Trial Outcomes & Findings for Patient-Centered Care for the Older Adult With Hematologic Malignancy (NCT NCT02359838)
NCT ID: NCT02359838
Last Updated: 2022-07-19
Results Overview
Overall Survival at one year
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
One year
Results posted on
2022-07-19
Participant Flow
Participant milestones
| Measure |
Usual Care
Frail/pre-frail hematologic oncology patients receive usual care
Baseline Geriatric Screening/Assessment: All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.
|
Geriatrician Co-Management
Frail/pre-frail hematologic oncology patients receive co-management by a geriatrician
Baseline Geriatric Screening/Assessment: All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.
Geriatrician Co-Management: A board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
60
|
|
Overall Study
COMPLETED
|
100
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Usual Care
n=100 Participants
Frail/pre-frail hematologic oncology patients receive usual care
Baseline Geriatric Screening/Assessment: All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.
|
Geriatrician Co-Management
n=60 Participants
Frail/pre-frail hematologic oncology patients receive co-management by a geriatrician
Baseline Geriatric Screening/Assessment: All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.
Geriatrician Co-Management: A board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
80.3 years
STANDARD_DEVIATION 3.9 • n=100 Participants
|
80.5 years
STANDARD_DEVIATION 4.7 • n=60 Participants
|
80.4 years
STANDARD_DEVIATION 4.2 • n=160 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=100 Participants
|
20 Participants
n=60 Participants
|
56 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=100 Participants
|
40 Participants
n=60 Participants
|
104 Participants
n=160 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Frailty Status
Pre-Frail
|
75 Participants
n=100 Participants
|
49 Participants
n=60 Participants
|
124 Participants
n=160 Participants
|
|
Frailty Status
Frail
|
25 Participants
n=100 Participants
|
11 Participants
n=60 Participants
|
36 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: One yearOverall Survival at one year
Outcome measures
| Measure |
Usual Care
n=100 Participants
Frail/pre-frail hematologic oncology patients receive usual care
Baseline Geriatric Screening/Assessment: All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.
|
Geriatrician Co-Management
n=60 Participants
Frail/pre-frail hematologic oncology patients receive co-management by a geriatrician
Baseline Geriatric Screening/Assessment: All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.
Geriatrician Co-Management: A board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm.
|
|---|---|---|
|
Overall Survival
|
79 Participants
|
49 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 21 deaths
Geriatrician Co-Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 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