Protocol paper: Multi-site, cluster-randomized clinical trial for optimizing functional outcomes of older cancer survivors after chemotherapy.

BACKGROUND: Cancer survivors over the age of 65 have unique needs due to the higher prevalence of functional and cognitive impairment, comorbidities, geriatric syndromes, and greater need for social support after chemotherapy. In this study, we will evaluate whether a Geriatric Evaluation and Management-Survivorship (GEMS) intervention improves functional outcomes important to older cancer survivors following chemotherapy. METHODS: A cluster-randomized trial will be conducted in approximately 30 community oncology practices affiliated with the University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) Research Base. Participating sites will be randomized to the GEMS intervention, which includes Advanced Practice Practitioner (APP)-directed geriatric evaluation and management (GEM), and Survivorship Health Education (SHE) that is combined with Exercise for Cancer Patients (EXCAP©®), or usual care. Cancer survivors will be recruited from community oncology practices (of participating oncology physicians and APPs) after the enrolled clinicians have consented and completed a baseline survey. We will enroll 780 cancer survivors aged 65 years and older who have completed curative-intent chemotherapy for a solid tumor malignancy within four weeks of study enrollment. Cancer survivors will be asked to choose one caregiver to also participate for a total up to 780 caregivers. The primary aim is to compare the effectiveness of GEMS for improving patient-reported physical function at six months. The secondary aim is to compare effectiveness of GEMS for improving patient-reported cognitive function at six months. Tertiary aims include comparing the effectiveness of GEMS for improving: 1) Patient-reported physical function at twelve months; 2) objectively assessed physical function at six and twelve months; and 3) patient-reported cognitive function at twelve months and objectively assessed cognitive function at six and twelve months. Exploratory health care aims include: 1) Survivor satisfaction with care, 2) APP communication with primary care physicians (PCPs), 3) completion of referral appointments, and 4) hospitalizations at six and twelve months. Exploratory caregiver aims include: 1) Caregiver distress; 2) caregiver quality of life; 3) caregiver burden; and 4) satisfaction with patient care at six and twelve months. DISCUSSION: If successful, GEMS would be an option for a standardized APP-led survivorship care intervention. TRIAL REGISTRATION: ClinicalTrials.govNCT05006482, registered on August 9, 2021.

Expert consensus panel guidelines on geriatric assessment in oncology.

Despite consensus guidelines on best practice in the care of older patients with cancer, geriatric assessment (GA) has yet to be optimally integrated into the field of oncology in most countries. There is a relative lack of consensus in the published literature as to the best approach to take, and there is a degree of uncertainty as to how integration of geriatric medicine principles might optimally predict patient outcomes. The aim of the current study was to obtain consensus on GA in oncology to inform the implementation of a geriatric oncology programme. A four-round Delphi process was employed. The Delphi method is a structured group facilitation process, using multiple iterations to gain consensus on a given topic. Consensus was reached on the optimal assessment method and interventions required for the commonly employed domains of GA. Other aspects of GA, such as screening methods and age cut-off for assessment, represented a higher degree of disagreement. The expert panel employed in this study clearly identified the criteria that should be included in a clinical geriatric oncology programme. In the absence of evidence-based guidelines, this may prove useful in the care of older cancer patients.

Falls and functional impairments in cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study.

PURPOSE: This study was conducted in order to characterize the prevalence of falls and functional impairments (FIs) and their association with chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors. METHODS: We analyzed baseline assessments from a phase III RCT in cancer survivors with self-reported CIPN scores of >4 out of 10. Patients completed the EORTC QLQ-CIPN-20 for neuropathy and reported falls in the previous 3 months. FIs were defined using the Activities of Daily Living subsection of the Vulnerable Elder's Scale. Associations of baseline characteristics and CIPN with falls and FIs were examined using logistic regression. RESULTS: Of 421 patients, 11.9 % experienced recent falls and 26.6 % reported FIs. Motor neuropathy was the only factor associated with falls (OR = 1.127, p = 0.01). Factors associated with FIs included non-white race (OR = 0.335 white relative to non-white, 0.781, p = 0.01) and greater motor neuropathy scores (OR = 1.262, p < 0.0001). CONCLUSION: CIPN, primarily motor, is associated with falls and FIs. Future prospective research should investigate the ability of motor neuropathy severity to predict falls.