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GEMS Program for Cancer Survivors
N/A
Recruiting
Led By Supriya G Mohile
Research Sponsored by University of Rochester NCORP Research Base
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CANCER SURVIVORS: 65 years of age or older
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trialcompares GEMS (advice from doctor) to usual care to see if it helps older cancer survivors' physical, mental, and memory function.
Who is the study for?
This trial is for cancer survivors aged 65 or older who've finished chemotherapy within the last 4 weeks and may continue other treatments. They must be able to attend study visits or do them remotely, provide informed consent, and speak English/Spanish. Caregivers over 18 involved in their health matters can also join.Check my eligibility
What is being tested?
The GEMS program is being tested against usual care advice from doctors. It includes a comprehensive geriatric assessment, exercise routines, tailored interventions based on individual needs, best practices in survivorship care, educational materials about managing life post-cancer treatment, and regular questionnaires.See study design
What are the potential side effects?
Since this trial focuses on assessments and education rather than medication or invasive procedures, side effects are minimal but could include potential discomfort from increased physical activity during the exercise intervention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a cancer survivor and 65 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient-reported physical function as assessed by the Functional Assessment of Cancer Therapy Physical Well-Being Subscale (FACIT PWB) in cancer survivors.
Secondary outcome measures
Patient-reported cognitive function as assessed by Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog).
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (GEMS intervention)Experimental Treatment5 Interventions
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. They will participate in the EXCAP program as part of these sessions, which includes daily walking and resistance exercises.
Group II: Arm I (usual care)Active Control2 Interventions
Patients receive routine survivorship follow-up care at their doctor's office for 5 visits over 12 months. Caregivers will be followed for 3 visits over 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tailored Intervention
2015
N/A
~1780
Find a Location
Who is running the clinical trial?
University of Rochester NCORP Research BaseLead Sponsor
13 Previous Clinical Trials
8,183 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,925,481 Total Patients Enrolled
Supriya G MohilePrincipal InvestigatorUniversity of Rochester NCORP Research Base
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a caregiver who speaks and reads English or Spanish.I am a caregiver who understands the consent form and study procedures.I am a caregiver chosen by a cancer survivor to help with their health matters.I finished my cancer treatment aimed at curing it within the last 6 months.I am willing to attend study visits or do them remotely.I am a cancer survivor with surgery planned within the next six months.I am a cancer survivor and 65 years old or older.I am a caregiver and I am 18 years old or older.I am a caregiver with surgery planned within the next six months or have had surgery before.I am a cancer survivor without conditions like dementia that prevent me from understanding or consenting to procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (GEMS intervention)
- Group 2: Arm I (usual care)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for recruitment into this experiment presently?
"Affirmative. According to the information compiled on clinicaltrials.gov, this study was published on January 13th 2023 and updated most recently in February 8th of that same year. The research is actively recruiting 780 patients from 3 different sites."
Answered by AI
How many research subjects are enrolled in this experiment?
"In order to adequately proceed with this medical study, 780 eligible candidates are necessary. The trial is hosted in multiple locations including Metro Minnesota Community Oncology Research Consortium in Saint Louis Park, Minnesota and Wisconsin NCORP in Marshfield, Wisconsin."
Answered by AI
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