Patient-Centered Care for the Older Adult With Hematologic Malignancy

NCT ID: NCT02359838

Last Updated: 2022-07-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-01

Study Completion Date

2020-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hematologic Malignancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Usual Care

Frail/pre-frail hematologic oncology patients receive usual care

Group Type OTHER

Baseline Geriatric Screening/Assessment

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Baseline Geriatric Screening/Assessment

Intervention Type OTHER

All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.

Geriatrician Co-Management

Intervention Type OTHER

A board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm.

Interventions

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Baseline Geriatric Screening/Assessment

All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.

Intervention Type OTHER

Geriatrician Co-Management

A board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Gregory A. Abel, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory A. Abel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana Faber Cancer Institute

Jane A Driver, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://doi.org/10.3324/haematol.2021.278802

Randomized controlled trial of geriatric consultation versus standard care in older adults with hematologic malignancies

Other Identifiers

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14-515

Identifier Type: -

Identifier Source: org_study_id

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