NCT02359838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 19, 2022

Completed
Last Updated

July 19, 2022

Status Verified

March 1, 2022

Enrollment Period

3.2 years

First QC Date

February 2, 2015

Results QC Date

March 24, 2022

Last Update Submit

March 24, 2022

Conditions

Keywords

Hematologic MalignancyGeriatric AssessmentGeriatric OncologyFrailty

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Overall Survival at one year

    One year

Study Arms (2)

Usual Care

OTHER

Frail/pre-frail hematologic oncology patients receive usual care

Other: Baseline Geriatric Screening/Assessment

Geriatrician Co-Management

ACTIVE COMPARATOR

Frail/pre-frail hematologic oncology patients receive co-management by a geriatrician

Other: Baseline Geriatric Screening/AssessmentOther: Geriatrician Co-Management

Interventions

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

Geriatrician Co-ManagementUsual Care

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

Geriatrician Co-Management

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Links

MeSH Terms

Conditions

Hematologic NeoplasmsFrailty

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Results Point of Contact

Title
Gregory A. Abel
Organization
Dana-Farber Cancer Institute

Study Officials

  • Gregory A. Abel, MD, MPH

    Dana Faber Cancer Institute

    PRINCIPAL INVESTIGATOR
  • Jane A Driver, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 10, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2020

Last Updated

July 19, 2022

Results First Posted

July 19, 2022

Record last verified: 2022-03

Locations