Trial Outcomes & Findings for Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer (NCT NCT02054741)
NCT ID: NCT02054741
Last Updated: 2024-04-12
Results Overview
Proportion of patients who experienced grade 3-5 toxicity within 3 months of initiation of new treatment regimen. Toxicity was graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
733 participants
Primary outcome timeframe
3 months
Results posted on
2024-04-12
Participant Flow
823 patients were screened. 66 failed screening and 24 withdrew before starting the intervention
Unit of analysis: Practice Clusters
Participant milestones
| Measure |
Arm I (GA Intervention)
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
Overall Study
STARTED
|
362 16
|
371 24
|
|
Overall Study
COMPLETED
|
210 16
|
242 24
|
|
Overall Study
NOT COMPLETED
|
152 0
|
129 0
|
Reasons for withdrawal
| Measure |
Arm I (GA Intervention)
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
13
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
5
|
|
Overall Study
Death
|
94
|
90
|
|
Overall Study
Subject passively continued participation only with data obtained from their medical records
|
35
|
32
|
Baseline Characteristics
2 patients did not report age, 1 from each arm.
Baseline characteristics by cohort
| Measure |
Arm I (GA Intervention)
n=349 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
n=369 Participants
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
Total
n=718 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.2 years
STANDARD_DEVIATION 5.7 • n=348 Participants • 2 patients did not report age, 1 from each arm.
|
77.2 years
STANDARD_DEVIATION 5.2 • n=368 Participants • 2 patients did not report age, 1 from each arm.
|
77.2 years
STANDARD_DEVIATION 5.4 • n=716 Participants • 2 patients did not report age, 1 from each arm.
|
|
Age, Customized
Patient categorical age · 70-79 years old
|
244 Participants
n=348 Participants • 2 patients did not report age, 1 from each arm.
|
250 Participants
n=368 Participants • 2 patients did not report age, 1 from each arm.
|
494 Participants
n=716 Participants • 2 patients did not report age, 1 from each arm.
|
|
Age, Customized
Patient categorical age · 80-89 years old
|
94 Participants
n=348 Participants • 2 patients did not report age, 1 from each arm.
|
110 Participants
n=368 Participants • 2 patients did not report age, 1 from each arm.
|
204 Participants
n=716 Participants • 2 patients did not report age, 1 from each arm.
|
|
Age, Customized
Patient categorical age · 90+ years old
|
10 Participants
n=348 Participants • 2 patients did not report age, 1 from each arm.
|
8 Participants
n=368 Participants • 2 patients did not report age, 1 from each arm.
|
18 Participants
n=716 Participants • 2 patients did not report age, 1 from each arm.
|
|
Sex: Female, Male
Female
|
145 Participants
n=348 Participants • 2 patients did not report sex, 1 from each arm.
|
166 Participants
n=368 Participants • 2 patients did not report sex, 1 from each arm.
|
311 Participants
n=716 Participants • 2 patients did not report sex, 1 from each arm.
|
|
Sex: Female, Male
Male
|
203 Participants
n=348 Participants • 2 patients did not report sex, 1 from each arm.
|
202 Participants
n=368 Participants • 2 patients did not report sex, 1 from each arm.
|
405 Participants
n=716 Participants • 2 patients did not report sex, 1 from each arm.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=349 Participants
|
1 Participants
n=369 Participants
|
6 Participants
n=718 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
341 Participants
n=349 Participants
|
365 Participants
n=369 Participants
|
706 Participants
n=718 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=349 Participants
|
3 Participants
n=369 Participants
|
6 Participants
n=718 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=349 Participants
|
4 Participants
n=369 Participants
|
7 Participants
n=718 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=349 Participants
|
1 Participants
n=369 Participants
|
13 Participants
n=718 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=349 Participants
|
0 Participants
n=369 Participants
|
4 Participants
n=718 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=349 Participants
|
12 Participants
n=369 Participants
|
52 Participants
n=718 Participants
|
|
Race (NIH/OMB)
White
|
285 Participants
n=349 Participants
|
350 Participants
n=369 Participants
|
635 Participants
n=718 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=349 Participants
|
1 Participants
n=369 Participants
|
4 Participants
n=718 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=349 Participants
|
1 Participants
n=369 Participants
|
3 Participants
n=718 Participants
|
|
Race/Ethnicity, Customized
Study-reported Race/Ethnicity · Non-Hispanic White
|
281 Participants
n=349 Participants
|
347 Participants
n=369 Participants
|
628 Participants
n=718 Participants
|
|
Race/Ethnicity, Customized
Study-reported Race/Ethnicity · Black
|
40 Participants
n=349 Participants
|
12 Participants
n=369 Participants
|
52 Participants
n=718 Participants
|
|
Race/Ethnicity, Customized
Study-reported Race/Ethnicity · Other
|
26 Participants
n=349 Participants
|
9 Participants
n=369 Participants
|
35 Participants
n=718 Participants
|
|
Race/Ethnicity, Customized
Study-reported Race/Ethnicity · Unknown or Not Reported
|
2 Participants
n=349 Participants
|
1 Participants
n=369 Participants
|
3 Participants
n=718 Participants
|
|
Region of Enrollment
United States
|
349 participants
n=349 Participants
|
369 participants
n=369 Participants
|
718 participants
n=718 Participants
|
|
Marital Status
Single or Never Married
|
11 Participants
n=349 Participants
|
6 Participants
n=369 Participants
|
17 Participants
n=718 Participants
|
|
Marital Status
Married or Domestic Partnership
|
212 Participants
n=349 Participants
|
237 Participants
n=369 Participants
|
449 Participants
n=718 Participants
|
|
Marital Status
Separated, Widowed, or Divorced
|
125 Participants
n=349 Participants
|
125 Participants
n=369 Participants
|
250 Participants
n=718 Participants
|
|
Marital Status
Unknown or Not Reported
|
1 Participants
n=349 Participants
|
1 Participants
n=369 Participants
|
2 Participants
n=718 Participants
|
|
Education
Less than high school
|
58 Participants
n=349 Participants
|
53 Participants
n=369 Participants
|
111 Participants
n=718 Participants
|
|
Education
High school graduate
|
119 Participants
n=349 Participants
|
125 Participants
n=369 Participants
|
244 Participants
n=718 Participants
|
|
Education
Some college or above
|
171 Participants
n=349 Participants
|
190 Participants
n=369 Participants
|
361 Participants
n=718 Participants
|
|
Education
Unknown or Not Reported
|
1 Participants
n=349 Participants
|
1 Participants
n=369 Participants
|
2 Participants
n=718 Participants
|
|
Income
Less than or equal to $50,000
|
189 Participants
n=349 Participants
|
182 Participants
n=369 Participants
|
371 Participants
n=718 Participants
|
|
Income
More than $50,000
|
94 Participants
n=349 Participants
|
96 Participants
n=369 Participants
|
190 Participants
n=718 Participants
|
|
Income
Declined to answer
|
65 Participants
n=349 Participants
|
90 Participants
n=369 Participants
|
155 Participants
n=718 Participants
|
|
Income
Unknown or Not Reported
|
1 Participants
n=349 Participants
|
1 Participants
n=369 Participants
|
2 Participants
n=718 Participants
|
|
Cancer Type
Breast
|
19 Participants
n=349 Participants
|
37 Participants
n=369 Participants
|
56 Participants
n=718 Participants
|
|
Cancer Type
Gastrointestinal
|
132 Participants
n=349 Participants
|
115 Participants
n=369 Participants
|
247 Participants
n=718 Participants
|
|
Cancer Type
Genitourinary
|
56 Participants
n=349 Participants
|
53 Participants
n=369 Participants
|
109 Participants
n=718 Participants
|
|
Cancer Type
Gynaecological
|
29 Participants
n=349 Participants
|
14 Participants
n=369 Participants
|
43 Participants
n=718 Participants
|
|
Cancer Type
Lung
|
64 Participants
n=349 Participants
|
116 Participants
n=369 Participants
|
180 Participants
n=718 Participants
|
|
Cancer Type
Lymphoma
|
23 Participants
n=349 Participants
|
23 Participants
n=369 Participants
|
46 Participants
n=718 Participants
|
|
Cancer Type
Other
|
26 Participants
n=349 Participants
|
11 Participants
n=369 Participants
|
37 Participants
n=718 Participants
|
|
Cancer Stage
Stage III
|
42 Participants
n=349 Participants
|
35 Participants
n=369 Participants
|
77 Participants
n=718 Participants
|
|
Cancer Stage
Stage IV
|
304 Participants
n=349 Participants
|
324 Participants
n=369 Participants
|
628 Participants
n=718 Participants
|
|
Cancer Stage
Other
|
3 Participants
n=349 Participants
|
10 Participants
n=369 Participants
|
13 Participants
n=718 Participants
|
|
Previous Chemo
Yes
|
104 Participants
n=349 Participants
|
81 Participants
n=369 Participants
|
185 Participants
n=718 Participants
|
|
Previous Chemo
No
|
234 Participants
n=349 Participants
|
277 Participants
n=369 Participants
|
511 Participants
n=718 Participants
|
|
Previous Chemo
Unknown or Not Reported
|
11 Participants
n=349 Participants
|
11 Participants
n=369 Participants
|
22 Participants
n=718 Participants
|
|
Treatment Type
Single agent chemotherapy
|
79 Participants
n=349 Participants
|
68 Participants
n=369 Participants
|
147 Participants
n=718 Participants
|
|
Treatment Type
Multiple agent chemotherapy
|
141 Participants
n=349 Participants
|
194 Participants
n=369 Participants
|
335 Participants
n=718 Participants
|
|
Treatment Type
Chemotherapy and other agents
|
85 Participants
n=349 Participants
|
66 Participants
n=369 Participants
|
151 Participants
n=718 Participants
|
|
Treatment Type
Non-chemotherapy
|
44 Participants
n=349 Participants
|
41 Participants
n=369 Participants
|
85 Participants
n=718 Participants
|
|
Number GA
|
4.6 Impairments
STANDARD_DEVIATION 1.6 • n=349 Participants
|
4.4 Impairments
STANDARD_DEVIATION 1.5 • n=369 Participants
|
4.5 Impairments
STANDARD_DEVIATION 1.6 • n=718 Participants
|
|
Number of Practice Sites
|
16 practice sites
n=349 Participants
|
24 practice sites
n=369 Participants
|
40 practice sites
n=718 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All patients who had data collected at baseline were included in this analysis.
Proportion of patients who experienced grade 3-5 toxicity within 3 months of initiation of new treatment regimen. Toxicity was graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0.
Outcome measures
| Measure |
Arm I (GA Intervention)
n=349 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
n=369 Participants
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
Patient Experienced Any Grade 3-5 Toxicity
|
0.51 proportion of participants
|
0.71 proportion of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All patients who had data collected at baseline were included in this analysis.
Proportion of patients who were alive at 6 months (183 days) after enrollment estimated by Kaplan-Meier method.
Outcome measures
| Measure |
Arm I (GA Intervention)
n=349 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
n=369 Participants
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
Patient Survival at 6 Months
|
0.71 proportion of participants
|
0.74 proportion of participants
|
SECONDARY outcome
Timeframe: 4-6 weeksPopulation: All patients who had data collected at baseline were included in this analysis.
Proportion of patients with reduced dose intensity in cycle 1.
Outcome measures
| Measure |
Arm I (GA Intervention)
n=349 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
n=369 Participants
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
Reduced Dose Intensity
|
0.49 proportion of participants
|
0.35 proportion of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled patients in Arm 1: GA Intervention with Impaired Physical Performance
The type and frequency of GA-driven recommendations implemented for older patients with impaired physical performance and starting a new treatment regimen for advanced cancer. Physical Performance measures included: Timed Up and Go, Short Physical Performance Battery, Falls History, and OARS Physical Health.
Outcome measures
| Measure |
Arm I (GA Intervention)
n=314 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Refer to: physical therapist (outpatient or home-based depending on eligibility for home care)
|
74 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Refer to: occupational therapist
|
35 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Refer to: aide services
|
45 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Refer to: personal emergency response information
|
62 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Refer to: vision specialist if difficulties
|
38 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Physical Examination: check orthostatic blood pressure
|
92 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Physical Examination: decrease/eliminate blood pressure meds if blood pressure is low or low normal
|
67 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Medication Review: minimize psychoactive meds including those used for supportive care
|
115 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Medication Review: minimize duplicative medications
|
150 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Treatment modification: consider single agent rather than doublet therapy if appropriate
|
105 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Treatment modification: modify dosage
|
147 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Treatment modification: modify treatment regimen
|
155 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Treatment modification: conduct frequent toxicity check (weekly or every other week)
|
270 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Treatment modification: choose non-neurotoxic regimen for treatment over a neurotoxic regimen
|
116 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Inform: provide fall counselling handout
|
270 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Inform: provide energy conservation handout
|
259 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
Inform: exercise or exercise prescription
|
262 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled patients in Arm 1: GA Intervention with Impaired Functional Status
The type and frequency of GA-driven recommendations implemented for older patients with impaired functional status and starting a new treatment regimen for advanced cancer. Functional Status measures included: Activities of Daily Living and Instrumental Activities of Daily Living.
Outcome measures
| Measure |
Arm I (GA Intervention)
n=200 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Refer to: occupational therapist
|
26 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Refer to: aide services
|
32 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Refer to: personal emergency response information
|
45 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Refer to: home nursing services
|
25 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Physical Examination: check orthostatic blood pressure
|
56 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Physical Examination: decrease/eliminate blood pressure meds if blood pressure is low or low normal
|
40 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Medication Review: minimize psychoactive meds including those used for supportive care
|
74 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Medication Review: minimize duplicative medications
|
103 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Treatment modification: consider single agent rather than doublet therapy if appropriate
|
72 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Treatment modification: modify dosage
|
98 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Treatment modification: modify treatment regimen
|
106 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Treatment modification: conduct frequent toxicity check
|
173 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Inform: provide fall counselling handout
|
170 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Inform: provide energy conservation handout
|
162 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
Inform: exercise or exercise prescription
|
169 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled patients in Arm 1: GA Intervention with Impaired Comorbidities
The type and frequency of GA-driven recommendations implemented for older patients with impaired comorbidities and starting a new treatment regimen for advanced cancer. Comorbidity measure included: OARS Comorbidity.
Outcome measures
| Measure |
Arm I (GA Intervention)
n=236 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
GA-driven Recommendations Made Among Patients With Impaired Comorbidities.
Initiate direct communication with patient's primary care physician about the cancer treatment plan
|
201 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Comorbidities.
Modify treatment choices: diabetes history- avoid neurotoxic agents if another option is equivalent
|
45 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Comorbidities.
Modify treatment choices: heart failure history - minimize volume/infusion rate of agents
|
28 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Comorbidities.
Modify treatment choices: renal impairment history - adjust as appropriate
|
45 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Comorbidities.
Modify treatment choices: Modify dosage/schedule if concern about tolerance/worsening comorbidities
|
113 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Comorbidities.
Provide smoking cessation counseling if the patient currently smokes
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled patients in Arm 1: GA Intervention with Impaired Cognition
The type and frequency of GA-driven recommendations implemented for older patients with impaired cognition and starting a new treatment regimen for advanced cancer. Cognition measures included: Blessed Orientation Memory Concentration and Mini Cog assessments.
Outcome measures
| Measure |
Arm I (GA Intervention)
n=140 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Treatment modification: modify treatment choice
|
42 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Assess decision-making capacity and if lacking elicit health care proxy information and input
|
88 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Refer to: clinician experienced in memory care
|
10 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Refer to: social work
|
43 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Refer to: palliative care
|
22 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Nueropsychological testing if dementia is suspected
|
6 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
TSH if dementia is suspected
|
12 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
B12 if dementia is suspected
|
12 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Brain imaging
|
16 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Provide information on cognitive rehabilitation or memory care programs
|
30 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Give patient/family member handout on delirium risk
|
32 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Provide explicit and written instructions for appointments, medications, and treatment
|
104 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Pillbox: confirm that someone else will help fill
|
62 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Pillbox: separate by am, noon, pm, and night
|
53 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Medication review: minimize psychoactive and high risk medications
|
89 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Treatment modification: modify dosage
|
68 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Cognition.
Treatment modification: modify treatment regimen
|
61 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled patients in Arm 1: GA Intervention with Impaired Nutrition
The type and frequency of GA-driven recommendations implemented for older patients with impaired nutrition and starting a new treatment regimen for advanced cancer. Nutrition measures included: Body Mass Index, Weight Loss, and Mini Nutrition Assessment.
Outcome measures
| Measure |
Arm I (GA Intervention)
n=211 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
Refer to: speech and swallow if difficulty with swallowing
|
10 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
Inform: nutrition handout
|
169 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
Treatment modification: utilize aggressive anti-emetic therapy
|
153 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
Refer to: nutritionist/clinical dietician
|
93 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
Refer to: meals-on-wheels
|
13 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
Refer to: dentist if poor dentition or denture issues
|
20 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
Treatment modification: use caution with highly emetogenic regimens and use another if appropriate
|
135 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
Treatment modification: conduct frequent toxicity check
|
192 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
Inform: mucositis handout
|
133 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
Recommend saline-peroxide mouthwash if treatment has high risk of mucositis
|
88 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled patients in Arm 1: GA Intervention with Impaired Social Support
The type and frequency of GA-driven recommendations implemented for older patients with impaired social support and starting a new treatment regimen for advanced cancer. Social Support measure included: OARS Medical Social Support.
Outcome measures
| Measure |
Arm I (GA Intervention)
n=111 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Refer or inform: community resource mobilization
|
28 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Confirm documented health care proxy is in medical record
|
78 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Modify treatment choice and/or dosage
|
67 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Refer or inform: ride assistance program
|
22 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Refer or inform: social worker via on-site or visiting nurse services
|
51 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Refer of inform: social worker via online services
|
0 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Refer or inform: visiting nurse service or home health aide (if meets criteria)
|
17 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Refer or inform: alternative living environments
|
0 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Refer or inform: assistance programs
|
0 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Refer or inform: medical insurance advising, advocacy, and negotiation
|
19 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Social Support.
Refer or inform: legal assistance for economic and social needs
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled patients in Arm 1: GA Intervention with Impaired Polypharmacy
The type and frequency of GA-driven recommendations implemented for older patients with impaired polypharmacy and starting a new treatment regimen for advanced cancer. Polypharmacy measure included: medication review.
Outcome measures
| Measure |
Arm I (GA Intervention)
n=287 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
Ask patient to bring in prescribed, OTC medications, and supplements to review at the next visit
|
158 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
Contact primary care provider to help reduce regimen complexity
|
82 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
Reduce medicines solely used for hypertension or diabetes if appropriate
|
59 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
Consult the pharmacist to synchronize medication refills
|
52 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
Have pharmacist meet with the patient to evaluate drug interactions and medication counseling
|
59 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
Provide written instructions for taking new medications
|
184 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
Recommend pillbox and/or medication calendar
|
123 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
Provide handout on polypharmacy
|
223 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled patients in Arm 1: GA Intervention with Impaired Psychological Status
The type and frequency of GA-driven recommendations implemented for older patients with impaired psychological status and starting a new treatment regimen for advanced cancer. Psychological measures included: Geriatric Depression Scale and Generalized Anxiety Disorder - 7 item scale.
Outcome measures
| Measure |
Arm I (GA Intervention)
n=107 Participants
Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
|
Arm II (Usual Care)
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
|
|---|---|---|
|
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
Provide written or verbal communication with primary care physician
|
44 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
Refer to: counseling or psychotherapy
|
20 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
Refer to: social work
|
42 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
Refer to: spiritual counseling or Chaplaincy services
|
18 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
Refer to: psychiatry if severe symptoms or if already on medications which are not adequate
|
11 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
Refer to: palliative care if other physical and/or cancer symptoms are present
|
24 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
Initiate pharmacologic therapy if appropriate in conjunction with primary care provider
|
18 Participants
|
—
|
|
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
Provide linkage to community resources
|
30 Participants
|
—
|
Adverse Events
Arm I (GA Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 99 deaths
Arm II (Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 94 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Supriya Mohile, Professor of Medicine
University of Rochester, Medical Center
Phone: 585-275-0394
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place