GEMS Program for Cancer Survivors

Recruiting at 11 trial locations

Overseen By Caitlyn Hoffman

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester NCORP Research Base

Disqualifiers: Surgery planned, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 4 weeks

960 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a program called GEMS (Comprehensive Geriatric Assessment) can enhance the physical and mental well-being of older cancer survivors after chemotherapy. GEMS provides personalized health advice, education, and exercise routines to determine if it is more effective than usual care. The trial seeks cancer survivors aged 65 or older who have completed chemotherapy for a solid tumor in the last six months, along with their caregivers. Participants will either continue with their usual care or join the GEMS program to compare outcomes. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve post-chemotherapy care for older adults.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the GEMS program is safe for cancer survivors?

Research has shown that the GEMS (Geriatric Evaluation and Management with Survivorship) program is generally safe for older adults who have survived cancer. GEMS includes a thorough health check-up and personalized health advice, such as daily walking and strength exercises. Studies have found that participants handle these activities well. No serious side effects directly related to GEMS have been reported. This suggests that the program is safe and may help improve physical abilities and overall well-being in older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GEMS Program for Cancer Survivors because it offers a more personalized approach to post-treatment care for older adults. Unlike standard care, which typically involves routine follow-up visits, the GEMS intervention includes a comprehensive geriatric assessment that tailors recommendations specifically for older cancer survivors. Additionally, the inclusion of the EXCAP program, which involves structured daily walking and resistance exercises, sets it apart by actively engaging patients in improving their physical health and quality of life. This holistic approach aims to address both the physical and educational needs of survivors, potentially leading to better long-term outcomes and a more empowered survivorship experience.

What evidence suggests that the GEMS program is effective for improving physical function in older cancer survivors?

Studies have shown that the Geriatric Evaluation and Management with Survivorship health education (GEMS), available to participants in this trial, can enhance the physical and mental health of older cancer survivors. Research indicates that this approach aids in daily tasks, reduces fatigue, and manages long-term treatment effects. Initial findings suggest that GEMS boosts physical abilities, memory, and overall quality of life. The program includes personalized assessments and education sessions, featuring exercises such as daily walking and resistance training. The goal is to improve the well-being of both cancer survivors and their caregivers. ^{1 2 6 7 8}

Who Is on the Research Team?

Supriya G Mohile

Principal Investigator

University of Rochester NCORP Research Base

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a caregiver who speaks and reads English or Spanish.

CANCER SURVIVORS: Be willing and able to provide informed consent and must sign consent in-person or remotely if it is not convenient or feasible to provide informed consent in-person

I am a caregiver chosen by a cancer survivor to help with their health matters.

Exclusion Criteria

I am a caregiver who understands the consent form and study procedures.

I am a cancer survivor with surgery planned within the next six months.

I am a caregiver with surgery planned within the next six months or have had surgery before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in Arm II receive GEMS consultation and survivorship health education sessions, including the EXCAP program, over 4 weeks

4 weeks

8 visits (in-person)

Follow-up

Participants in Arm I receive routine survivorship follow-up care for 5 visits over 12 months; caregivers are followed for 3 visits over 6 months

12 months

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Geriatric Assessment
• Educational Intervention
• Exercise Intervention
• Questionnaire Administration
• Tailored Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm II (GEMS intervention) Experimental Treatment 5 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 Control 2 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.

Who Is Running the Clinical Trial?

University of Rochester NCORP Research Base

Lead Sponsor

Trials

14

Recruited

9,100+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A survey of 69 Australian medical oncologists revealed that they recognize the importance of geriatric assessments (GA) in optimizing care for older cancer patients, particularly in addressing challenges like comorbidities and functional status.

While most oncologists see the value in incorporating GA and collaborating with geriatricians, they face barriers to access, emphasizing the need for timely reports to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilisation of geriatric assessment in oncology - a survey of Australian medical oncologists. To, THM., Soo, WK., Lane, H., et al.[2020]

A study involving 7556 older cancer patients showed that 67.9% had a geriatric risk profile, indicating a high level of vulnerability in this population.

An abnormal G8 geriatric screening score (≤14/17) was linked to significantly lower overall survival, with an adjusted hazard ratio of 1.62, highlighting the importance of geriatric assessments in predicting outcomes for older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking clinical and population-based data in older patients with cancer in Belgium: Feasibility and clinical outcomes. Depoorter, V., Vanschoenbeek, K., Decoster, L., et al.[2023]

A self-administered questionnaire designed for older cancer patients (aged 65 and older) effectively identified various health needs, including physical and psychological impairments, nutritional issues, and lack of social support, in a study involving 245 participants.

The questionnaire was well-received, with high acceptance rates regarding its length and content, suggesting it is a feasible tool for integrating geriatric assessments into cancer care, although further trials are needed to evaluate the effectiveness of the resulting interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying vulnerable older adults with cancer: integrating geriatric assessment into oncology practice. Hurria, A., Lichtman, SM., Gardes, J., et al.[2015]

A study involving 78 elderly cancer patients identified six key domains of geriatric assessment: general functioning, health-related quality of life, co-morbidities, social support, cognition, and nutritional status, explaining 77.1% of the variance in patient assessments.

Traditional assessment tools like WHO Performance Status and Karnofsky Index are effective for measuring physical functioning but do not adequately address other critical areas such as cognitive functioning and social support, highlighting the need for a more comprehensive approach in geriatric assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six independent domains are defined by geriatric assessment in elderly cancer patients. Stauder, R., Moser, K., Holzner, B., et al.[2019]

In a study of 85 cancer patients aged 65 and older, the G8 and Groningen Frailty Indicator (GFI) screening tools were not found to predict the risk of severe treatment toxicity after the first cycle of (radio)chemotherapy, despite being useful for selecting patients for Comprehensive Geriatric Assessment (CGA).

Out of the patients studied, 18% experienced serious adverse events (SAEs), including three fatalities, but there was no significant correlation between screening results and the occurrence of these SAEs, indicating that these tools may not effectively identify patients at higher risk for short-term treatment complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric screening results and the association with severe treatment toxicity after the first cycle of (radio)chemotherapy. Baitar, A., Van Fraeyenhove, F., Vandebroek, A., et al.[2016]

In a pilot study involving 15 early breast cancer patients aged 70 and older, a comprehensive geriatric assessment (CGA) every 3 months led to an 87% success rate in addressing various health problems, demonstrating its effectiveness in managing comorbidities.

The intervention resulted in improved quality of life, as indicated by an increase in mean Functional Assessment of Cancer Treatment-Breast (FACT-B) scores from 110.5 to 116.3, while also maintaining patients' function and independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive geriatric intervention detects multiple problems in older breast cancer patients. Extermann, M., Meyer, J., McGinnis, M., et al.[2019]

A geriatric assessment (GA) tool can be effectively implemented in community oncology clinics, with 339 out of 1088 patients assessed in these settings, demonstrating its feasibility for older adults receiving cancer treatment.

The time taken to complete the GA was comparable between academic and community clinics, suggesting that this assessment can be integrated into routine care without significant delays, although more patients in community settings required assistance with the questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of geriatric assessment in community oncology clinics. Williams, GR., Deal, AM., Jolly, TA., et al.[2016]

The increasing number of older adults requiring radiation therapy highlights the need for tailored treatment decisions, as many may not be suitable candidates for surgery or chemotherapy due to health complications.

Comprehensive Geriatric Assessment (CGA) and frailty screening tools are essential for identifying older patients who may benefit from CGA, aiding radiation oncologists in making informed treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recognizing Frailty in Radiation Oncology Clinical Practice: Current Evidence and Future Directions. Skelly, A., O'Donovan, A.[2022]

Integrating a patient-reported Geriatric Assessment (GA) in the management of older adults with gastrointestinal cancers is feasible, with 91.2% of eligible patients completing the assessment during their first clinic visit.

The assessment revealed significant impairments in this population, including high rates of dependence in daily activities (54.7%), falls (20.9%), and polypharmacy (74.0%), highlighting the need for tailored care in older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating geriatric assessment into routine gastrointestinal (GI) consultation: The Cancer and Aging Resilience Evaluation (CARE). Williams, GR., Kenzik, KM., Parman, M., et al.[2021]

In a study of 292 cancer patients aged 65 and older, a high prevalence of geriatric conditions was found, including instrumental ADL impairment (78%) and depressive symptoms (65%), indicating significant health challenges in this population.

Mortality rates were notably high, with 38% of patients dying within 3 months and 64% within 12 months, but mortality was primarily linked to cancer-related factors rather than geriatric conditions, suggesting that cancer severity may be a more critical determinant of outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of a comprehensive geriatric assessment for patient care in acutely hospitalized older patients with cancer. Hamaker, ME., Buurman, BM., van Munster, BC., et al.[2021]

The Comprehensive Geriatric Assessment (CGA) program at Metro North Hospital identified health issues in older cancer patients, with 59% of the 1380 patients screened showing impairments that warranted further assessment.

The most common issues found through CGA included mobility problems, malnutrition, polypharmacy, and low mood, indicating that tailored interventions can significantly support older patients undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Our experience of nursing/allied health practitioner led geriatric screening and assessment of older patients with cancer - a highly accessible model of care. Thaker, DA., McGuire, P., Bryant, G., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05006482

Study Details | NCT05006482 | Geriatric Evaluation and ... This phase III cluster randomized trial compares the effect of geriatric evaluation and management with survivorship health education (GEMS) to usual care

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35292232/

Protocol paper: Multi-site, cluster-randomized clinical trial for ... In this study, we will evaluate whether a Geriatric Evaluation and Management-Survivorship (GEMS) intervention improves functional outcomes ...

3. trialx.com trialx.com/clinical-trials/listings/279113/geriatric-evaluation-and-management-with-survivorship-health-education-gems-for-older-survivors-of-cancer/?&geo_lat=43.286&geo_lng=-77.6843&radius=10&place=Rochester&user_country=United%20States

Geriatric Evaluation and Management With Survivorship ... This phase III cluster randomized trial compares the effect of geriatric evaluation and management with survivorship health education (GEMS) to ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1879406822000479

Protocol paper: Multi-site, cluster-randomized clinical trial ... In this study, we will evaluate whether a Geriatric Evaluation and Management-Survivorship (GEMS) intervention improves functional outcomes important to older ...

5. urmc.rochester.edu urmc.rochester.edu/labs/geriatric-oncology/research-projects

Research Projects - Geriatric Oncology Lab GEM-S - Geriatric Evaluation and Management for Survivorship. This study will evaluate whether a standardized intervention-Geriatric Evaluation and Management ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9283231/

Protocol paper: Multi-site, cluster-randomized clinical trial for ... In this study, we will evaluate whether a Geriatric Evaluation and Management-Survivorship (GEMS) intervention improves functional outcomes important to older ...

7. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct05006482

Geriatric Evaluation and Management with Survivorship ... 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.

8. clinicaltrial.be clinicaltrial.be/en/details/191851?per_page=100&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Geriatric Evaluation and Management with Survivorship ... PRIMARY OBJECTIVE: I. To compare the efficacy of GEMS to usual care for improving patient-reported physical function (Functional Assessment ...