Geriatric assessment with management for older patients with cancer receiving radiotherapy: a cluster-randomised controlled pilot study.

BACKGROUND: Geriatric assessment and management (GAM) improve outcomes in older patients with cancer treated with surgery or chemotherapy. It is unclear whether GAM may provide better function and quality of life (QoL), or be cost-effective, in a radiotherapy (RT) setting. METHODS: In this Norwegian cluster-randomised controlled pilot study, we assessed the impact of a GAM intervention involving specialist and primary health services. It was initiated in-hospital at the start of RT by assessing somatic and mental health, function, and social situation, followed by individually adapted management plans and systematic follow-up in the municipalities until 8 weeks after the end of RT, managed by municipal nurses as patients' care coordinators. Thirty-two municipal/city districts were 1:1 randomised to intervention or conventional care. Patients with cancer ≥ 65 years, referred for RT, were enrolled irrespective of cancer type, treatment intent, and frailty status, and followed the allocation of their residential district. The primary outcome was physical function measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30). Secondary outcomes were overall quality of life (QoL), physical performance, use and costs of health services. Analyses followed the intention-to-treat principle. Study registration at ClinicalTrials.gov ID NCT03881137. RESULTS: We included 178 patients, 89 in each group with comparable age (mean 74.1), sex (female 38.2%), and Edmonton Frail Scale scores (mean 3.4 [scale 0-17], scores 0-3 [fit] in 57%). More intervention patients received curative RT (76.4 vs 61.8%), had higher irradiation doses (mean 54.1 vs 45.5 Gy), and longer lasting RT (mean 4.4 vs 3.6 weeks). The primary outcome was completed by 91% (intervention) vs 88% (control) of patients. No significant differences between groups on predefined outcomes were observed. GAM costs represented 3% of health service costs for the intervention group during the study period. CONCLUSIONS: In this heterogeneous cohort of older patients receiving RT, the majority was fit. We found no impact of the intervention on patient-centred outcomes or the cost of health services. Targeting a more homogeneous group of only pre-frail and frail patients is strongly recommended in future studies needed to clarify the role and organisation of GAM in RT settings.

Edmonton Frail Scale predicts mortality in older patients with cancer undergoing radiotherapy-A prospective observational study.

BACKGROUND: Several screening tools are developed to identify frailty in the increasing number of older patients with cancer. Edmonton Frail Scale (EFS) performs well in geriatric settings but is less studied in oncology. We aimed to investigate if EFS score (continuous and categorical) predicts survival in patients referred for radiotherapy, and to assess the concurrent validity of EFS compared with a modified geriatric assessment (mGA). METHODS: Prospective observational, single-center study including patients ≥65 years, referred for curative or palliative radiotherapy for confirmed cancer. Patients underwent mGA (assessment of cognition, mobility, falls, comorbidity, polypharmacy, depression, nutrition, and activities of daily living) and screening with EFS prior to radiotherapy. The predictive value of EFS score of two-year overall survival (OS) was assessed by Kaplan-Meier plots and compared by log-rank test. Cox proportional hazards regression model was estimated to adjust the associations for major cancer-related factors. Concurrent validity of EFS in relation to mGA was estimated by Spearman`s correlation coefficient and ordinal regression. Sensitivity and specificity for different cut-offs was assessed. RESULTS: Patients' (n = 301) mean age was 73.6 (SD 6.3) years, 159 (52.8%) were men, 54% received curative-intent treatment, breast cancer (32%) was the most prevalent diagnosis. According to EFS≥6, 101 (33.7%) were classified as frail. EFS score was predictive of OS [hazard ratio (HR) 1.20 (95% confidence interval (CI) 1.10-1.30)], as was increasing severity assessed by categorical EFS (p<0.001). There was a strong correlation between EFS score and number of geriatric impairments (Spearman`s correlation coefficient 0.77). EFS cut-off ≥6 had a sensitivity of 0.97 and specificity of 0.57 for identifying patients with minimum two geriatric impairments. CONCLUSION: EFS predicts mortality in older patients with cancer receiving radiotherapy, and it is a quick (<5 minutes) and sensitive screening tool to identify patients who may benefit from a geriatric assessment.

Geriatric impairments are associated with reduced quality of life and physical function in older patients with cancer receiving radiotherapy - A prospective observational study.

INTRODUCTION: Quality of life (QoL) and function are important outcomes for older adults with cancer. We aimed to assess differences in trends in patient-reported outcomes (PROs) during radiotherapy (RT) between (1) groups with curative or palliative treatment intent and (2) groups defined according to the number of geriatric impairments. MATERIALS AND METHODS: A prospective observational study including patients aged ≥65 years receiving curative or palliative RT was conducted. Geriatric assessment (GA) was performed before RT, and cut-offs for impairments within each domain were defined. Patients were grouped according to the number of geriatric impairments: 0, 1, 2, 3, and ≥ 4. Our primary outcomes, global QoL and physical function (PF), were assessed by The European Organisation for Research and Treatment of Cancer Quality-of-Life Core Questionnaire (EORTC) (QLQ-C30) at baseline, RT completion, and two, eight, and sixteen weeks later. Differences in trends in outcomes between the groups were assessed by linear mixed models. RESULTS: 301 patients were enrolled, mean age was 73.6 years, 53.8% received curative RT. Patients receiving palliative RT reported significantly worse global QoL and PF compared to the curative group. The prevalence of 0, 1, 2, 3 and ≥ 4 geriatric impairments was 16.6%, 22.7%, 16.9%, 16.3% and 27.5%, respectively. Global QoL and PF gradually decreased with an increasing number of impairments. These group differences remained stable from baseline throughout follow-up without any clinically significant changes for any of the outcomes. DISCUSSION: Increasing number of geriatric impairments had a profound negative impact on global QoL and PF, but no further decline was observed for any group or outcome, indicating that RT was mainly well tolerated. Thus, geriatric impairments per se should not be reasons for withholding RT. GA is key to identifying vulnerable patients in need of supportive measures, which may have the potential to improve treatment tolerance. Registered at clinicaltrials.gov (NCT03071640).

Cognitive Trajectories in Older Patients with Cancer Undergoing Radiotherapy-A Prospective Observational Study.

Cognitive function can be affected by cancer and/or its treatment, and older patients are at a particular risk. In a prospective observational study including patients ≥65 years referred for radiotherapy (RT), we aimed to investigate the association between patient- and cancer-related factors and cognitive function, as evaluated by the Montreal Cognitive Assessment (MoCA), and sought to identify groups with distinct MoCA trajectories. The MoCA was performed at baseline (T0), RT completion (T1), and 8 (T2) and 16 (T3) weeks later, with scores ranging between 0 and 30 and higher scores indicating better function. Linear regression and growth mixture models were estimated to assess associations and to identify groups with distinct MoCA trajectories, respectively. Among 298 patients with a mean age of 73.6 years (SD 6.3), the baseline mean MoCA score was 24.0 (SD 3.7). Compared to Norwegian norm data, 37.9% had cognitive impairment. Compromised cognition was independently associated with older age, lower education, and physical impairments. Four groups with distinct trajectories were identified: the very poor (6.4%), poor (8.1%), fair (37.9%), and good (47.7%) groups. The MoCA trajectories were mainly stable. We conclude that cognitive impairment was frequent but, for most patients, was not affected by RT. For older patients with cancer, and in particular for those with physical impairments, we recommend an assessment of cognitive function.

Geriatric impairments are prevalent and predictive of survival in older patients with cancer receiving radiotherapy: a prospective observational study.

BACKGROUND: A systematic assessment of problems that are frequent in older age (geriatric assessment [GA]) provides prognostic information for patients undergoing cancer surgery and systemic cancer treatment. We aimed to investigate the prevalence of geriatric impairments and their impact on survival in older patients with cancer receiving radiotherapy (RT). MATERIAL AND METHODS: A single-centre prospective observational study was conducted including patients ≥65 years referred for curative or palliative RT. Prior to RT, we performed a modified GA (mGA) assessing comorbidities, medications, nutritional status basic- and instrumental activities of daily living (IADL) mobility, falls, cognition and depressive symptoms. Impairments in each mGA domain were defined. Overall survival (OS) was presented by Kaplan Meier plots for groups defined according to the number of impairments, and compared by log-rank test. The association between mGA domains and OS was assessed by Cox proportional hazard regression analysis. RESULTS: Between February 2017 and July 2018, 301 patients were included, 142 (47.2%) were women. Mean age was 73.6 (SD 6.3) years, 162 (53.8%) received curative RT. During the median observation time of 24.2 months (min 0.3, max 25.9), 123 (40.9%) patients died. In the overall cohort, 49 (16.3%) patients had no geriatric impairment, 81 (26.9%) had four or more. OS significantly decreased with an increasing number of impairments (p < .01). Nutritional status (HR 0.90, 95% CI [0.81; 0.99], p = .038) and IADL function (HR 0.98, 95% CI [0.95; 1.00], p = .027) were independent predictors of OS. CONCLUSION: Geriatric impairments were frequent among older patients with cancer receiving RT and nutritional status and IADL function predicted OS. Targeted interventions to remediate modifiable impairments may have the potential to improve OS. TRIAL REGISTRATION: Cinicaltrials.gov ID:NCT03071640.

Geriatric assessment with management for older patients with cancer receiving radiotherapy. Protocol of a Norwegian cluster-randomised controlled pilot study.

About 50% of patients with cancer are expected to need radiotherapy (RT), and the majority of these are older. To improve outcomes for older patients with cancer, geriatric assessment (GA) with management (GAM) is highly recommended. Evidence for its benefits is still scarce, in particular for patients receiving RT. We report the protocol of a cluster-randomised pilot study designed to test the effect, feasibility and health economic impact of a GAM intervention for patients ≥65 years, referred for palliative or curative RT. The randomising units are municipalities and city districts. The intervention is municipality-based and carried out in collaboration between hospital and municipal health services from the start of RT to eight weeks after the end of RT. Its main constituents are an initial GA followed by measures adapted to individual patients' impairments and needs, systematic symptom assessments and regular follow-up by municipal cancer nurses, appointed to coordinate the patient's care. Follow-up includes at least one weekly phone call, and a house call four weeks after the end of RT. All patients receive an individually adapted physical exercise program and nutritional counselling. Detailed guidelines for management of patients' impairments are provided. Patients allocated to the intervention group will be compared to controls receiving standard care. The primary outcome is physical function assessed by the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire C-30. Secondary outcomes are global quality of life, objectively tested physical performance and use of health care services. Economic evaluation will be based on a comparison of costs and effects (measured by the main outcome measures). Feasibility will be assessed with mixed methodology, based on log notes and questionnaires filled in by the municipal nurses and interviews with patients and nurses. The study is carried out at two Norwegian RT centres. It was opened in May 2019. Follow-up will proceed until June 2022. Statistical analyses will start by the end of 2021. We expect the trial to provide important new knowledge about the effect, feasibility and costs of a GAM intervention for older patients receiving RT. Trial registration: ClinTrials.gov, ID NCT03881137, initial release 13th of March 2019.