Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02222259
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2014-08-18
Brief Title:
A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients A GEM Study for Older Cancer Patients
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the feasibility of implementing a randomized controlled study of the intervention Geriatric Assessment followed by an integrated care plan carried out by the multidisciplinary geriatric oncology team designed to maintainimprove quality of life and functional status in older adults with advanced gastrointestinal genitourinary or breast cancer referred for first line chemotherapy
Secondarily the study will investigate the impact of the Geriatric Assessment on the cancer treatment decision of the cancer specialist
Secondarily the study will investigate the impact of the Geriatric Assessment on the cancer treatment decision of the cancer specialist
Detailed Description:
Introduction A comprehensive geriatric assessment CGA can identify functional and psychosocial issues in older cancer patients which in turn can inform interventions to preventpostpone adverse outcomes and maintainimprove the functional status and well-being of this population However few randomized controlled trials RCTs have been completed showing the evidence
OBJECTIVE - To explore the feasibility and impact of a CGA followed by an integrated care plan on quality of life and functional status for older adults with advanced breast gastrointestinal or genitourinary cancer METHODS -
A two-group parallel single-blind phase II RCT is enrolling 60 patients aged 70 or above diagnosed with cancer and starting first line chemotherapy at Princess Margaret Cancer Centre in Toronto The randomization using sealed opaque envelopes is stratified by treatment intent adjuvant versus palliative The intervention entails a comprehensive CGA by a multidisciplinary geriatric oncology team followed by an integrated care plan to address any issues identified Participants in the intervention group are seen at baseline for the CGA and for initiation of the integrated care plan and again at 3 and 6 months to assess intervention fidelity and measure outcomes The co-primary outcomes are 1 maintainingimprovement in quality of life 2 refining of cancer treatment plan The secondary outcomes include 1 Functional status 2 feasibility of the study by tumor site
Recruitment has been completed November 2015
OBJECTIVE - To explore the feasibility and impact of a CGA followed by an integrated care plan on quality of life and functional status for older adults with advanced breast gastrointestinal or genitourinary cancer METHODS -
A two-group parallel single-blind phase II RCT is enrolling 60 patients aged 70 or above diagnosed with cancer and starting first line chemotherapy at Princess Margaret Cancer Centre in Toronto The randomization using sealed opaque envelopes is stratified by treatment intent adjuvant versus palliative The intervention entails a comprehensive CGA by a multidisciplinary geriatric oncology team followed by an integrated care plan to address any issues identified Participants in the intervention group are seen at baseline for the CGA and for initiation of the integrated care plan and again at 3 and 6 months to assess intervention fidelity and measure outcomes The co-primary outcomes are 1 maintainingimprovement in quality of life 2 refining of cancer treatment plan The secondary outcomes include 1 Functional status 2 feasibility of the study by tumor site
Recruitment has been completed November 2015
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None