Updated: 2023-04-21
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.
Results posted on
2023-04-21
Participant Flow
Participant milestones
| Measure |
Oncolo-GIST Arm: Caregivers
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.
|
Oncolo-GIST Arm: Clinicians
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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Giving Information Systematically and Transparently in Lung and GI Cancer Phase 1
Baseline characteristics by cohort
| Measure |
Oncolo-GIST Arm: Caregivers
n=11 Participants
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.
|
Oncolo-GIST Arm: Clinicians
n=9 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
High School
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
Some College
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
College
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
Postgraduate
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.Population: All caregivers who viewed and commented on the manual.
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.
Outcome measures
| Measure |
Oncolo-GIST Arm: Caregivers
n=10 Participants
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.
|
Oncolo-GIST Arm: Clinicians
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.
|
|---|---|---|
|
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Caregivers
Stakeholders found the intervention generally sensitive and empathetic.
|
9 Participants
|
—
|
|
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Caregivers
Phrases such as "months, not years" are clear and though difficult, important for patients to hear.
|
10 Participants
|
—
|
|
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Caregivers
"Prepare for the worst" may be overly harsh; noted and alternatives provided in new manual.
|
1 Participants
|
—
|
|
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Caregivers
Some participants found oncologist's delivery in videos "cold" and advised showing more empathy.
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.Population: All clinicians who viewed and commented on the manual
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.
Outcome measures
| Measure |
Oncolo-GIST Arm: Caregivers
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.
|
Oncolo-GIST Arm: Clinicians
n=8 Participants
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.
|
|---|---|---|
|
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
Generally very favorable reactions; respondents found intervention sensitive and empathetic.
|
—
|
8 Participants
|
|
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
Possible cultural insensitivity in asking how some patients feel after news; noted in manual.
|
—
|
1 Participants
|
|
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
Intervention may blur lines between physician and therapist; involve mental health professionals.
|
—
|
2 Participants
|
|
Acceptability of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
Some participants advised against breathing exercises in favor of therapeutic conversation.
|
—
|
3 Participants
|
PRIMARY outcome
Timeframe: From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.Population: All clinicians who viewed and remarked on the manual.
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.
Outcome measures
| Measure |
Oncolo-GIST Arm: Caregivers
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.
|
Oncolo-GIST Arm: Clinicians
n=8 Participants
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.
|
|---|---|---|
|
Feasibility of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
Clinicians broadly found the intervention helpful, feasible, and implementable in clinical setting.
|
—
|
8 Participants
|
|
Feasibility of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
Some clinicians noted physicians (especially if older) could be resistant to training in a new style
|
—
|
1 Participants
|
|
Feasibility of the Proposed Intervention According to a Structured Qualitative Survey of Clinicians
Clinicians noted that time constraints would make some therapeutic aspects of intervention difficult
|
—
|
2 Participants
|
PRIMARY outcome
Timeframe: From viewing the intervention to completing the survey, a period of approximately 2 hours occurring 1 week after enrollment.Population: All stakeholders who viewed and commented on the manual.
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.
Outcome measures
| Measure |
Oncolo-GIST Arm: Caregivers
n=10 Participants
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.
|
Oncolo-GIST Arm: Clinicians
n=8 Participants
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.
|
|---|---|---|
|
Potential Improvements to the Oncolo-GIST Manual According to Structured Qualitative Surveys
When training physicians, acceptability could be improved by framing O-Gist as a "time estimate"
|
0 Participants
|
1 Participants
|
|
Potential Improvements to the Oncolo-GIST Manual According to Structured Qualitative Surveys
The physician could give a brief overview of the disease course to orient the patient.
|
1 Participants
|
0 Participants
|
|
Potential Improvements to the Oncolo-GIST Manual According to Structured Qualitative Surveys
Some participants advised improving manual videos to emphasize compassion and personability.
|
3 Participants
|
1 Participants
|
|
Potential Improvements to the Oncolo-GIST Manual According to Structured Qualitative Surveys
Teach-back elements in manual should be revised to be sensitive and avoid "quizzing" patients.
|
1 Participants
|
1 Participants
|
Adverse Events
Oncolo-GIST Arm: Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oncolo-GIST Arm: Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place