Clinical Research Directory

Implementation Pilot of Preoperative CGA Before Major Surgery

The goal of this clinical trial is to test whether a new implementation package can help older adults prepare for major surgery. The main question it aims to answer is: Can the implementation package help give more people access to this resource? Participants will be in two groups: older adults who are planning a major surgery and their medical and surgical healthcare providers. The results will be compared to a historic baseline.

Evaluation of GRAMPA Score Measuring Motor Abilities of Elderly Patients

In the field of geriatrics, the Standardized Geriatric Approach (SGA) which is the benchmark for assessing elderly patients, consists of evaluating the medical, psychological and functional capacity dimensions of the elderly subject, among others. After a review of the literature, investigators were unable to find any scales that could study the ability to perform basic movements in a comprehensive and graded manner. Scores that do assess certain aspects of motor abilities are not comprehensive, and are often based on self-reporting by the elderly or their relatives : * The AGGIR grid assesses dependency on the basis of activities performed or not performed. In addition, all basic movements are grouped together in a single item, which does not provide detailed information on the capabilities of elderly people. * The ADL score assesses activities of daily living, based on what patients declare. Only one item concerns basic movements, without detailing them. * The Tinetti score and Time up and go do not assess all basic movements, and require the patient to be able to stand to provide relevant information, whereas many geriatrics patients are unable to stand. Thus, investigators created a score to assess motor abilities more comprehensively that will include the following basic movements: * Getting up in bed * Turning on one side in bed * Sitting at the edge of the bed * Stand up * Move around a small perimeter (bedroom) * Sitting up * Return to bed The main objective is to evaluate of this study is to determine the inter-rater reliability of the GRAMPA score in elderly patients hospitalized in a geriatrics department.

Practical Geriatric Assessment in Older Adults With Non-Small Cell Lung Cancer Undergoing Stereotactic Body Radiation Therapy

National guidelines recommend that older adults with cancer undergo a special health assessment before starting cancer treatment. This type of assessment evaluates physical function, nutrition, social support, psychological well-being, medical conditions (both cancer-related and non-cancer-related), and cognitive function. The results can help doctors make better treatment decisions and determine whether additional support services-such as nutrition counseling, physical therapy, or social work-would be beneficial. Even though these assessments are recommended, they are not typically used because they need to be performed by a specialist and can take over an hour to complete. Given these challenges, a 10-15-minute assessment called the Practical Geriatric Assessment (PGA) was recently developed. The PGA can be completed by any healthcare provider and helps identify older adults who may need extra support alongside their cancer treatment. While the PGA has the potential to make geriatric assessments more accessible, the investigators do not yet know whether patients will find it useful or easy to complete. Additionally, it is unclear whether using the PGA will lead to more referrals for recommended supportive care services. This study aims to address these questions. The investigators will evaluate whether using the PGA impacts the number of patients referred to recommended supportive care services. Investigators will also evaluate how participants feel about completing the PGA, including how easy or difficult it is, and to assess the feasibility of implementing this survey on a larger scale. Finally, the investigators will use facial photographs and audio-visual data from the PGA to develop and evaluate artificial intelligence algorithm(s) to identify vulnerable patients who might benefit from additional supportive care services; namely, FaceAge, a validated deep learning model capable of estimating biological age from still facial images.

Complications of Surgical Geriatrics Hospitalized in the Orinoco Region

The life expectancy of the Colombian population is increasing. Older patients are frequently hospitalized and treated in surgical wards, and are treated as the general surgical population. However, geriatric patients are frequently found with additional comorbidities, besides the primary surgical diagnosis. Some diseases, like hip fractures, diverticulitis, and cancer, are common in this age range. The preoperative, intraoperative, and postoperative period requires a special care and planning to avoid complications related to the physical status, medications, and comorbidities. Studies about the geriatric surgical population are limited in the Orinoco region. The implementation of a comprehensive geriatric assesment in surgical services requires follow-up of outcomes.

Effects of Preoperative Whey Protein and Exercise Support on Recovery After Total Hip Arthroplasty

Objective: The aim of this project is to evaluate the effects of preoperative whey protein supplementation and a physical exercise program on postoperative recovery outcomes in patients undergoing total hip arthroplasty (THA). Specifically, inflammatory markers (CRP), nutritional status (albumin), mobilization time, length of hospital stay, and physical and social functioning will be assessed. As one of the first randomized controlled trials in Turkey to focus on the preoperative period and to evaluate a combined nutrition and exercise intervention in elderly surgical patients, this study holds pioneering significance in both clinical and academic contexts. Methods: This study is designed as a randomized controlled trial. The intervention group will receive whey protein supplementation and a home-based exercise program for 14 days preoperatively, while the control group will receive standard preoperative care. Data collection will be performed preoperatively and on postoperative days 3 and 5, focusing on metabolic and functional parameters. Expected Outcomes: The findings of this study are expected to contribute to the improvement of patient care through a multidisciplinary approach, inform health policy development, and provide a foundation for larger-scale clinical research in Turkey.

Promoting Aging and Thriving With HIV

The pilot is an intervention of a geriatric assessment and management tool (PATH) in outpatient HIV clinics.

Aspects of Adjuvant CDK4/6 Inhibitors in Older Breast Cancer Patients - Focusing on Geriatric Screening

Older breast cancer patients should not be categorically excluded from adjuvant therapies, including the recommended CDK4/6 inhibitors (CDK4/6i) administered in combination with endocrine therapy. Nevertheless, this population frequently presents with comorbidities that may increase susceptibility to treatment-related toxicities, including impacts on quality of life, which must be carefully considered when selecting therapeutic regimens. Given the limited representation of older patients in the clinical trials behind the recommendations for adjuvant CDK4/6i therapy, coupled with the uncertain magnitude of clinical benefit and the reported rates of toxicity and treatment discontinuation, it is essential to critically evaluate both efficacy and safety in this specific patient subgroup. National and international guidelines recommend the integration of geriatric assessments into routine clinical practice to facilitate individualized treatment decisions; however, such assessments are not yet widely implemented in many oncology departments and are not routinely in use to guide adjuvant CDK4/6i therapy. This study aims to investigate the implementation of geriatric assessments in older breast cancer patients (≥70 years) and to examine multiple dimensions of CDK4/6i treatment in this cohort, including short- and medium-term effects on quality of life, dose intensity, and clinical outcomes. By doing so, the investigators seek to more accurately delineate the benefits and risks of adjuvant CDK4/6i therapy in this specific patient population.

Validity - Reliability of Berg Balance Scale in Albanian Population

Cross-cultural adaptation, validity and Reliability of Berg Balance Scale in Albanian population

Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70)

The use of a geriatric assessment to inform oncologic care for older persons with cancer is an evidence-based practice that improves patient-clinician communication, reduces treatment-related toxicity, and is recommended by national guidelines. However, the implementation of a geriatric assessment can be time-consuming and burdensome, leading to suboptimal use in clinical practice. Developed and endorsed by the American Society for Clinical Oncology (ASCO), the Practical Geriatric Assessment (PGA) is designed to improve clinical usability and adoption, but its implementation in real-world settings has not been evaluated. The PACE-70 study aims to evaluate PGA implementation and resultant chemotherapy dose modification among older adults with advanced cancer treated in a community setting. An exploratory aim will evaluate how the PGA, body composition (via abdominal computed tomography scan) and step count monitoring (via FitBit) correlate with chemotherapy toxicity and other clinical outcomes.

The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM

Introduction: With the aging of the world population and the increasing incidence of type 2 diabetes mellitus (T2DM) with age, the number of elderly individuals living with diabetes has been considerably rising. It is known that uncontrolled T2DM negatively impacts various health outcomes, including geriatric outcomes such as sarcopenia, frailty, immobility, incontinence, and infections. Current medical literature fails to establish appropriate glycemic targets for different elderly profiles. Although guidelines emphasize the need to individualize targets, there is no concise tool to identify which individuals benefit from each therapeutic approach. Data suggest that frailty is the best predictor of negative outcomes in elderly patients living with T2DM. The Clinical Frailty Scale (CFS) and the 10-minute Targeted Geriatric Assessment (TaGA-10) are validated tools for prognosis in elderly patients and for identifying frail elderly individuals. Methods: Randomized controlled trial. Elderly individuals diagnosed with T2DM at a tertiary care outpatient clinic will be included. All enrolled patients will undergo geriatric assessment using CFS, TaGA-10, and Charlson Comorbidity Index. Patients will be randomized into usual care and intervention groups, and the intervention involves providing the geriatric assessment to the care team to support their decisions. The adequacy of the therapeutic approach will be measured in one week by reviewing the consult record or interviewing the physician. The clinical impact on the frequency of hypoglycemia, falls, infections, hospitalizations, and mortality will be evaluated at 3 and 6 months by telephone interviews. Discussion: Current guidelines recommend using age, comorbidities, cognitive, and functional status to individualize therapeutic targets in elderly patients with T2DM; however, it is possible that these variables alone may not be sufficient to classify all elderly individuals in their complexity adequately. A tool with such power and easy to use in clinical practice is necessary.

Care Pathways and Disparities in Care for Older Patients With Cancer: Typology, Determinants and Effect on Prognosis ( PASSAGE )

More than half of new cases of cancer in Europe in 2022 occurred in people aged over 70. In addition to cancer, the majority of older people have one or more illnesses that may interact with the treatment decision, cancer progression, tolerance and efficacy of treatments, quality of life, care pathway and survival. Furthermore, cancer treatments are most often evaluated in middle-aged subjects without severe disease, so the real-life management of older patients is often empirical. The general objective of the PASSAGE project is to assess the hospital care pathways of older patients with cancer treated at AP-HP by evaluating key elements of these pathways from both geriatric and therapeutic perspectives. Characterizing these care trajectories will help identify the most vulnerable patient profiles and potential disparities in access to care, with the goal of optimizing the management of elderly patients with cancer. The aims of this research are 1) to provide a better description of trends in the management of older cancer patients in routine clinical practice, and 2) to assess the impact of frailty, multimorbidity and the management of these patients on the prognosis of the disease.

Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care

The goal of this clinical trial is to determine whether a telehealth-delivered, geriatric assessment-guided supportive care program (GAIN-S) can improve health outcomes in older adults (age 65 and above) with solid tumors who are starting a new cancer treatment in Brazil. The main questions it aims to answer are: * Does GAIN-S improve physical function, as measured by activities of daily living (ADL), after three months? * Does GAIN-S reduce symptoms of depression and improve quality of life after three months? Researchers will compare patients receiving the GAIN-S intervention to those receiving standard care to see if the intervention leads to better physical function, fewer symptoms of depression, and improved quality of life. Participants will: * Complete a geriatric assessment (CARG-GA) before and after treatment. * Be randomized to either standard care or the GAIN-S intervention. * If assigned to GAIN-S, receive tailored supportive care via telehealth, which may include consultations with a psychologist, psychiatrist, nutritionist, geriatrician, exercise physiologist, or other specialists based on their needs.

Transcultural and Psychometric Validation of the Lubben Social Network Scale in Older Adults Living in the French West Indies

Social isolation and loneliness are common among older adults. They are associated with high morbidity and mortality, with an impact comparable to that of other known risk factors such as obesity, a sedentary lifestyle, smoking, etc. To date, there is no tool to measure social isolation and loneliness for patients living in the French West Indies. Applying unadapted and unvalidated tools to them without taking into account local ethnocultural realities would be risky. The investigators believe it is necessary to adapt the scales used to measure social isolation and loneliness for a population living in the French West Indies. Through this study, the investigators propose adapting the Lubben Social Network Scale, a social isolation questionnaire, for this population and conducting its psychometric validation.

Physical Training for Elderly Cancer Patients With Cachexia

The goal of the clinical trial is to evaluate the feasibility and efficacy of physical training for elderly cancer patients at risk of cancer cachexia. The main questions it aims to answer are: * Whether a physical training program is feasible in elderly cancer patients with cachexia? * What is the efficacy of a physical training program in reducing the severity of cancer cachexia in elderly cancer patients? Participants will receive a 12-week supervised patient-tailored intensity-modulated physical training and being assessed for the severity of cancer cachexia before and after the training.

The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients

The main goal is to elucidate the mechanistic coupling between inflammation and the ability to maintain skeletal muscle through physical exercise while hospitalized. We will investigate protein kinetics in patients who belong to one of three groups 1) high inflammatory state, 2) moderate inflammatory state and 3) low/no inflammation. We will further intervene in group 1 (high inflammatory state) with anti-inflammatory nutrition (primarily green-solution plant-based) to diminish activity in inflammatory pathways. The hypothesis is that inflammation will inhibit protein synthesis in skeletal muscle both in resting muscle and in strength trained skeletal musculature, and that a lowering of the inflammatory status by anti-inflammatory nutrition will enhance the exercise induced formation of new muscle mass. .

Development and Verification of a Screening Tool for Comprehensive Geriatric Assessment of Elderly Tumor Patients

This study is an observational research. 1. The study first conducted an electronic questionnaire survey among clinicians working in general and specialized hospitals at various levels nationwide to understand the implementation status and influencing factors of comprehensive geriatric assessment (CGA) for elderly cancer patients in China. 2. Based on the survey results, an interview outline was developed, and semi-structured interviews were conducted with professional doctors experienced in the diagnosis and treatment of elderly cancer patients to further explore the comprehensive factors influencing the implementation of CGA for this population. 3. According to the feedback from the semi-structured interviews, the survey results, and literature reports, the assessment dimensions required for the CGA screening tool were selected. An expert consultation survey questionnaire was designed around these dimensions, and the most suitable assessment items under each dimension were determined using the Delphi expert consultation method. 4. The G8 scale was used to assess elderly cancer patients. Items were selected based on their performance to form the screening tool. By setting thresholds and allocating weights for each item, CGA Screening Tool 1.0 was developed. 5. Pre-testing and modification of the screening tool were conducted. Investigators used the initially formed screening tool to conduct one-on-one patient testing. Feedback on the tool's clarity, relevance, clinical applicability (localization), and feasibility was obtained through consultation with a clinical expert panel to improve and refine its content and management process. This led to the revision and formation of CGA Screening Tool 2.0. 6. The reliability and validity of the CGA screening tool were verified using classical measurement theory to ensure the stability, reliability, and effectiveness of the scale tool in practical applications. 7. Patients were assessed using both CGA and the screening tool. External validation of Screening Tool 2.0 was performed using CGA as the gold standard to further evaluate the sensitivity, specificity, and accuracy of the screening tool. 8. Patients who participated in the assessment during the study were followed up to compare the correlation between different assessment results and patient completion of anti-tumor treatment, treatment efficacy, and the risk of related adverse reactions. The impact of the CGA screening tool on the implementation of CGA and its predictive ability for anti-tumor treatment were explored. Study data were obtained from the electronic medical record database and hospital information system of Sichuan Cancer Hospital, including clinicopathological features such as gender, age, clinical stage at diagnosis, and information related to anti-tumor treatment.

Geriatric Assessment (GA) for Elderly Patients Undergoing Allo-HSCT

This comprehensive, multidimensional evaluation assesses patient-related factors, disease-related factors, donor-related factors, and treatment-related factors. The study aims to identify potential risk factors influencing transplant outcomes in elderly patients and enhance the outcomes of allo-HSCT.

The Effect of Motor Image Training on Balance Performance in Geriatric Individuals

The goal of this study \[type of study: clinical trial\] is to was planned to investigate the effect of motor imagery training given to geriatric individuals with action observation on their balance performance and to compare these two methods. The main questions it aims to answer are: 1. Is virtual reality-based balance training given together with action observation and motor imagery for six weeks in geriatric individuals more effective in improving static balance than virtual reality-based balance training given alone? 2. Is virtual reality-based balance training given together with action observation and motor imagery for six weeks in geriatric individuals more effective in improving dynamic balance than virtual reality-based balance training given alone? 3. Is virtual reality-based balance training given together with motor imagery for six weeks in geriatric individuals more effective in increasing balance confidence than virtual reality-based balance training given alone? 46 geriatric individuals will be randomized into 2 groups. Along with action observation, motor imagery training and virtual reality-based balance training will be given to the study group. On the other hand, only virtual reality-based balance training will be given to the control group. All assessments will be repeated before and after the trainings. The trainings will be applied 2 days a week for 6 weeks. Each training session; 25 minutes for the control group and 45 minutes for the study group.

Geriatric Assessment at Discharge From the Intensive Care Unit in Patients Aged 75 Years and Older: a Feasibility Study

The number of patients aged over 75 continues to grow, and, according to INSEE, will represent almost 10% of the French population in 2021, an increase of 2.4 points since 2000. This demographic change is also observed in the intensive care units, where admitted patients aged over 80 represent now up to 10-20% of critical care admissions, depending on the facility. The admission of these patients remains controversial, with questions about the benefit to elderly patients, both in terms of in-hospital and distant survival, as well as induced morbidity or subsequent quality of life: functional status is impaired in up to two-thirds of survivors. The challenge of identifying the patients most able to withstand a stay is a major one. Indeed, a stay in intensive care represents a major stress for the organism, due to the acute condition associated with one or more organ failure(s). Bed rest, immobilization and the use of drugs are responsible for formidable complications in the elderly: muscle-wasting, loss of adaptation to physical effort, loss of autonomy, delirium and agitation, all of which have their own long-term impact. While many studies have looked at the prognostic factors on admission of these patients, and the selection of the patient with the greatest probability of surviving the intensive care unit (ICU), improving the outcome of patients who survive to the ICU stay remains a little-investigated subject. However, the impact of physical and psychological disturbances induced by these patients' stay in intensive care is major, and their detection and management could be elements of interest in improving the care of this population. However, the feasibility of carrying out such an assessment immediately after an ICU stay has yet to be evaluated. The aim of this study would be to evaluate the feasibility of a geriatric assessment at the end of the ICU stay (or within 7 days of discharge) and at 6 months. This study is a prospective, randomized, single-center, open-label interventional study.

Application of the sG8 Scale in Real-World Geriatric Oncology Patients

This study is a multicenter, prospective, observational study. The study included patients aged 65 and older with solid tumors requiring systemic anti-tumor therapy. All patients underwent screening using the sG8 scale before the start of treatment, followed by routine treatment based on a plan developed through clinician decision-making. The study did not intervene in any way with the patients' diagnosis and treatment, and relevant clinical data during the treatment process were recorded accurately for follow-up patients. Study data were obtained from the electronic medical record databases and hospital information systems of multiple centers, including Sichuan Cancer Hospital. Patient clinicopathological features, pathological diagnoses, clinical stages, previous treatment histories, as well as anti-tumor treatment regimens after patient enrollment, drug dosages per cycle, treatment start times, incidence and grades of adverse events (AEs), and tumor response were extracted and collected from the medical records. All data were entered, managed, quality-controlled, exported, and analyzed through a real-world data management platform (RWDMP).

Turkish Validation of the Geriatric Pain Measure - Short Form

This study aims to adapt, validate, and assess the reliability of the Geriatric Pain Measure - Short Form in Turkish. A total of 150 patients aged 65 years and older will complete the scale under the supervision of pain management and gerontology specialists. Reliability and validity will be evaluated using statistical analyses, including internal consistency, test-retest reliability, and correlation with validated pain and sleep scales. Ethical approval has been obtained, and all participants will provide informed consent.

A Geriatric Mobile Team for Nursing Home Residents: a Feasibility Pilot Study

Nursing home (NH) residents have complex healthcare needs. Barriers to collaboration hinder the delivery of high-quality care in nursing homes. To bridge the gap between hospital-based and NH-based care, various innovative approaches have been proposed, including geriatric mobile teams. In Belgium, geriatric expertise has long been confined to hospital settings. Until recently, no specific organization existed for outpatient geriatric assessment, particularly for NH residents. In April 2024, the National Institute for Health and Disability Insurance (INAMI) introduced a new reimbursement code for geriatric consultations in NHs, promoting the development of extramural geriatric activities. However, evidence on the effectiveness of mobile geriatric teams remains limited, particularly regarding hospitalization prevention. The geriatrics department of CHU UCL Namur is implementing a one-year pilot project involving a mobile team composed of a geriatrician and a nurse to conduct geriatric assessments in the three nursing homes. This non-randomized pilot project aims to establish a new standard of care for residents selected by their general practitioner, leveraging the new reimbursement code. The project is accompanied by a clinical study assessing the feasibility, effectiveness, and acceptability of this intervention. Prospectively collected data will also help define key indicators for a future large-scale study focused on cost-effectiveness.

Understanding the Preferences and Views of Older Adults on the Use of Geriatric and Objective Functional Assessments for Cancer Treatment Planning.

This Interventional clinical study aims to explore how receiving information about their health and physical abilities affects the treatment decisions of older adults. The study will look at whether sharing detailed assessments of their health and functional status helps older adults better understand their condition and make informed decisions about their care. The main question it aims to answer is if providing this information changes the treatment priorities of older adults, helping them focus on what matters most to them in their medical care.

Optimized Recovery After Trauma in Geriatric Patient

Currently, there is evidence that structured care within the healthcare system increases the conditions for good care and better recovery. We want to investigate whether a new care concept (gero-ERAT) that combines two variants of structured care can improve the recovery of elderly patients affected by a physical trauma. Our hope is that the project will reduce the complications, short care times, fewer re-admissions and that more patients can return to regular living, which reduces the suffering for the patient and his relatives. In addition to patient benefit, a successful outcome will also result in reduced costs for healthcare and society as a whole. The concept of care is based on an increased patient participation, which is in line with the values of the Västra Götaland region and the Sahlgrenska university hospital Through the PhD project, four studies will be published. A qualitative interview study to investigate patients' experiences of care and recovery after trauma. After that, a prospective cohort survey of two groups is carried out; conventional care and gero-ERAT. Data will begin to be collected in the control group and when the control group is full geroRATAT will be implemented in the care department and we then collect data in the intervention group. Based on collected data, we will publish two additional studies one with a focus on health economics as well as one focusing on care time and recovery based on age and harvest estimation.