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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

Must not have

CANCER SURVIVORS: Have a condition that precludes their ability to participate in informed consent or procedures (e.g., dementia and/or Blessed Orientation Memory Concentration [BOMC] Score >= 11)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

I am a cancer survivor and 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a cancer survivor without conditions like dementia that prevent me from understanding or consenting to procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-reported physical function as assessed by the Functional Assessment of Cancer Therapy Physical Well-Being Subscale (FACIT PWB) in cancer survivors.

Secondary study objectives

Patient-reported cognitive function as assessed by Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met