GEMS Program for Cancer Survivors
Recruiting in Palo Alto (17 mi)
+11 other locations
Overseen BySupriya G Mohile
Age: 65+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Rochester NCORP Research Base
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.
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.
346710What 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.
456811Do 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.
12479Eligibility 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 cancer survivor and 65 years old or older.
Exclusion Criteria
I am a cancer survivor without conditions like dementia that prevent me from understanding or consenting to procedures.
Participant Groups
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.
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Southeast Clinical Oncology Research Consortium (SCOR)Winston-Salem, NC
Kaiser Permanente NCORP (KAISER)Vallejo, CA
Novant Health Cancer Institute - KernersvilleWinston-Salem, NC
Geisinger Cancer Institute NCORP (GEISINGER)Danville, PA
More Trial Locations
Loading ...
Who is running the clinical trial?
University of Rochester NCORP Research BaseLead Sponsor
National Cancer Institute (NCI)Collaborator
References
A comprehensive geriatric intervention detects multiple problems in older breast cancer patients. [2019]Studies of comprehensive geriatric assessment (CGA) have shown the importance of follow-up for effectiveness, but this has not been tested in an oncology clinic. In this pilot study, we enrolled 15 early breast cancer patients, aged 70 and older. They received a multidisciplinary CGA every 3 months and structured follow-up from the SAOP nurse practitioner, dietitian, social worker, and pharmacist according to risk. Total follow-up was 6 months. Median age of evaluable patients was 79 years (range 72-87). Median number of comorbidities by Cumulative Index Rating Scale-Geriatric (CIRS-G) was 5 (3-9) at baseline. Ten patients were at pharmacological risk, five at psychosocial risk, and eight at nutritional risk. Patients presented on average six problems initially, and three new problems during follow-up. The intervention directly influenced oncological treatment in four cases. It ensured continuity/coordination of care in seven cases. Success rate in addressing problems was 87%. Mean Functional Assessment of Cancer Treatment-Breast (FACT-B) scores improved from 110.5 (S.D. 16.7) to 116.3 (S.D. 16.5) (t=0.025). Function and independence were maintained.
Identifying vulnerable older adults with cancer: integrating geriatric assessment into oncology practice. [2015]To integrate the principles of geriatric assessment into the care of older patients with cancer in order to identify vulnerable older adults and develop interventions to optimize cancer treatment.
Six independent domains are defined by geriatric assessment in elderly cancer patients. [2019]Geriatric assessment (GA) must be integrated into treatment concepts for elderly cancer patients. Aim of this study was to assess the coverage of a large battery of GA instruments by determining the number of independent domains measured.
The value of a comprehensive geriatric assessment for patient care in acutely hospitalized older patients with cancer. [2021]A comprehensive geriatric assessment systematically collects information on geriatric conditions and is propagated in oncology as a useful tool when assessing older cancer patients.
Geriatric screening results and the association with severe treatment toxicity after the first cycle of (radio)chemotherapy. [2016]Screening tools are used in geriatric oncology to determine who should receive a Comprehensive Geriatric Assessment (CGA). However, in this prospective study, we evaluated the association between geriatric screening results, measured with the G8 and Groningen Frailty Indicator (GFI), and severe treatment toxicity.
Feasibility of geriatric assessment in community oncology clinics. [2016]Emerging results support the value of geriatric assessment (GA) in determining the risk and benefits of cancer treatment in older adults. A brief GA tool consisting of valid and reliable measures has been developed; however, little data exist on the ability to perform the GA in community oncology clinics. The objective of this study was to determine the feasibility of performing the GA in the community.
Utilisation of geriatric assessment in oncology - a survey of Australian medical oncologists. [2020]Geriatric assessment (GA) is a multidimensional health assessment of the older person to evaluate their physical and cognitive function, comorbidities, nutrition, medications, psychological state, and social supports. GA may help oncologists optimise care for older patients with cancer. The aim of this study was to explore the views of Australian medical oncologists regarding the incorporation of geriatric screening tools, GA and collaboration with geriatricians into routine clinical practice.
Integrating geriatric assessment into routine gastrointestinal (GI) consultation: The Cancer and Aging Resilience Evaluation (CARE). [2021]Integrating Geriatric Assessment (GA) in the management of older adults with cancer is recommended, yet rarely practiced in routine oncologic care. Our objective was to assess the feasibility of integrating routine GA in the management of older adults with gastrointestinal (GI) malignancies and characterize impairments in this population.
Our experience of nursing/allied health practitioner led geriatric screening and assessment of older patients with cancer - a highly accessible model of care. [2021]Comprehensive Geriatric Assessment (CGA) has been proven to assist development of tailored treatment plans for older patients with cancer by identifying health issues affecting their ability to complete systemic therapy or cope with and recover from cancer treatment.
Recognizing Frailty in Radiation Oncology Clinical Practice: Current Evidence and Future Directions. [2022]The number of older adults presenting for radiation therapy is increasing, as many older adults may be excluded from receipt of surgery and chemotherapy due to multimorbidity or concerns about toxicity. For radiation oncologists, making decisions about appropriate treatment modalities for their older patients can be difficult. Comprehensive Geriatric Assessment (CGA) is recommended to aid the decision-making process in radiation oncology, in conjunction with the judicious use of frailty screening tools, which are the first step in identifying those who need a CGA. In this review, the current scientific evidence regarding screening tools and CGA will be appraised in the context of radiation oncology. Several screening tools that have been tested in radiation oncology are described, as well as how they have been combined (or not) with CGA. Current clinical practice is reviewed, and future directions for radiation oncology are discussed.
Linking clinical and population-based data in older patients with cancer in Belgium: Feasibility and clinical outcomes. [2023]Geriatric screening and geriatric assessment (GS/GA) have proven their benefits in the care for older patients with cancer. However, less is known about the predictive value of GS/GA for outcomes. To research this, clinical data on GS/GA can be enriched with population-based data. In this article we describe the methods and feasibility of data linkage, and first clinical outcomes (GS/GA results and overall survival).