Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer.

PURPOSE: Providing a geriatric assessment (GA) summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients with advanced cancer receiving treatment. This secondary analysis of a national cluster randomized clinical trial (ClinicalTrials.gov identifier: NCT02054741) aims to assess the effects of a GA intervention on symptomatic toxicity measured by Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). METHODS: From 2014 to 2019, the study enrolled patients age ≥ 70 years, with advanced solid tumors or lymphoma and ≥ 1 GA domain impairment, who were initiating a regimen with high prevalence of toxicity. Patients completed PRO-CTCAEs, including the severity of 24 symptoms (11 classified as core symptoms) at enrollment, 4-6 weeks, 3 months, and 6 months. Symptoms were scored as grade ≥ 2 (at least moderate) and grade ≥ 3 (severe/very severe). Symptomatic toxicity was determined by an increase in severity during treatment. A generalized estimating equation model was used to assess the effects of the GA intervention on symptomatic toxicity. RESULTS: Mean age was 77 years (range, 70-96 years), 43% were female, and 88% were White, 59% had GI or lung cancers, and 27% received prior chemotherapy. In 706 patients who provided PRO-CTCAEs at baseline, 86.1% reported at least one moderate symptom and 49.7% reported severe/very severe symptoms at regimen initiation. In 623 patients with follow-up PRO-CTCAE data, compared with usual care, fewer patients in the GA intervention arm reported grade ≥ 2 symptomatic toxicity (overall: 88.9% v 94.8%, P = .035; core symptoms: 83.4% v 91.7%, P = .001). The results for grade ≥ 3 toxicity were comparable but not significant (P > .05). CONCLUSION: In the presence of a high baseline symptom burden, a GA intervention for older patients with advanced cancer reduces patient-reported symptomatic toxicity.

Integrating Geriatric Assessment Measures into National Cancer Institute Clinical Trials.

To improve the care of older adults with cancer, the traditional approach to clinical trial design needs to be reconsidered. Older adults are underrepresented in clinical trials with limited or no information on geriatric-specific factors, such as cognition or comorbidities. To address this knowledge gap and increase relevance of therapeutic clinical trial results to the real-life population, integration of aspects relevant to older adults is needed in oncology clinical trials. Geriatric assessment (GA) is a multidimensional tool comprising validated measures assessing specific health domains that are more frequently affected in older adults, including aspects related to physical function, comorbidity, medication use (polypharmacy), cognitive and psychological status, social support, and nutritional status. There are several mechanisms for incorporating either the full GA or specific GA measures into oncology therapeutic clinical trials to contribute to the overarching goal of the trial. Mechanisms include utilizing GA measures to better characterize the trial population, define trial eligibility, allocate treatment receipt within the context of the trial, develop predictive models for treatment outcomes, guide supportive care strategies, personalize care delivery, and assess longitudinal changes in GA domains. The objective of this manuscript is to review how GA measures can contribute to the overall goal of a clinical trial, to provide a framework to guide the selection and integration of GA measures into clinical trial design, and ultimately enable accrual of older adults to clinical trials by facilitating the design of trials tailored to older adults treated in clinical practice.

Using Geriatric Assessment to Guide Conversations Regarding Comorbidities Among Older Patients With Advanced Cancer.

PURPOSE: Older patients with advanced cancer often have comorbidities that can worsen their cancer and treatment outcomes. We assessed how a geriatric assessment (GA)-guided intervention can guide conversations about comorbidities among patients, oncologists, and caregivers. METHODS: This secondary analysis arose from a nationwide, multisite cluster-randomized trial (ClinicalTrials.gov identifier: NCT02107443). Eligible patients were ≥ 70 years, had advanced cancer (solid tumors or lymphoma), and had impairment in at least one GA domain (not including polypharmacy). Oncology practices (n = 30) were randomly assigned to usual care or intervention. All patients completed a GA; in the intervention arm, a GA summary with recommendations was provided to their oncologist. Patients completed an Older Americans Resources and Services Comorbidity questionnaire at screening. The clinical encounter following GA was audio-recorded, transcribed, and coded for topics related to comorbidities. Linear mixed models examined the effect of the intervention on the outcomes adjusting for practice site as a random effect. RESULTS: Patients (N = 541) were 76.6 ± 5.2 years old; 94.6% of patients had at least one comorbidity with an average of 3.2 ± 1.9. The intervention increased the average number of conversations regarding comorbidities per patient from 0.52 to 0.99 (P < .01). Moreover, there were a greater number of concerns acknowledged (0.52 v 0.32; P = .03) and there was a 2.4-times higher odds of having comorbidity concerns addressed via referral, handout, or other modes (95% CI, 1.3 to 4.3; P = .004). Most oncologists in the intervention arm (76%) discussed comorbidities in light of the treatment plan, and 41% tailored treatment plans. CONCLUSION: Providing oncologists with a GA-guided intervention enhanced communication regarding comorbidities.

Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study.

BACKGROUND: Older adults with advanced cancer are at a high risk for treatment toxic effects. Geriatric assessment evaluates ageing-related domains and guides management. We examined whether a geriatric assessment intervention can reduce serious toxic effects in older patients with advanced cancer who are receiving high risk treatment (eg, chemotherapy). METHODS: In this cluster-randomised trial, we enrolled patients aged 70 years and older with incurable solid tumours or lymphoma and at least one impaired geriatric assessment domain who were starting a new treatment regimen. 40 community oncology practice clusters across the USA were randomly assigned (1:1) to the intervention (oncologists received a tailored geriatric assessment summary and management recommendations) or usual care (no geriatric assessment summary or management recommendations were provided to oncologists) by means of a computer-generated randomisation table. The primary outcome was the proportion of patients who had any grade 3-5 toxic effect (based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4) over 3 months. Practice staff prospectively captured toxic effects. Masked oncology clinicians reviewed medical records to verify. The study was registered with ClinicalTrials.gov, NCT02054741. FINDINGS: Between July 29, 2014, and March 13, 2019, we enrolled 718 patients. Patients had a mean age of 77·2 years (SD 5·4) and 311 (43%) of 718 participants were female. The mean number of geriatric assessment domain impairments was 4·5 (SD 1·6) and was not significantly different between the study groups. More patients in intervention group compared with the usual care group were Black versus other races (40 [11%] of 349 patients vs 12 [3%] of 369 patients; p<0·0001) and had previous chemotherapy (104 [30%] of 349 patients vs 81 [22%] of 369 patients; p=0·016). A lower proportion of patients in the intervention group had grade 3-5 toxic effects (177 [51%] of 349 patients) compared with the usual care group (263 [71%] of 369 patients; relative risk [RR] 0·74 (95% CI 0·64-0·86; p=0·0001). Patients in the intervention group had fewer falls over 3 months (35 [12%] of 298 patients vs 68 [21%] of 329 patients; adjusted RR 0·58, 95% CI 0·40-0·84; p=0·0035) and had more medications discontinued (mean adjusted difference 0·14, 95% CI 0·03-0·25; p=0·015). INTERPRETATION: A geriatric assessment intervention for older patients with advanced cancer reduced serious toxic effects from cancer treatment. Geriatric assessment with management should be integrated into the clinical care of older patients with advanced cancer and ageing-related conditions. FUNDING: National Cancer Institute.

Relationships of self-perceived age with geriatric assessment domains in older adults with cancer.

OBJECTIVES: Older self-perceived age is associated with poor health and higher healthcare utilization in the geriatric population. We evaluated the associations of self-perceived age with geriatric assessment (GA) domain impairments in older adults with cancer. METHODS: This was a secondary analysis of baseline data from a GA cluster-randomized trial (URCC 13070; PI: Mohile). We included patients aged ≥70 with incurable stage III/IV solid tumor or lymphoma considering or receiving treatment and had ≥1 GA domain impairment other than polypharmacy. Multivariate analyses were used to evaluate the associations of age difference between chronological and self-perceived age (categorized into "feeling younger than chronological age" vs. "feeling the same or older than their chronological age") with GA domain impairments. RESULTS: We included 533 patients; mean age was 76.6 (SD 5.2). On multivariate analyses, compared to those who felt younger than their chronological age, those who felt the same or older were more likely to have impairments in physical performance [Adjusted Odds Ratio (AOR) 5.42, 95% Confidence Interval (CI) 1.69-17.40)], functional status (AOR 2.31, 95% CI 1.73-3.07), comorbidity (AOR 1.62, 95% CI 1.20-2.19), psychological health (AOR 2.62, 95% CI 1.85-3.73), and nutrition (AOR 1.65, 95% CI 1.20-2.28). They were also more likely to screen positively for polypharmacy (AOR 1.86, 95% CI 1.30-2.65). CONCLUSIONS: Older adults with cancer who felt the same or older than their chronological age were more likely to have GA domain impairments. Further studies are needed to better understand the relationships between self-perceived age, aging-related conditions, and outcomes in this population.

Geriatric assessment and treatment outcomes in older adults with cancer receiving immune checkpoint inhibitors.

OBJECTIVES: Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, but outcomes in older adults are not well defined. We evaluated the associations of geriatric assessment (GA) domains with treatment-related outcomes in older adults with solid tumors receiving ICIs. METHODS: We performed a single-center, retrospective study of patients age ≥65 years diagnosed with solid tumors who received ICIs and were evaluated with a GA from January 2011 to April 2017. Using Wilcoxon rank sum test, we examined the associations of GA domains and treatment-related outcomes, including the number of ICI cycles received, best response, immune-related adverse events (irAEs), and hospitalizations during ICI treatment. RESULTS: We identified 28 patients (median age at ICI treatment = 78 years, range 66-93); 60% had Eastern Cooperative Oncology Group (ECOG) Performance Status of ≥2; 39% had lung cancer; 89% had stage IV cancer; and 50% received pembrolizumab. Seventy-five percent had at least one GA domain impairment. Patients with any instrumental activities of daily living (IADL) impairment received fewer cycles of ICI (median: 2.0 vs. 7.0 cycles, p = 0.02). In this small sample, neither age nor GA domain measures were associated with best response, irAEs, or hospitalization during ICI treatment. CONCLUSIONS: Older adults treated with ICIs had a high prevalence of impairments in GA domains, and IADL impairments were associated with shorter duration of ICI treatment. Future prospective studies are needed to evaluate the role of the GA further in this vulnerable patient population in the immunotherapy era.

Communication With Older Patients With Cancer Using Geriatric Assessment: A Cluster-Randomized Clinical Trial From the National Cancer Institute Community Oncology Research Program.

Importance: Older patients with cancer and their caregivers worry about the effects of cancer treatment on aging-related domains (eg, function and cognition). Quality conversations with oncologists about aging-related concerns could improve patient-centered outcomes. A geriatric assessment (GA) can capture evidence-based aging-related conditions associated with poor clinical outcomes (eg, toxic effects) for older patients with cancer. Objective: To determine whether providing a GA summary and GA-guided recommendations to oncologists can improve communication about aging-related concerns. Design, Setting, and Participants: This cluster-randomized clinical trial enrolled 541 participants from 31 community oncology practices within the University of Rochester National Cancer Institute Community Oncology Research Program from October 29, 2014, to April 28, 2017. Patients were aged 70 years or older with an advanced solid malignant tumor or lymphoma who had at least 1 impaired GA domain; patients chose 1 caregiver to participate. The primary outcome was assessed on an intent-to-treat basis. Interventions: Oncology practices were randomized to receive either a tailored GA summary with recommendations for each enrolled patient (intervention) or alerts only for patients meeting criteria for depression or cognitive impairment (usual care). Main Outcomes and Measures: The predetermined primary outcome was patient satisfaction with communication about aging-related concerns (modified Health Care Climate Questionnaire [score range, 0-28; higher scores indicate greater satisfaction]), measured after the first oncology visit after the GA. Secondary outcomes included the number of aging-related concerns discussed during the visit (from content analysis of audiorecordings), quality of life (measured with the Functional Assessment of Cancer Therapy scale for patients and the 12-Item Short Form Health Survey for caregivers), and caregiver satisfaction with communication about aging-related patient concerns. Results: A total of 541 eligible patients (264 women, 276 men, and 1 patient did not provide data; mean [SD] age, 76.6 [5.2] years) and 414 caregivers (310 women, 101 men, and 3 caregivers did not provide data; mean age, 66.5 [12.5] years) were enrolled. Patients in the intervention group were more satisfied after the visit with communication about aging-related concerns (difference in mean score, 1.09 points; 95% CI, 0.05-2.13 points; P = .04); satisfaction with communication about aging-related concerns remained higher in the intervention group over 6 months (difference in mean score, 1.10; 95% CI, 0.04-2.16; P = .04). There were more aging-related conversations in the intervention group's visits (difference, 3.59; 95% CI, 2.22-4.95; P < .001). Caregivers in the intervention group were more satisfied with communication after the visit (difference, 1.05; 95% CI, 0.12-1.98; P = .03). Quality of life outcomes did not differ between groups. Conclusions and Relevance: Including GA in oncology clinical visits for older adults with advanced cancer improves patient-centered and caregiver-centered communication about aging-related concerns. Trial Registration: ClinicalTrials.gov identifier: NCT02107443.

Communication about geriatric assessment domains in advanced cancer settings: "Missed opportunities".

OBJECTIVES: Older patients with advanced cancer often have age-related health issues (e.g., memory impairment) that influence their cancer treatment decisions. Communication about these age-related concerns can potentially lead to further assessment and subsequent clinical interventions to improve treatment decision-making and patients' quality of life. Yet, little is known about the communication of age-related concerns between oncologists, patients, and caregivers. MATERIALS AND METHODS: This study is a secondary analysis of data from the Values and Options in Cancer Care (VOICE) study. Audio-recorded and transcribed outpatient clinical oncology encounters with 37 patients with advanced cancer ≥60 years of age were content-analyzed. Two trained coders used a structured coding scheme based on pre-specified geriatric assessment (GA) domains to examine the transcripts for the frequency and quality of communication about age-related concerns. Atlas.ti version 6 was used for all analyses. RESULTS: The median age of the patients was 66 years (range = 60-90 years); patients were mostly female (26/37), married (22/37), and White (36/37). Out of 37 audio-recorded visits, 31 had at least one mention of an age-related concern with a total of 70 mentions. Oncologists initiated communication about age-related concerns half of the time (53%). When age-related concerns were mentioned, half of the time (50%) the oncologist did not implement further evidence-based interventions to address the age-related concern (e.g., conduct a cognitive screen for a memory concern). CONCLUSION: Interventions are needed to improve the frequency and quality of the communication about age-related concerns to improve the care of older adults with cancer.

Geriatric assessment with management intervention in older adults with cancer: a randomized pilot study.

BACKGROUND: Older adults receiving cancer therapy have heightened risk for treatment-related toxicity. Geriatric assessment (GA) can identify impairments, which may contribute to vulnerability and adverse outcomes. GA management interventions can address these impairments and have the potential to improve outcomes when implemented. METHODS: We conducted a randomized pilot study comparing GA with management interventions versus usual care in patients with stage III/IV solid tumor malignancies (N = 71). In all patients, a trained coordinator conducted and scored a baseline GA with pre-determined cutoffs for impairment. For patients randomized to the intervention arm, an algorithm was used to identify GA management recommendations based upon identified impairments. Recommendations were relayed to the primary oncologist for implementation. GA was repeated at 3 months. The primary outcome was grade 3-5 chemotherapy toxicity. Secondary outcomes included feasibility, hospitalizations, dose reductions, dose delays, and early treatment discontinuation. RESULTS: The mean participant age was 76 (70-89). The total number of GA management recommendations relayed was 409, of which 35.4% were implemented by the primary oncologist. Incidence of grade 3-5 chemotherapy toxicity did not differ between the two groups. Prevalence of hospitalization, dose reductions, dose delays, and early treatment discontinuation also did not differ between the two groups. CONCLUSIONS: An algorithm can be used to guide GA management recommendations in older adults with cancer. However, reliance upon the primary oncologist for execution resulted in a low prevalence of implementation. Future work should aim to understand barriers to implementation and explore alternate models of implementing geriatric-focused care for older adults with cancer.

Cancer Screening in Older Adults.

When screening for cancer in older adults, it is important to consider the risks of screening, how long it takes to benefit from screening, and the patient's comorbidities and life expectancy. Delivering high-value care requires the consideration of evidence-based screening guidelines and careful selection of patients. This article considers the impact of cancer. It explores perspectives on the costs of common cancer screening tests, illustrates how using life expectancy can help clinicians determine who will benefit most from screening, and provides tools to help clinicians discuss with their older patients when it may be appropriate to stop screening for cancer.

Geriatric assessment with management in cancer care: Current evidence and potential mechanisms for future research.

Older adults with cancer represent a complex patient population. Geriatric assessment (GA) is recommended to evaluate the medical and supportive care needs of this group. "GA with management" is a term encompassing the resultant medical decisions and interventions implemented in response to vulnerabilities identified on GA. In older, non-cancer patients, GA with management has been shown to improve a variety of outcomes, such as reducing functional decline and health care utilization. However, the role of GA with management in the older adult with cancer is less well established. Rigorous clinical trials of GA with management are necessary to develop an evidence base and support its use in the routine oncology care of older adults. At the recent U-13 conference, "Design and Implementation of Intervention Studies to Improve or Maintain Quality of Survivorship in Older and/or Frail Adults with Cancer," a session was dedicated to developing research priorities in GA with management. Here we summarize identified knowledge gaps in GA with management studies for older patients with cancer and propose areas for future research.

Association of falls with health-related quality of life (HRQOL) in older cancer survivors: A population based study.

OBJECTIVE: To examine the association between falls and health-related quality of life (HRQOL) in older cancer survivors. MATERIALS AND METHODS: Using the 2006-2011 Surveillance, Epidemiology, and End Results cancer registry system and the Medicare Health Outcomes Survey (SEER-MHOS) linkage database, a cross-sectional analysis was performed including 17,958 older cancer survivors. Multivariable regression models were used to evaluate the association of falls with HRQOL measured by the physical component summary (PCS) and mental component summary (MCS) scores on the Veteran RAND 12-item health survey after controlling for demographic, health- and cancer-related factors. A longitudinal analysis using the analysis of covariance (ANCOVA) models was also conducted comparing changes in HRQOL of older cancer survivors who fell with HRQOL of older patients with cancer who did not fall. RESULTS: In the cross-sectional analysis, 4524 (25%) cancer survivors who fell reported a significantly lower PCS (-2.18; SE=0.16) and MCS (2.00; SE=0.17) scores compared to those who did not (N=13,434). In the longitudinal analysis, after adjusting for baseline HRQOL scores and covariates, patients who fell reported a decline in mean HRQOL scores of both PCS (-1.54; SE=0.26) and MCS (-1.71; SE=0.27). Presence of depression, functional impairment and comorbidities was significantly associated with lower HRQOL scores. CONCLUSION: Falls are associated with lower HRQOL scores and are associated with a significant prospective decline in HRQOL in older cancer survivors. Further research is necessary to determine if assessment and intervention programs can help improve HRQOL by reducing the likelihood of falls.

Geriatric Assessment-Guided Care Processes for Older Adults: A Delphi Consensus of Geriatric Oncology Experts.

BACKGROUND: Structured care processes that provide a framework for how oncologists can incorporate geriatric assessment (GA) into clinical practice could improve outcomes for vulnerable older adults with cancer, a growing population at high risk of toxicity from cancer treatment. We sought to obtain consensus from an expert panel on the use of GA in clinical practice and to develop algorithms of GA-guided care processes. METHODS: The Delphi technique, a well-recognized structured and reiterative process to reach consensus, was used. Participants were geriatric oncology experts who attended NIH-funded U13 or Cancer and Aging Research Group conferences. Consensus was defined as an interquartile range of 2 or more units, or 66.7% or greater, selecting a utility/helpfulness rating of 7 or greater on a 10-point Likert scale. For nominal data, consensus was defined as agreement among 66.7% or more of the group. RESULTS: From 33 invited, 30 participants completed all 3 rounds. Most experts (75%) used GA in clinical care, and the remainder were involved in geriatric oncology research. The panel met consensus that "all patients aged 75 years or older and those who are younger with age-related health concerns" should undergo GA and that all domains (function, physical performance, comorbidity/polypharmacy, cognition, nutrition, psychological status, and social support) should be included. Consensus was met for how GA could guide nononcologic interventions and cancer treatment decisions. Algorithms for GA-guided care processes were developed. CONCLUSIONS: This Delphi investigation of geriatric oncology experts demonstrated that GA should be performed for older patients with cancer to guide care processes.

Comprehensive geriatric assessment in oncology.

The incidence of cancer increases with advanced age and the majority of cancer deaths are in patients aged ≥ 65. The geriatric population is a heterogeneous group and a patient's chronologic age does not always correlate with underlying physiologic status. Oncologists need to be able to obtain information on physiologic and functional capacity in older patients in order to provide safe and effective treatment recommendations. The Comprehensive Geriatric Assessment (CGA) is a compilation of validated tools that predict morbidity and mortality in community-dwelling older adults. The various components of the CGA have also been shown to influence clinical decision-making and predict outcomes in older cancer patients. The combined data from the CGA can be used to stratify patients into risk categories to better predict their tolerance to treatment and risk for chemotherapy toxicity. However, the CGA is a comprehensive tool requiring significant time and training to perform. A variety of screening tools have been developed which may be useful in the general oncology practice setting to identify patients that may benefit from further testing and intervention. This chapter will review the components and predictive value of CGA in older cancer patients, with emphasis on how CGA can practically be incorporated into clinical practice.