Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05006482
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2021-08-09
Brief Title:
Geriatric Evaluation and Management With Survivorship Health Education GEMS for Older Survivors of Cancer
Sponsor:
University of Rochester NCORP Research Base
Organization:
University of Rochester
Study Overview
Official Title:
Optimizing Functional Outcomes of Older Cancer Survivors After Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This phase III cluster randomized trial compares the effect of geriatric evaluation and management with survivorship health education GEMS to usual care on patient-reported physical function in older survivors of cancer Survivorship care for older adults of cancer usually consists of getting advice from their doctor This advice may include how to do their daily activities so they are less tired or how to manage multiple diseases or long-term side effects from treatment GEMS may help improve the physical ability to perform activities of daily living mental well-being and memory in older survivors of cancer after chemotherapy This study may help doctors learn if including GEMS in their practices improves physical mental and memory functions in their patients The study may also help to understand how such care affects cancer patients and their caregivers quality of life
Detailed Description:
PRIMARY OBJECTIVE
I To compare the efficacy of GEMS to usual care for improving patient-reported physical function Functional Assessment of Cancer Therapy-Fatigue Physical Well-Being Subscale FACIT-PWB in older cancer survivors at 6 months
SECONDARY OBJECTIVE
I To compare the efficacy of GEMS to usual care for improving patient-reported cognitive function FACT-cognitive function Cog in older cancer survivors at 6 months
OUTLINE Practice sites are randomized to 1 of 2 arms Participants are assigned to arms based on practice cluster
ARM I Patients receive routine survivorship follow-up care at their doctors office for 5 visits over 12 months Caregivers will be followed for 3 visits over 6 months
ARM II Patients and caregivers participate in GEMS consultation over 1 hour that includes discussion of results and recommendations from geriatric assessment Patients also participate in survivorship health education sessions over 75 minutes twice weekly for 4 weeks Patients also participate in Exercise for Cancer Patients EXCAP program which includes daily walking and resistance exercises
I To compare the efficacy of GEMS to usual care for improving patient-reported physical function Functional Assessment of Cancer Therapy-Fatigue Physical Well-Being Subscale FACIT-PWB in older cancer survivors at 6 months
SECONDARY OBJECTIVE
I To compare the efficacy of GEMS to usual care for improving patient-reported cognitive function FACT-cognitive function Cog in older cancer survivors at 6 months
OUTLINE Practice sites are randomized to 1 of 2 arms Participants are assigned to arms based on practice cluster
ARM I Patients receive routine survivorship follow-up care at their doctors office for 5 visits over 12 months Caregivers will be followed for 3 visits over 6 months
ARM II Patients and caregivers participate in GEMS consultation over 1 hour that includes discussion of results and recommendations from geriatric assessment Patients also participate in survivorship health education sessions over 75 minutes twice weekly for 4 weeks Patients also participate in Exercise for Cancer Patients EXCAP program which includes daily walking and resistance exercises
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-01760 | REGISTRY | None | None |
| URCC-19178 | OTHER | None | None |
| URCC-19178 | OTHER | None | None |
| URCC-19178 | OTHER | None | None |
| R01CA249467 | NIH | None | None |
| UG1CA189961 | NIH | CTEP | httpsreporternihgovquickSearchUG1CA189961 |