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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Other | Frail/pre-frail hematologic oncology patients receive usual care |
|
| Geriatrician Co-Management | Active Comparator | Frail/pre-frail hematologic oncology patients receive co-management by a geriatrician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline Geriatric Screening/Assessment | Other | All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival at one year | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory A. Abel, MD, MPH | Dana Faber Cancer Institute | Principal Investigator |
| Jane A Driver, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
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| Label | URL |
|---|---|
| Randomized controlled trial of geriatric consultation versus standard care in older adults with hematologic malignancies | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Geriatrician Co-Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | Overall Survival at one year | Posted | Count of Participants | Participants | One year |
|
1 year
Adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory A. Abel | Dana-Farber Cancer Institute | 617-632-2304 | gregory_abel@dfci.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2020 | Mar 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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| Geriatrician Co-Management | Other | A board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm. |
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Frailty Status | Count of Participants | Participants |
|
|
|
| 21 |
| 100 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 11 | 60 | 0 | 0 | 0 | 0 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |