TOward a comPrehensive supportive Care intervention for Older men with metastatic Prostate cancer (TOPCOP3): A pilot randomized controlled trial and process evaluation.

INTRODUCTION: Current management of metastatic prostate cancer (mPC) includes androgen receptor axis-targeted therapy (ARATs), which is associated with substantial toxicity in older adults. Geriatric assessment and management and remote symptom monitoring have been shown to reduce toxicity and improve quality of life in patients undergoing chemotherapy, but their efficacy in patients being treated with ARATs has not been explored. The purpose of this study is to examine whether these interventions, alone or in combination, can improve treatment tolerability and quality of life (QOL) for older adults with metastatic prostate cancer on ARATs. MATERIALS AND METHODS: TOPCOP3 is a multi-centre, factorial pilot clinical trial coupled with an embedded process evaluation. The study includes four treatment arms: geriatric assessment and management (GA + M); remote symptom monitoring (RSM); geriatric assessment and management plus remote symptom monitoring; and usual care and will be followed for six months. The aim is to recruit 168 patients between two cancer centres in Toronto, Canada. Eligible participants will be randomized equally via REDCap. Participants in all arms will complete a comprehensive baseline assessment upon enrollment following the Geriatric Core dataset, as well as follow-up assessments at 1.5, 3, 4.5, and 6 months. The co-primary outcomes will be grade 3-5 toxicity and QOL. Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. QOL will be measured by patient self-reporting using the EuroQol 5 dimensions of health questionnaire. Secondary outcomes include fatigue, insomnia, and depression. Finally, four process evaluation outcomes will also be observed, namely feasibility, fidelity, and acceptability, along with implementation barriers and facilitators. DISCUSSION: Data will be collected to observe the effects of GA + M and RSM on QOL and toxicities experienced by older adults receiving ARATs for metastatic prostate cancer. Data will also be collected to help the design and conduct of a definitive multicentre phase III randomized controlled trial. This study will extend supportive care interventions for older adults with cancer into new areas and inform the design of larger trials. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov (registration number: NCT05582772).

Defining an Abnormal Geriatric Assessment: Which Deficits Matter Most?

At present, there is no clear definition of what constitutes an abnormal geriatric assessment (GA) in geriatric oncology. Various threshold numbers of abnormal GA domains are often used, but how well these are associated with treatment plan modification (TPM) and whether specific GA domains are more important in this context remains uncertain. A retrospective review of the geriatric oncology clinic database at Princess Margaret Cancer Centre in Toronto, Canada, including new patients seen for treatment decision making from May 2015 to June 2022, was conducted. Logistic regression modelling was performed to determine the association between various predictor variables (including the GA domains and numerical thresholds) and TPM. The study cohort (n = 736) had a mean age of 80.7 years, 46.1% was female, and 78.3% had a VES-13 score indicating vulnerability (≥3). In the univariable analysis, the best-performing threshold number of abnormal domains based on area under the curve (AUC) was 4 (AUC 0.628). The best-performing multivariable model (AUC 0.704) included cognition, comorbidities, and falls risk. In comparison, the multivariable model with the sole addition of the threshold of 4 had an AUC of 0.689. Overall, an abnormal GA may be best defined as one with abnormalities in the domains of cognition, comorbidities, and falls risk. The optimal numerical threshold to predict TPM is 4.

Cancer treatment-related decision-making among culturally and linguistically diverse older adults with cancer: A scoping review by the International Society of Geriatric Oncology Nursing and Allied Health Interest Group.

INTRODUCTION: Countries with large economies are observing a growing number of culturally and linguistically diverse (CALD) older adults, many of whom will be affected by cancer. Little is known about the experiences and factors that influence cancer treatment decision-making in this population. The purposes of this scoping review are: (1) to summarize the published literature on cancer treatment-related decision-making with this population; and (2) to identify potential differences in how cancer treatment decisions are made compared to non-CALD older adults with cancer. MATERIALS AND METHODS: We conducted a scoping review following Arksey and O'Malley and Levac methods, Preferred Reporting Items for Systematic Reviews and Meta-Analyses Scoping Review Guidelines. We conducted a comprehensive multidatabase search, screening 1,139 titles/abstracts. Following data abstraction, we analyzed the data using tabular and narrative summary. RESULTS: We extracted data from six studies that met the inclusion criteria: four quantitative and two qualitative; five from the United States and one from Canada. Three themes were identified: (1) barriers to decision-making, (2) the influence of family and friends on decisionmaking, and (3) differences in uptake and types of treatment received between CALD and non-CALD older adults. DISCUSSION: This comprehensive review of treatment decision-making among CALD older adults with cancer highlights the paucity of research in this area. The findings are limited to North American populations and may not represent experiences in other regions of the world. Future research should focus on studying their treatment-related decision-making experiences to improve the quality of care for this vulnerable population.

Validity of a self-administered G8 screening test for older patients with cancer.

INTRODUCTION: The Geriatric 8 (G8) is a brief cancer-specific tool which screens for patients who require a comprehensive geriatric assessment (CGA). The G8 test assesses patients on eight domains such as mobility, polypharmacy, age, and self-rated health. However, the current G8 requires a healthcare professional (nurse or physician) present to conduct the test, which limits its usefulness. The Self-G8 questionnaire (S-G8) is an adaptation of the original G8 test, assessing all the same domains, with questions modified to be appropriate for patients to self-complete. Our objective was to evaluate the performance of S-G8 compared to the G8 and CGA. MATERIALS AND METHODS: The initial S-G8 was designed by our team through review of the literature and questionnaire design principles, and was optimized through feedback from patients over the age of 70. The questionnaire subsequently underwent further refinement after undergoing pilot testing (N = 14). The diagnostic accuracy of the final iteration of the S-G8 was evaluated along with the standard G8 in a prospective cohort study (N = 52) in an academic geriatric oncology clinic at the Princess Margaret Cancer Centre, Toronto, Canada. Psychometric characteristics were evaluated including internal consistency, sensitivity, and specificity compared to the G8 and to the CGA. RESULTS: There was strong correlation between the G8 and S-G8 scores, with a Spearman correlation co-efficient of 0.76 (p < 0.001). Internal consistency was acceptable at 0.60. The frequency of abnormality (<14 score) for the G8 and S-G8 was 82.7% and 61.5%, respectively. The mean score for the original G8 and S-G8 was 11.9 and 13.5, respectively. The cut-off of 14 for the S-G8 yielded the best combination of sensitivity of 0.70 ± 0.07 and specificity of 0.78 ± 0.14 when compared to the G8. When compared to two or more abnormal domains on the CGA, the S-G8 performed at least as well as the G8 with a sensitivity of 0.77, specificity of 0.85, and a Youden's index of 0.62. DISCUSSION: The S-G8 questionnaire appears to be an acceptable alternative to the original G8 in identifying older adults with cancer who will benefit from a CGA. Large scale testing is warranted.

Implementation of clinical recommendations from the geriatric oncology clinic.

INTRODUCTION: While evidence on the value of routine geriatric assessment (GA) in cancer care for older patients is growing, there is limited data on the geriatric oncology (GO) clinic's specific recommendations and how they are implemented. In this study, we aimed to assess and evaluate the implementation of recommendations from the GO clinic at Princess Margaret Cancer Center, Toronto, Canada, within six months of the initial visit. MATERIALS AND METHODS: A retrospective chart review was conducted on 100 consecutive adults age 65+ visiting the GO clinic from 2018 to 2019. For each patient, we evaluated the number and type of recommendations from the GO clinic. Recommendations were grouped based on clinical judgement. Of the recorded recommendations, we measured the rate of implementation within six months of the initial visit including who implemented the recommendations and why recommendations were not implemented. Data were analyzed using descriptive statistics. RESULTS: One hundred patients visiting the GO clinic (mean age of 80.5 years, 62% male, 52% with planned curative intent, with the genitourinary site being most common) received a median of six recommendations (range of 2-12), regardless of sex, cancer stage, cancer site, and treatment intent. Medication optimization (27%), patient education (26%), and referral to allied health (14%) were the top recommendations from the GO clinic. At six-month follow-up, 83% of all recommendations were implemented, of which 94% were performed by the GO clinic team. Patient education was implemented at a 100% rate by the GO clinic at the time of initial assessment. GO follow-up visit and other diagnostic tests (hearing test, vision test) were the recommendations with the lowest implementation rates, at 51% and 31%, respectively. The most common reasons for recommendations not being implemented were patient transfer to palliative care/death and patient declining recommendations due to busy appointment schedules. DISCUSSION: A median of six recommendations were made per patient. The vast majority of recommendations were implemented, predominantly by the GO team. Overall, the study helps evaluate recommendations provided to patients visiting GO clinics, identify potential gaps, and assist with resource planning for optimal cancer care for older adults.

Performance of the SARC-F in identifying low grip strength and physical performance in older adults with cancer.

INTRODUCTION: Remote, online geriatric assessment (GA) is gaining attention in oncology. Most GA domains can be assessed remotely. However, there is limited evidence identifying reliable tools that can be used in lieu of objective measures of physical function, such as grip strength and physical performance during remote, online GA. In this prospective cohort study, we aimed to assess the performance of the SARC-F, a screening questionnaire for sarcopenia, in identifying low grip strength and the Short Physical Performance Battery (SPPB). Additionally, we assessed the satisfaction of clinical staff with using the SARC-F in the clinic. MATERIALS AND METHODS: Data were prospectively collected from older adults with cancer of any type and stage who underwent GA in the geriatric oncology clinic of a tertiary cancer centre. Following GA, patients were asked to complete the SARC-F tool. Spearman correlations were performed between objective measures of physical function, SARC-F domains, and SARC-F total score. Additionally, the sensitivity, specificity, positive predictive value, and negative predictive value were assessed to evaluate the performance of SARC-F to detect low grip strength and SPPB. RESULTS: Eighty (n = 80) older adults (mean age: 80 years) with cancer completed the SARC-F. A positive SARC-F was found in 31.3% of the cohort. Moderate correlations were found between the SPPB per point and Assistance in walking (r = -0.69), as well as the SPPB per point and total SARC-F score (r = -0.66). SARC-F exhibited moderate sensitivity in identifying low grip strength using the Foundation for the National Institutes of Health (FNIH) criteria (sensitivity: 64.3%) or the Sarcopenia Definitions and Outcomes Consortium (SDOC) criteria (sensitivity: 40.4%). However, specificity was high (>75%) regardless of the criteria applied. Similarly, moderate sensitivity (52.2%), but excellent specificity (97.1%) was found for SPPB. When low grip strength per FNIH was combined with low SPPB, SARC-F demonstrated high sensitivity (80%) and specificity (75.7%). DISCUSSION: SARC-F exhibited promising performance in identifying low grip strength per FNIH and low SPPB combined. To definitively assess the performance of the SARC-F in detecting low grip strength and SPPB, larger studies are warranted.

Do clinicians address impairments in muscle strength and physical performance for older adults with cancer?

INTRODUCTION: Low physical function is associated with adverse outcomes in older adults with cancer, but evidence on real-world, clinical management of low physical function in oncology is lacking. We explored whether impairments in muscle strength and/or physical performance triggered downstream management by clinicians, the types of recommended strategies, and the reasons for not providing a referral/strategy for addressing such impairments in older cancer survivors prior to treatment. MATERIALS AND METHODS: We conducted a retrospective, cross-sectional study of older adults who completed a comprehensive geriatric assessment (CGA) prior to cancer treatment in a tertiary cancer centre. Muscle strength and physical performance were assessed through grip strength and the Short Physical Performance Battery (SPPB), respectively. Patients who exhibited an impairment in grip strength and/or SPPB were classified as having abnormal objective physical function. Downstream management strategies and clinicians' reasons for not providing referrals were retrieved from clinical notes and an institutional database. RESULTS: In total, 515 older adults (mean age: 80.7 years) were included. Low grip strength and/or SPPB combined was observed in 66.4% (n = 342) of participants, of whom 54.1% (n = 185) received an acceptable intervention. However, 41.2% (n = 141) were not provided with a referral/strategy by clinicians to address such impairments following CGA. No reasons were provided in clinical notes for not addressing impairments in physical function for 100 participants (70.9%). DISCUSSION: Many older adults with cancer have impaired physical function prior to treatment. However, we found that such impairments are not systematically addressed by clinicians, and documentation was often suboptimal, identifying gaps in patient care that need to be addressed.

Impact of patients' sex in assessments and treatment recommendations in an older adult cancer clinic.

INTRODUCTION: In multiple settings, sex disparities have been seen in diagnosis, treatment, and outcomes. This study sought to determine whether there are sex differences in a geriatric oncology clinic concerning results of the comprehensive geriatric assessment (CGA) and treatment recommendations. MATERIALS AND METHODS: This is a retrospective cohort study including patients ≥65 years old referred for consultation on cancer treatment decision-making who underwent a CGA between July 2015 and December 2020, in a single Canadian academic geriatric oncology (GO) clinic. We examined differences by sex, stratified by disease site, stage, treatment intent, CGA results by domain, final treatment plan, and referrals for abnormal CGA findings. Differences were assessed using chi-square, Fisher's exact, or t-test as appropriate. Multivariate logistic regression was performed to examine whether sex impacted recommendations to reduce treatment intensity. RESULTS: In the study period, 328 patients were assessed in the GO clinic (mean age 81 years). The most common cancer types were gastrointestinal (42.1%), hematologic (18.3%), and head and neck (17.3%). More males than females were assessed in the GO clinic (62.2% versus 37.8%, respectively). This proportion did not change over time (p = 0.58). The GO clinic recommended to reduce treatment intensity in 140 cases (42.7%), with no difference between sexes in adjusted models (43.6% of females and 42.2% of males, p = 0.80). There were no differences in any CGA domain by sex. There were also no differences in referrals made by the GO clinic to optimize abnormal CGA domains by sex. DISCUSSION: Sex itself did not impact treatment decision-making, nor referrals to optimize abnormal CGA domains in our GO clinic using CGA-based care.

A scoping review of ageism towards older adults in cancer care.

INTRODUCTION: Ageism towards older adults with cancer may impact treatment decisions, healthcare interactions, and shape health/psychosocial outcomes. The purpose of this review is twofold: (1) To synthesize the literature on ageism towards older adults with cancer in oncology and (2) To identify interventions that address ageism in the healthcare context applicable to oncology. MATERIALS AND METHODS: We conducted a scoping review following Arksey and O'Malley and Levac methods and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We conducted an exhaustive multi-database search, screening 30,926 titles/abstracts. Following data abstraction, we conducted tabular, narrative, and textual synthesis. RESULTS: We extracted data on 133 papers. Most (n = 44) were expert opinions, reviews, and letters to editors highlighting the negative impacts of ageism, expressing the need for approaches addressing heterogeneity of older adults, and calling for increased clinical trial inclusion for older adults. Qualitative studies (n = 3) described healthcare professionals' perceived influence of age on treatment recommendations, whereas quantitative studies (n = 32) were inconclusive as to whether age-related bias impacted treatment recommendations/outcomes or survival. Intervention studies (n = 54) targeted ageism in pre/post-licensure healthcare professionals and reported participants' improvement in knowledge and/or attitudes towards older adults. No interventions were found that had been implemented in oncology. DISCUSSION: Concerns relating to ageism in cancer care are consistently described in the literature. Interventions exist to address ageism; however, none have been developed or tested in oncology settings. Addressing ageism in oncology will require integration of geriatric knowledge/interventions to address conscious and unconscious ageist attitudes impacting care and outcomes. Interventions hold promise if tailored for cancer care settings. 249/250.

The impact of pre-treatment muscle strength and physical performance on treatment modification in older adults with cancer following comprehensive geriatric assessment.

BACKGROUND: Grip strength (GS) and the short physical performance battery (SPPB) have been shown to predict clinical outcomes in older adults with cancer. However, whether pre-treatment GS and SPPB impact treatment decisions following comprehensive geriatric assessment (CGA) is poorly understood. Our objective was to assess the impact of low GS and/or SPPB on treatment modification to initially proposed treatment plans in older adults with cancer following CGA. METHODS: This was a retrospective cohort study of older adults who had undergone CGA before receiving cancer treatment. Data were retrieved from a prospective database in an academic cancer centre and medical records. Treatment modification following CGA was defined as reduced treatment intensity or transition from active treatment to supportive care. Multivariable logistic regression assessed the impact of pre-treatment GS and SPPB on treatment modification following CGA. RESULTS: In total, 515 older adults (mean age: 80.7y) who had undergone CGA prior to cancer treatment were included. Low muscle strength and/or physical performance was observed in 66.4% of participants. Treatment was modified in 49.5% of the cohort following CGA. Low GS and/or SPPB combined was predictive of treatment modification (OR = 1.77, 95%CI = 1.07-2.90, P = 0.025) in multivariable analysis. Additional predictors of treatment modification included palliative treatment intent, comorbidities and malnutrition. CONCLUSIONS: Low GS and/or SPPB combined prior to cancer treatment predicts treatment modification in older adults with cancer and may be useful in treatment decision-making. Management of poor muscle strength and physical performance should be offered to optimize patient care and potentially improve treatment outcomes.

Objective measures of physical function and their association with cognitive impairment in older adults with cancer prior to treatment.

INTRODUCTION: Objective measures of physical function are associated with cognitive function in community-dwelling older adults. Many older adults experience cognitive declines prior to cancer treatment initiation. Thus, it is unclear whether the association between low physical function and cognitive impairment is generalizable to older adults with cancer prior to treatment. Our objective was to examine whether objective measures of physical function were associated with cognitive impairment in geriatric oncology patients prior to treatment. MATERIALS AND METHODS: We used prospectively collected data from an institutional database within a cancer centre and electronic medical records of older adults who had undergone a geriatric assessment before cancer treatment. Objective measures of physical function included grip strength and the Short Physical Performance Battery (SPPB). Cognitive impairment was assessed via the Mini-Cog. Multivariable logistic regression was used to determine whether grip strength and SPPB were associated with cognitive impairment prior to cancer treatment in all patients, as well as in patients with moderate-to-high comorbidity as part of a sensitivity analysis. RESULTS: A total of 386 older adults (mean age 80.9 years) were included in the analysis. Most participants (65.3%) had low grip strength and/or low SPPB, whereas 42.2% were cognitively impaired. Neither low grip strength (odds ratio [OR] = 1.55, 95% confidence interval [CI] = 0.92-2.63, p = 0.097) nor low SPPB (OR = 1.29, 95%CI = 0.69-2.42, p = 0.41) alone or combined (OR = 1.05, 95%CI = 0.59-1.88, p = 0.85) were significantly associated with cognitive impairment in multivariable analyses of all patients. However, low SPPB was significantly associated with cognitive impairment in the sensitivity analysis restricted to patients with moderate-to-high comorbidity (OR = 4.05, 95%CI = 1.50-10.95, p = 0.006). Dependence in one or more instrumental activities of daily living [IADLs] was consistently associated with cognitive impairment in the main and sensitivity analyses. DISCUSSION: Low physical performance and IADL dependence are associated with cognitive impairment in patients with moderate-to-high comorbidity prior to cancer treatment. Scrutiny is advised for these patients to assess for possible cognitive impairment. Larger studies are warranted to confirm our findings.

Economic Evaluation of a Geriatric Oncology Clinic.

Geriatric assessment (GA) is supported by recent trials and guidelines yet rarely implemented due to a lack of resources. We performed an economic evaluation of a geriatric oncology clinic. Pre-GA proposed treatments and post-GA actual treatments were obtained from a detailed chart review of patients seen at a single academic centre. GA-based costs for investigations and referrals were calculated. Unit costs were obtained for surgical, radiation, systemic therapy, laboratory, imaging, physician, nursing, and allied health care (all in 2019 Canadian dollars). A six-month time horizon and government payer perspective were used. Consecutive patients aged 65 years or older (n = 152, mean age 82 y) and referred in the pre-treatment setting between July 2016 and June 2018 were included. Treatment plans were modified for 51% of patients. Costs associated with planned treatment were CAD 3,655,015. Costs associated with GA and related interventions were CAD 95,798. Final treatment costs were CAD 2,436,379. Net savings associated with the clinic were CAD 1,122,837, or CAD 7387 per patient seen. Findings were robust in multiple sensitivity analyses. Combined with mounting trial data demonstrating the clinical benefits of GA, our data can inform a strong business case for geriatric oncology clinics in health care environments similar to ours, but additional studies in diverse health care settings are warranted.

Quality of care of consultations from the geriatric oncology clinic: "Are we addressing the needs of patients?"

INTRODUCTION: A comprehensive geriatric assessment (CGA) is recommended for older adults with cancer in the pre-treatment setting to optimize care. A CGA systematically evaluates multiple domains to develop a holistic view of the patient's health and facilitate timely interventions to ameliorate patient outcomes. For a CGA to be most effective, optimization of each abnormal domain should occur. However, there is limited literature exploring this issue. MATERIALS AND METHODS: Consultations of patients seen in a Geriatric Oncology clinic from June 2015 to June 2018 were reviewed. The percentage of "no recommendations made" in the consultation letter following the identification of impairment in each of eight geriatric domains was calculated. Trends over time were examined by stratifying the data into three periods ("Year 1", "Year 2", and "Year 3") and conducting a logistic regression analysis. RESULTS: A total of 365 consultation notes were reviewed. The patients were predominately older (mean age 79.9 years), male (66.9%), with genitourinary (38.6%) or gastrointestinal (23.3%) cancers. The most common stage was metastatic (40.6%). The most common treatment intent and modality were palliative (50.4%) and hormonal (50.9%), respectively. The geriatric domains that had the greatest frequency of impairments were medication optimization (76.2%), functional status (68.8%), and falls risk (64.9%). The domains that had the highest frequency of "no recommendations made" following identification of impairment were nutrition (39.8%), social support (39.5%), and mood (26.4%). The prevalence of "no recommendations made" decreased over time in social support (54.6% in Year 1 to 27.8% in Year 3, p = 0.043) and possibly nutrition (53.1% in Year 1 to 34.3% in Year 3, p = 0.088) but not for mood (p = 0.64). CONCLUSIONS: Nutrition, social supports and mood were the CGA domains with the highest proportion of "no recommendations made" following an identification of impairment. This is the first quality assurance study to identify social supports, mood, and nutrition domains as less frequently addressed following an identification of an impairment amongst older patients with cancer. Subsequent prospective research is required to understand reasons for these observations and identification of barriers to address these geriatric domains amongst older adults with cancer.

Role of the vulnerable elders survey-13 screening tool in predicting treatment plan modification for older adults with cancer.

BACKGROUND: The Vulnerable Elders Survey (VES-13) is commonly used to identify older patients who may benefit from Comprehensive Geriatric Assessment (CGA) prior to cancer treatment. The optimal cut point of the VES-13 to identify those whose final oncologic treatment plan would change after CGA is unclear. We hypothesized that patients with high positive VES-13 scores (7-10)have a higher likelihood of a change in treatment compared to low positive scores (3-6). METHODS: Retrospective review of a customized database of all patients seen for pre-treatment assessment in an academic geriatric oncology clinic from June 2015 to June 2019. Various VES-13 cut points were analyzed to identify those individuals whose treatment was modified after CGA. Area under the curve (AUC) was calculated and subgroups of patients treated locally or systemically were also examined to determine if performance varied by treatment modality. RESULTS: We included 386 patients with mean age 81, 58% males. Gastrointestinal cancer was the most common site (31%) and 60% were planned to receive curative treatment. The final treatment plan was modified in 59% overall, with 52.7% modified with VES-13 scores 7-10, 50.8% with scores 3-6 and 28.1% with scores <3 (P = 0.002). VES-13 performance in predicting treatment modification was similar for cut points 3 (AUC 0.58), 4 (0.59), 5 (0.59), and 6 (0.59) and in those considering local treatment vs. chemotherapy. CONCLUSIONS: A positive VES-13 score was associated with final oncologic treatment plan modification. A high positive score was not superior to the conventional cut point of ≥3.