Hematologic Malignancy
Conditions
Keywords
Hematologic Malignancy, Geriatric Assessment, Geriatric Oncology, Frailty
Brief summary
This research study is evaluating if co-management by a geriatrician embedded in the oncology clinic can improve outcomes for frail older adults with blood cancers. A rigorous pre-entry frailty assessment by a trained research assistant will be followed by randomization to geriatrician co-management versus usual care for patients found to be frail or pre-frail.
Detailed description
Older adults have unique health concerns, and in particular, older adults with blood cancers may have different disease and other health related issues than younger adults with similar diagnoses. One aspect of aging which can make older adults more vulnerable is frailty. Frailty is a general term that describes a decline in multiple areas of health, including the loss of energy, physical ability, and mental ability. Frailty can make it difficult for patients with cancer to respond to treatment and more likely to have side effects. On the other hand, many older patients are not frail despite advanced age. This study is being done to determine if co-management by a geriatrician of older adults who are found to be frail through a detailed baseline assessment can improve outcomes.
Interventions
OTHERBaseline Geriatric Screening/Assessment
All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.
OTHERGeriatrician Co-Management
A board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients aged 75 and older who present for an initial consultation at the Dana-Farber/Brigham and Women's Cancer Center for hematologic malignancy (transplantation consultation excluded). * Assessed to be pre-frail or frail on formal baseline geriatric assessment.
Exclusion criteria
* Not willing to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | One year | Overall Survival at one year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| 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. | 60 |
| Total | 160 |
Baseline characteristics
| Characteristic | Usual Care | Geriatrician Co-Management | Total |
|---|---|---|---|
| Age, Customized | 80.3 years STANDARD_DEVIATION 3.9 | 80.5 years STANDARD_DEVIATION 4.7 | 80.4 years STANDARD_DEVIATION 4.2 |
| Frailty Status Frail | 25 Participants | 11 Participants | 36 Participants |
| Frailty Status Pre-Frail | 75 Participants | 49 Participants | 124 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 36 Participants | 20 Participants | 56 Participants |
| Sex: Female, Male Male | 64 Participants | 40 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 21 / 100 | 11 / 60 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Overall Survival
Overall Survival at one year
Time frame: One year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Overall Survival | 79 Participants |
| Geriatrician Co-Management | Overall Survival | 49 Participants |