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.

Multivariate models for predicting abstention following intervention to stop smoking by general practitioners.

Predictors of successful smoking cessation were examined in a randomized controlled trial of 450 smokers who received an intervention by their general practitioner (GP). Pretreatment characteristics predicting outcome at 3, 6 and 12 months and for continuous abstinence to 12 months were determined using logistic regression analyses. Results showed the variables that significantly predicted abstention at 3 months were age and motivation, whereas the predictors at 6 months were socio-economic status, motivation, level of dependence and time spent with smokers. No single predictor emerged at 12 months. Predictors for continuous abstinence to 12 months were age, time spent with smokers and motivation. A model was developed which best describes the likelihood of patients achieving continuous long-term abstinence. The results show that five factors (high motivation level, older age, less time spent with smokers, low dependence level, and higher socio-economic status) together have a 76% accuracy of predicting continuous abstinence to 12 months.

One-year evaluation of three smoking cessation interventions administered by general practitioners.

Three smoking cessation interventions designed for use by general practitioners (GPs) within the routine consultation were evaluated in a field setting using 26 GPs throughout metropolitan Sydney. A total of 450 smoking patients were allocated to either Structured Behavioral Change with nicotine gum (Group SBCN), Structured Behavioral Change without nicotine gum (Group SBC), or GP advice with nicotine gum (Group AN). Although significant differences in the percentage of abstainers were observed between Groups SBCN and SBC three weeks after treatment (39% vs. 26%), the point prevalence abstinence rate for patients at 12 months declined to 19, 18, and 12% for Groups SBCN, SBC, and AN, respectively. Continuous abstinence to the end of the 12-month period was 9% for Groups SBCN and SBC, and 6% for Group AN. Forty-eight percent of the 450 patients made an attempt to stop smoking, and 89% reduced their cigarette consumption at some point during the study. Examination of 132 self-selecting patients who fully participated in the three interventions and attended all scheduled visits, revealed significantly larger proportions of abstainers within Groups SBCN (34%) and SBC (33%) than in Group AN (15%) at the 12-month follow-up.