Study protocol for two stepped-wedge interventional trials evaluating the effects of holistic information technology-based patient-oriented management in older multimorbid patients with cancer: The GERONTE trials.

INTRODUCTION: Current hospital-based care pathways are generally single-disease centred. As a result, coexisting morbidities are often suboptimally evaluated and managed, a deficiency becoming increasingly apparent among older patients who exhibit heterogeneity in health status, functional abilities, frailty, and other geriatric impairments. To address this issue, our study aims to assess a newly developed patient-centred care pathway for older patients with multimorbidity and cancer. The new care pathway was based on currently available evidence and co-designed by end-users including health care professionals, patients, and informal caregivers. Within this care pathway, all healthcare professionals involved in the care of older patients with multimorbidity and cancer will form a Health Professional Consortium (HPC). The role of the HPC will be to centralise oncologic and non-oncologic treatment recommendations in accordance with the patient's priorities. Moreover, an Advanced Practice Nurse will act as case-manager by being the primary point of contact for the patient, thus improving coordination between specialists, and by organising and leading the consortium. Patient monitoring and the HPC collaboration will be facilitated by digital communication tools designed specifically for this purpose, with the added benefit of being customisable for each patient. MATERIALS AND METHODS: The GERONTE study is a prospective international, multicentric study consisting of two stepped-wedge trials performed at 16 clinical sites across three European countries. Each trial will include 720 patients aged 70 years and over with a new or progressive cancer (breast, lung, colorectal, prostate) and at least one moderate or severe multimorbidity. The patients in the intervention group will receive the new care pathway whereas patients in the control group will receive usual oncologic care. DISCUSSION: GERONTE will evaluate whether this kind of holistic, patient-oriented healthcare management can improve quality of life (primary outcome) and other valuable endpoints in older patients with multimorbidity and cancer. An ancillary study will assess in depth the socio-economic impact of the intervention and deliver concrete implementation guidelines for the GERONTE intervention care pathway. TRIAL REGISTRATION: FRONE: NCT05720910 TWOBE: NCT05423808.

How to incorporate chronic health conditions in oncologic decision-making and care for older patients with cancer? A survey among healthcare professionals.

PURPOSE: A substantial proportion of patients with cancer are older and experience multimorbidity. As the population is ageing, the management of older patients with multimorbidity including cancer will represent a significant challenge to current clinical practice. METHODS: This study aimed to (1) identify which chronic health conditions may cause change in oncologic decision-making and care in older patients and (2) provide guidance on how to incorporate these in decision-making and care provision of older patients with cancer. Based on a scoping literature review, an initial list of prevalent morbidities was developed. A subsequent survey among healthcare providers involved in the care for older patients with cancer assessed which chronic health conditions were relevant and why. RESULTS: A list of 53 chronic health conditions was developed, of which 34 were considered likely or very likely to influence decision-making or care according to the 39 healthcare professionals who responded. These conditions were further categorized into five patient profiles. From these conditions, five patient profiles were developed, namely, (1) a somatic profile consisting of cardiovascular, metabolic, and pulmonary disease, (2) a functional profile, including conditions that cause disability, dependency or a high caregiver burden, (3) a psychosocial profile, including cognitive impairment, (4) a nutritional profile also including digestive system diseases, and finally, (5) a concurrent cancer profile. All profiles were considered likely to impact decision-making with differences between treatment modalities. The impact on the care trajectory was generally considered less significant, except for patients with care dependency and psychosocial health problems. CONCLUSIONS: Chronic health conditions have various ways of influencing oncologic decision-making and the care trajectory in older adults with cancer. Understanding why specific chronic health conditions may impact the oncologic care trajectory can aid clinicians in the management of older patients with multimorbidity, including cancer.

The prognostic value of a geriatric risk score for older patients undergoing emergency surgery of colorectal cancer: A retrospective cohort study.

INTRODUCTION: Emergency surgery of colorectal cancer is associated with high mortality rates in older patients. We investigated whether information on four geriatric domains has prognostic value for 30-day mortality and postoperative morbidity including severe complications. MATERIALS AND METHODS: All consecutive patients aged 70 years or older who underwent emergency colorectal cancer surgery in six Dutch hospitals (2014-2017) were studied. Presence of geriatric risk factors was scored prior to surgery as either 0 (risk absent) or 1 (risk present) in each of four geriatric domains and summed up to calculate a sumscore with a value between 0 and 4. In addition, we separately investigated the use of a mobility aid. Primary outcome was 30-day mortality. Secondary outcomes were any postoperative complications and severe complications. Multivariable logistic regression model was used to evaluate the sumscore and outcomes. RESULTS: Two hundred seven patients were included. Median age was 79.4 years. One hundred seventy-five patients (76%) presented with obstruction, 22 (11%) with a perforation, and 17 (8%) with severe anemia. Mortality rates were 2.9%, 13.6%, and 29.6% for patients with a sumscore of 0, 1-2, and 3-4 respectively, with odds ratio (OR) 4.8 [95% confidence interval (CI) 1.03-22.95] and OR 10.6 [95% CI 1.99-56.34] for a sumscore of 1-2 and 3-4 respectively. Use of a mobility aid was associated with increased mortality OR 8.0 [95% CI 2.74-23.43] and severe complications OR 2.31 [95% CI 1.17-4.55]. DISCUSSION: This geriatric sumscore and the use of a mobility aid have strong association with 30-day mortality after emergency surgery of colorectal cancer. This could provide better insight into surgical risk and help select high-risk patients for alternative strategies.

Assessing patient-reported outcomes (PROs) and patient-related outcomes in randomized cancer clinical trials for older adults: Results of DATECAN-ELDERLY initiative.

As older adults with cancer are underrepresented in randomized clinical trials (RCT), there is limited evidence on which to rely for treatment decisions for this population. Commonly used RCT endpoints for the assessment of treatment efficacy are more often tumor-centered (e.g., progression-free survival). These endpoints may not be as relevant for the older patients who present more often with comorbidities, non-cancer-related deaths, and treatment toxicity. Moreover, their expectation and preferences are likely to differ from younger adults. The DATECAN-ELDERLY initiative combines a broad expertise, in geriatric oncology and clinical research, with interest in cancer RCT that include older patients with cancer. In order to guide researchers and clinicians coordinating cancer RCT involving older patients with cancer, the experts reviewed the literature on relevant domains to assess using patient-reported outcomes (PRO) and patient-related outcomes, as well as available tools related to these domains. Domains considered relevant by the panel of experts when assessing treatment efficacy in RCT for older patients with cancer included functional autonomy, cognition, depression and nutrition. These were based on published guidelines from international societies and from regulatory authorities as well as minimum datasets recommended to collect in RCT including older adults with cancer. In addition, health-related quality of life, patients' symptoms, and satisfaction were also considered by the panel. With regards to tools for the assessment of these domains, we highlighted that each tool has its own strengths and limitations, and very few had been validated in older adults with cancer. Further studies are thus needed to validate these tools in this specific population and define the minimum clinically important difference to use when developing RCTs in this population. The selection of the most relevant tool should thus be guided by the RCT research question, together with the specific properties of the tool.

Self-reported electronic symptom monitoring in older patients with multimorbidity treated for cancer: Development of a core dataset based on expert consensus, literature review, and quality of life questionnaires.

INTRODUCTION: In cancer care, symptom monitoring during treatment results in improved clinical outcomes such as improved quality of life, longer survival, and fewer hospital admissions. However, as the majority of patients with cancer are older and have multimorbidity, they may benefit from monitoring of additional symptoms. The aim of this study was to identify a core set of symptoms to monitor in older patients with multimorbidity treated for cancer, including symptoms caused by treatment side effects, destabilization of comorbidities, and functional decline. MATERIALS AND METHODS: During a scoping literature search, 17 quality of life questionnaires were used to select 53 possible symptoms to monitor. An expert panel of cancer and geriatrics specialists was asked to participate in multiple online surveys to indicate whether these symptoms were not relevant to monitor, only relevant to monitor in a specific patient group, or relevant to monitor in all patients. In a subsequent round the list was reduced and the panel indicated how frequently these symptoms should be monitored during cancer treatment and after cancer treatment completion. Finally, a digital consensus meeting was organised to decide when symptoms had to trigger a recommendation to the patient to get in touch with their medical team. RESULTS: In total, 30 healthcare professionals participated in the online surveys. After two rounds, a dataset of 19 symptoms related to cancer, cancer treatment, functional decline, and destabilization of comorbidities was agreed upon for monitoring. Five symptoms were selected for daily monitoring during treatment, seven for weekly, and seven for monthly. After treatment completion, the panel agreed upon less frequent reporting. Additionally, nine symptoms to be monitored only in patients with specific cancer types or treatment types were chosen, such as "cough up blood" in lung cancer. DISCUSSION: This study is the first to identify a core set of symptoms to monitor in older patients with multimorbidity treated for cancer. Future research is needed to investigate whether the monitoring of these symptoms is feasible and improves clinical outcomes in older patients with multimorbidity treated for cancer.

[The right care in the right place]. / De juiste zorg op de juiste plek.

Older patients who experience a fall may be admitted to hospital without a strict medical necessity. An unexplained fall incident requires thorough history taking and, if necessary, further investigation into the cause of the fall. Possible underlying multimorbidity must also be examined to prevent recurrence and complications. Admission to hospital without medical necessity is undesirable, but often unavoidable due to a lack of alternatives for patients who can no longer care for themselves in an acute situation. Reducing this unnecessary health care consumption is only possible if the options for care outside the hospital are expanded. In addition to regional cooperation to gain insight into available home care and places to stay, the use of unlabeled beds in care homes for further assessment of care needs and triage could help resolve this issue. In this way we can work together to provide the right care in the right place.

Geriatric assessment for older people with cancer: policy recommendations.

Most cancers occur in older people and the burden in this age group is increasing. Over the past two decades the evidence on how best to treat this population has increased rapidly. However, implementation of new best practices has been slow and needs involvement of policymakers. This perspective paper explains why older people with cancer have different needs than the wider population. An overview is given of the recommended approach for older people with cancer and its benefits on clinical outcomes and cost-effectiveness. In older patients, the geriatric assessment (GA) is the gold standard to measure level of fitness and to determine treatment tolerability. The GA, with multiple domains of physical health, functional status, psychological health and socio-environmental factors, prevents initiation of inappropriate oncologic treatment and recommends geriatric interventions to optimize the patient's general health and thus resilience for receiving treatments. Multiple studies have proven its benefits such as reduced toxicity, better quality of life, better patient-centred communication and lower healthcare use. Although GA might require investment of time and resources, this is relatively small compared to the improved outcomes, possible cost-savings and compared to the large cost of oncologic treatments as a whole.

Challenges of caring for older patients with multimorbidity including cancer.

INTRODUCTION: As the population is ageing, the number of older patients with multimorbidity including cancer continues to increase. To improve care for these patients, the European Union-funded project "Streamlined Geriatric and Oncological evaluation based on IC Technology" (GERONTE) was initiated to develop a new, patient-centred, holistic care pathway. The aim of this paper is to analyse what challenges are encountered in everyday clinical practice according to patients, their informal caregivers, and healthcare professionals as a starting point for the development of the care pathway. MATERIALS AND METHODS: An expert panel of cancer and geriatrics specialists participated in an online survey to answer what challenges they experience in caring for older patients with multimorbidity including cancer and what treatment outcomes could be improved. Furthermore, in-depth interviews with older patients and their informal caregivers were organised to assess what challenges they experience. RESULTS: Healthcare professionals (n = 36) most frequently mentioned the challenge of choosing the best treatment in light of the lack of evidence in this population and how to handle interactions between the (cancer) treatment and multimorbidities. Twelve patients and caregivers participated, and they most frequently mentioned challenges related to treatment outcomes, such as how to deal with symptoms of disease or treatment and how to maintain quality of life. From the challenges, five main themes emerged that should be taken into account when developing a new care pathway for older patients with multimorbidity including cancer. Two themes focus on decision making aspects such as personalized treatment recommendations and inclusion of non-oncologic information, two focus on patient support and monitoring to maintain quality of life and functioning, and one overarching theme addresses care coordination to prevent fragmentation of care. DISCUSSION: In conclusion, the management of older patients with multimorbidity including cancer is complex and although progress has been made on improving aspects of their care, challenges remain and patients are at risk of receiving inappropriate, unnecessary, and potentially harmful treatment. A patient-centred care pathway that integrates solutions to the five main themes and that moves away from a single-disease centred approach is needed.

Preferred and actual involvement of caregivers in oncologic treatment decision-making: A systematic review.

INTRODUCTION: Treatment decision-making in cancer is complex and many patients bring their caregiver to appointments to help them make those decisions. Multiple studies show the importance of involving caregivers in the treatment decision-making process. We aimed to explore the preferred and actual involvement of caregivers in the decision-making process of patients with cancer and to see if there are age or cultural background related differences in caregiver involvement. MATERIALS AND METHODS: A systematic review of Pubmed and Embase was performed on January 2, 2022. Studies containing numerical data regarding caregiver involvement were included, as were studies describing the agreement between patients and caregivers regarding treatment decisions. Studies assessing solely patients aged younger than 18 years old or terminally ill patients, and studies without extractable data were excluded. Risk of bias was assessed by two independent reviewers using an adapted version of the Newcastle-Ottawa scale. Results were analysed in two separate age groups, one <62 years and one ≥62 years. RESULTS: Twenty-two studies with a total of 11,986 patients and 6,260 caregivers were included in this review. A median of 75% of patients preferred caregivers to be involved in decision-making and a median of 85% of caregivers preferred to be involved. With regards to age groups, the preferred involvement of caregivers was more frequent in the younger study populations. With regards to geographical differences, studies performed in Western countries showed a lower preference for caregiver's involvement compared to studies from Asian countries. A median of 72% of the patients reported the caregiver was actually involved in the treatment decision-making and a median of 78% of the caregivers reported they were actually involved. The most important role of caregivers was to listen and provide emotional support. DISCUSSION: Patients and caregivers both want caregivers to be involved in the treatment decision-making process and most caregivers are actually involved. An ongoing dialogue between clinicians, patients and caregivers about decision-making is important to meet the individual patient's and caregiver's needs when involved in the decision-making process. Important limitations were a lack of studies in older patients and significant differences in outcome measures among studies.

Multidisciplinary decision-making and course of treatment in older patients with colorectal cancer: Effect of geriatrician input.

INTRODUCTION: We evaluated the effect of the inclusion of a geriatrician in the multidisciplinary cancer team (MDT) on decision-making for chemotherapy with curative intent in older patients with colorectal cancer. MATERIALS AND METHODS: We audited all patients aged 70 years and older with colorectal cancer discussed at MDT meetings between January 2010 and July 2018; selection was limited to those patients for whom guidelines recommended chemotherapy with curative intent as part of the primary treatment. We assessed how treatment decisions came about, and what the course of treatment was in the period before (2010-2013) and after (2014-2018) the geriatrician joined the MDT meetings. RESULTS: There were 157 patients included: 80 patients from 2010 to 2013 and 77 patients from 2014 to 2018. Age was mentioned significantly less often as the reason to withhold chemotherapy in the 2014-2018 cohort (10% vs 27% in 2010-2013, p = 0.04). Instead, patient preferences, physical condition, and comorbidities were the main reasons stated for withholding chemotherapy. Although a similar proportion of patients started chemotherapy in both cohorts, patients treated in 2014-2018 required many fewer treatment adaptations and were thus more likely to complete their treatments as planned. DISCUSSION: Over time and by incorporating a geriatrician's input, the multidisciplinary selection of older patients with colorectal cancer for chemotherapy with curative intent has improved. By basing decisions on an assessment of the patient's ability to tolerate treatment rather than using a more general parameter such as age, both overtreatment of not-so-fit patients and undertreatment of fit-but-old patients can be prevented.

A meta-analysis on the role older adults with cancer favour in treatment decision making.

INTRODUCTION: In the complex setting of oncological treatment decision making, balancing professional guidance while respecting patient involvement can be a challenge. We set out to assess the role adults with cancer favour in treatment decision making (TDM), including differences across age groups and change over time. MATERIALS AND METHODS: A systematic search was performed in MEDLINE and Embase, for studies on role preference of (older) adults with cancer in oncological treatment decision making. A meta-analysis was conducted based on Control Preference Scale (CPS) data, a questionnaire on patient role preference in TDM. RESULTS: This meta-analysis includes 33 studies reporting CPS data comprising 17,197 adults with cancer. Mean age was 60.6 years old for studies that specified age (24 studies, 6155 patients). During the last decade, patients' role preference shifted towards significantly more active involvement in TDM (p = 0.006). No age-dependent subgroup differences have been identified; both younger and older adults, defined as, respectively, below and above 65 years old, favour active involvement in treatment decision making. DISCUSSION: Over time, adults with cancer have shifted towards more active role preference in treatment decision making. In current cancer care, a large majority prefers taking an active role, irrespective of age.

The impact of surgery and adjuvant chemotherapy on health-related quality of life in patients with colon cancer: Changes at group level versus individual level.

OBJECTIVE: This study aims to evaluate changes in health-related quality of life (HR-QoL) 1 year after surgical treatment in patients with primary resectable colon cancer and to assess whether changes at group level differ from changes at individual level. In addition, we assess which characteristics are associated with a decline of HR-QoL. METHODS: Patients with primary resectable colon cancer who received surgical treatment and adjuvant chemotherapy if indicated were selected from the Prospective Dutch ColoRectal Cancer cohort (PLCRC). HR-QoL was assessed using EORTC-QLQ-C30 questionnaire before surgery and 12 months post-surgery. Outcomes were assessed at group and individual levels. Logistic regression analysis was conducted to assess which socio-demographic and clinical characteristics were associated with a clinically relevant decline of HR-QoL at 12 months. RESULTS: Of all 324 patients, the baseline level of HR-QoL summary score was relatively high with a mean of 88.1 (SD 11.4). On group level, the change of HR-QoL at 12 months varied between -2% for cognitive functioning and +9% for emotional functioning. On individual level, 15% of all patients experienced a clinically relevant decline in HR-QoL summary score at 12 months. Older age, comorbidity burden or the reception of adjuvant chemotherapy was independently associated with a decline of HR-QoL in one of the functional subscales of EORTC-QLQ-C30 at 12 months. CONCLUSION: Only trivial changes of HR-QoL were observed after colon cancer treatment on group level, whereas on individual level, at least 1 out of 10 patients experienced a decline of HR-QoL 12 months post-surgery. It is important to consider individual differences while making a treatment decision.

Advances in Geriatric Oncology: Exploring Practical Ways to Optimize Treatment in Older Patients with Cancer.

Cancer is a disease associated with aging, with patients over 70 accounting for 50% of newly diagnosed malignancies and 70% of all cancer deaths [...].

Validation of the ACS NSQIP surgical risk calculator in older patients with colorectal cancer undergoing elective surgery.

BACKGROUND: For clinical decision making it is important to identify patients at risk for adverse outcomes after colorectal cancer (CRC) surgery, especially in the older population. Because the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator is potentially useful in clinical practice, we performed an external validation in a Dutch multicenter cohort of patients ≥70 years undergoing elective non-metastatic CRC surgery. METHODS: We compared the ACS NSQIP calculator mean predicted risk to the overall observed rate of anastomotic leakage, return to operation room, pneumonia, discharge not to home, and readmission in our cohort using a one-sample Z-test. Calibration plots and receiver operating characteristic (ROC) curves were used to determine the calculator's performance. RESULTS: Six hundred eighty-two patients were included. Median age was 76.2 years. The ACS NSQIP calculator accurately predicted the overall readmission rate (predicted: 8.6% vs. observed: 7.8%, p = 0.456), overestimated the rate of discharge not to home (predicted:11.2% vs. observed: 7.0% p = 0.005) and underestimated the observed rate of all other outcomes. The calibration plots showed poor calibration for all outcomes. The ROC-curve showed an area under the curve (AUC) of 0.75 (95% confidence interval [CI] 0.67-0.83) for pneumonia and 0.70 (0.62-0.78) for discharge not to home. The AUC for all other outcomes was poor. CONCLUSIONS: The ACS NSQIP surgical risk calculator had a poor individual risk prediction (calibration) for all outcomes and only a fair discriminative ability (discrimination) to predict pneumonia and discharge not to home. The calculator might be considered to identify patients at high risk of pneumonia and discharge not to home to initiate additional preoperative interventions.

What Defines Quality of Life for Older Patients Diagnosed with Cancer? A Qualitative Study.

The treatment of cancer can have a significant impact on quality of life in older patients and this needs to be taken into account in decision making. However, quality of life can consist of many different components with varying importance between individuals. We set out to assess how older patients with cancer define quality of life and the components that are most significant to them. This was a single-centre, qualitative interview study. Patients aged 70 years or older with cancer were asked to answer open-ended questions: What makes life worthwhile? What does quality of life mean to you? What could affect your quality of life? Subsequently, they were asked to choose the five most important determinants of quality of life from a predefined list: cognition, contact with family or with community, independence, staying in your own home, helping others, having enough energy, emotional well-being, life satisfaction, religion and leisure activities. Afterwards, answers to the open-ended questions were independently categorized by two authors. The proportion of patients mentioning each category in the open-ended questions were compared to the predefined questions. Overall, 63 patients (median age 76 years) were included. When asked, "What makes life worthwhile?", patients identified social functioning (86%) most frequently. Moreover, to define quality of life, patients most frequently mentioned categories in the domains of physical functioning (70%) and physical health (48%). Maintaining cognition was mentioned in 17% of the open-ended questions and it was the most commonly chosen option from the list of determinants (72% of respondents). In conclusion, physical functioning, social functioning, physical health and cognition are important components in quality of life. When discussing treatment options, the impact of treatment on these aspects should be taken into consideration.

Patient Preferences for Treatment Outcomes in Oncology with a Focus on the Older Patient-A Systematic Review.

For physicians, it is important to know which treatment outcomes are prioritized overall by older patients with cancer, since this will help them to tailor the amount of information and treatment recommendations. Older patients might prioritize other outcomes than younger patients. Our objective is to summarize which outcomes matter most to older patients with cancer. A systematic review was conducted, in which we searched Embase and Medline on 22 December 2020. Studies were eligible if they reported some form of prioritization of outcome categories relative to each other in patients with all types of cancer and if they included at least three outcome categories. Subsequently, for each study, the highest or second-highest outcome category was identified and presented in relation to the number of studies that included that outcome category. An adapted Newcastle-Ottawa Scale was used to assess the risk of bias. In total, 4374 patients were asked for their priorities in 28 studies that were included. Only six of these studies had a population with a median age above 70. Of all the studies, 79% identified quality of life as the highest or second-highest priority, followed by overall survival (67%), progression- and disease-free survival (56%), absence of severe or persistent treatment side effects (54%), and treatment response (50%). Absence of transient short-term side effects was prioritized in 16%. The studies were heterogeneous considering age, cancer type, and treatment settings. Overall, quality of life, overall survival, progression- and disease-free survival, and severe and persistent side effects of treatment are the outcomes that receive the highest priority on a group level when patients with cancer need to make trade-offs in oncologic treatment decisions.

Factors associated with survival in older patients with stage I-III colorectal carcinoma who were not managed curatively in the Netherlands.

AIM: Some patients with stage I-III colorectal cancer (CRC) do not undergo tumor resection. Little is known about survival of these non-curatively managed patients. The aim of this study is to report all-cause mortality and to identify which factors are associated with survival in these patients. METHODS: A retrospective review of electronic medical records was performed in two hospitals in the Netherlands. Patients diagnosed with CRC without distant metastases (radiologically determined stage I-III) and managed without tumor resection between 2011 and 2017 were included. The primary outcome was all-cause mortality. The effect of several variables on survival was evaluated with a multivariate logistic regression. RESULTS: Of the 107 patients with stage I-III CRC that did not undergo resection of the primary tumor, 80% died within two years; median survival time was 8.5 months (IQR 2.5-22 months). Malnutrition risk (OR 6.36 (CI 1.21-33.25); p = 0.03) and comorbidity burden (OR 1.51 (CI 1.05-2.18 p = 0.03) were significantly associated with decreased survival after two years in a multivariate model. Age and disease stage were not. When treatment decision was mainly patient driven instead of based on the multi-disciplinary tumor board's decision, survival was longer (mean overall survival 16 months vs 10 months, respectively) p < 0.05. CONCLUSION: Survival of patients with radiologically determined stage I-III CRC who did not undergo surgical resection was approximately 20% at two years and associated with the number of comorbidities, malnutrition risk status and dependent living, but not with age or disease stage.