GEMS Program for Cancer Survivors

Recruiting at 11 trial locations

Overseen by Supriya G Mohile

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Rochester NCORP Research Base

Disqualifiers: Surgery planned, Dementia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that GEMS Program for Cancer Survivors is an effective treatment?

The available research shows that the GEMS Program for Cancer Survivors, which includes comprehensive geriatric assessments, helps in creating personalized treatment plans for older cancer patients by identifying health issues that might affect their treatment. One study found that this approach improved the quality of life scores for breast cancer patients and maintained their independence. It also helped in addressing various health problems effectively, with an 87% success rate in solving these issues. This suggests that the GEMS Program is effective in optimizing care for older cancer patients. ^{1 2 3 4 5}

What safety data exists for the GEMS Program for Cancer Survivors?

The research indicates that geriatric assessments, which are part of the GEMS Program, are feasible and valuable in oncology settings, particularly for older adults with cancer. These assessments help determine the risk and benefits of cancer treatments and are associated with identifying severe treatment toxicity. However, specific safety data for the GEMS Program itself is not detailed in the provided research. ^{3 6 7 8 9}

Is the Comprehensive Geriatric Assessment a promising treatment for cancer survivors?

Yes, the Comprehensive Geriatric Assessment is a promising treatment for cancer survivors. It helps doctors understand the health needs of older cancer patients better, allowing them to make more informed decisions about their care. This assessment looks at various aspects of a patient's health, like their physical and mental abilities, nutrition, and social support, which can lead to better treatment outcomes. ^{1 3 6 10 11}

Research Team

Supriya G Mohile

Principal Investigator

University of Rochester NCORP Research Base

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Comprehensive Geriatric Assessment (Behavioural Intervention)
• Educational Intervention (Behavioural Intervention)
• Exercise Intervention (Behavioural Intervention)
• Questionnaire Administration (Behavioural Intervention)
• Tailored Intervention (Behavioural 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.

Participant Groups

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+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Utilisation of geriatric assessment in oncology - a survey of Australian medical oncologists. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A comprehensive geriatric intervention detects multiple problems in older breast cancer patients. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The value of a comprehensive geriatric assessment for patient care in acutely hospitalized older patients with cancer. [2021]

4. Netherlands 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Identifying vulnerable older adults with cancer: integrating geriatric assessment into oncology practice. [2015]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of geriatric assessment in community oncology clinics. [2016]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Integrating geriatric assessment into routine gastrointestinal (GI) consultation: The Cancer and Aging Resilience Evaluation (CARE). [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Geriatric screening results and the association with severe treatment toxicity after the first cycle of (radio)chemotherapy. [2016]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Linking clinical and population-based data in older patients with cancer in Belgium: Feasibility and clinical outcomes. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Recognizing Frailty in Radiation Oncology Clinical Practice: Current Evidence and Future Directions. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Six independent domains are defined by geriatric assessment in elderly cancer patients. [2019]