Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Frailty

All outpatients, age 70 years or more, with solid malignancies, referred to the Department of Oncology at Odense University Hospital for 1st line antineoplastic treatment or information,

The G8 is an eight-item screening tool, developed for older cancer patients. The G8 score ranges from 0 (heavily impaired) to 17 (not at all impaired), with a cut-off for potential frailty of ≤14.

Geriatric 8

The mG8 is a modified version of the Geriatric 8 screening tool, consisting of 6-items. The mG8 score ranges from 0 (not at all impaired) to 35 (heavily impaired), with a cut-off for potential frailty at ≥6.

modified Geriatric 8

30 second chair stand test

Handgrip Strength Test

Marianne Ewertz, MD, DMSc

Jesper Ryg, MD, PhD

Cecilia M Lund, MD, PhD

Trine L Jørgensen, MD, PhD

Per Pfieffer, MD, PhD

Henrik J Ditzel, MD, DMSc

Older patients with cancer constitute a heterogeneous group with varying comorbidity; therefore, geriatric assessment with initial screening is recommended. The Geriatric 8 (G8) has been established as a promising screening tool. Currently, there are no guidelines for oncogeriatric screening in older cancer patients in Denmark. We hypothesize that by screening persons age 70 years or more with newly diagnosed cancer, with the G8, we can assess the prognostic value and identify a subgroup of patients who will benefit from a CGA.

Aims:

* Determine whether Danish cancer patients, with a G8 score of ≤14, experience poorer quality of life (QoL), receive less recommended standard cancer treatment, experience more treatment-related toxicity, stop treatment earlier, and experience shorter survival than patients with a G8 score \>14.
* Ascertain whether the standard G8 cut-off score of ≤14 is the most relevant cut-off score, with respect to treatment adherence, treatment-related toxicity, QoL, and survival, when focusing on the older Danish cancer patient population.
* Establish whether the performance and prognostic value of the G8 can be strengthened through the addition of a functional measure, the 30-second chair stand test (30-CST), and/ or the handgrip strength test (HGST).
* Evaluate the prognostic value of the modified Geriatric 8 (mG8)

Methods:

A prospective, descriptive study of all outpatients with newly diagnosed solid tumors at the Department of Oncology, Odense University Hospital, age 70 years or more. Patients will be screened with the G8, mG8, 30-CST, HGST, and QoL questionnaires at baseline with subsequent one-year follow-up, to determine the prognostic value of the G8 and the mG8. An initial two-month pilot study will help determine inclusion rates and highlight necessary practical adjustments to ensure optimal study participation. Baseline characteristics will be compared with descriptive statistics. Our primary endpoint; Global Health status/ QoL (EORTC QLQ-C30 \& QLQ-ELD14), and secondary endpoints; treatment adherence, and treatment-related toxicity, will be assessed using logistical regression; while secondary endpoints; overall survival, cancer-specific survival, will be assessed using the Kaplan Meier analysis and Cox proportional hazard models. Post hoc diagnostic performance analysis will be conducted to determine the optimal G8 cut-off and whether functional measures (30-CST and HGST) can enhance screening accuracy.

Geriatric Oncology Screening of Older Patients With Solid Cancers

Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers: A Prospective G8 Study

Global health status will be described using EORTC QLQ-C30

HRQoL is measured by EORTC QLQ-ELD14 (ELderly Cancer Patients Module)

Overall Survival is measured from Geriatric 8 screening to time of death

Cancer-specific Survival is measured from Geriatric 8 screening to time of death in patients with residual cancer

Deviation from initial oncologic treatment plan with the registration of dose reductions, with the given dose measured as a percentage of the planned dose.

Deviation from initial oncologic treatment plan with the registration of dose delays, measured in days.

Deviation from initial oncologic treatment plan with the registration of discontinuation of treatment, measured as the number of given cycles divided by the number of planned cycles.

Performance analysis will be conducted using patients allocated to Comprehensive Geriatric Assessment (CGA), where an abnormal CGA will be defined as \>1 abnormal domain, in accordance with the Danish version of the Geriatric Core Dataset (G-Code).

Academy of Geriatric Cancer Research

Danish Cancer Society

University of Southern Denmark

Odense University Hospital

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Lung Neoplasms

Malnutrition

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Nutrition Disorders

Nutritional Risk Screening-2002

Nutritional Risk Index

Mini Nutritional Assessment

Glasgow Prognostic Score

Prognostic Nutritional Index

Anthropometric measurements

Handgrip strength test

Seda Eğilmez

Nermin Kelebek Girgin

Seda Eğilmez, 1

Nermin Kelebek Girgin, 2

Malnutrition is common in patients with lung cancer. In patients with malnutrition risk, the risk of complications is high both in the perioperative, early and late postoperative periods. Malnutrition is an independent risk factor for length of hospital stay and cost in these patients. Patients with lung cancer may have many morbidities in postoperative period, especially problems with wound healing. Therefore, assessment of the nutritional status of patients with lung cancer should begin at the diagnosis stage.

In patients with lung cancer scheduled for lobectomy, anthropometric measurements will be measured and the results of laboratory tests(albumin, prealbumin, creatinine, total lymphocyte count, C reactive protein), Nutritional Risk Screening-2002, Nutritional Risk Index, Mini Nutritional Assessment, Glasgow Prognostic Score, Prognostic Nutritional Index and neoadjuvant chemotherapy or not will be recorded in 72 hours before surgery. In addition, demographic information of the patients (name, surname, identification number, age, comorbidity, American Society of Anesthesiologists score) will be recorded. After the information is given to the patients, their written and verbal consent will be obtained.

In the operating room, routine monitoring (electrocardiography, invasive blood pressure measurement, arterial blood gas monitoring, peripheral oxygen saturation, end-tidal carbon dioxide measurement by capnography) will be applied to the patients in accordance with the standard protocol for elective lobectomy surgery.

Hemodynamic changes (eg. dysrhythmia, hypotension, hypertension, hemorrhage), metabolic status (pH, bicarbonate, base excess), lactate, glucose level in blood gas evaluation and intraoperative complications will be recorded during the intraoperative period.

In the postoperative period, length of stay in the intensive care unit, length of hospital stay, early complications (eg. dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak), time to start oral intake and transition to adequate oral intake will be recorded in the one-month postoperative period.

Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy

dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak

Length of stay in the intensive care unit

dysrhythmia, hypotension, hypertension, hemorrhage

time to start oral intake and transition to adequate oral intake

bicarbonate level in arterial blood gas evaluation

base excess in arterial blood gas evaluation

lactate level in arterial blood gas evaluation

glucose level in arterial blood gas evaluation

Turkish Society of Anesthesiology and Reanimation

Nervous System Diseases

Digestive System Diseases

Sarcopenia

Gastrointestinal Neoplasms

Digestive System Neoplasms

Muscular Atrophy

Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Gastrointestinal Diseases

handgrip strength test

chemotherapy

Sarcopenia is defined as a loss in skeletal muscle mass and function (strength and/or performance). There is a high prevalence in elderly and in patients with cancer. Several mechanisms are known to explain sarcopenia (inflammation, neurodegenerative process, hormonal disorders, lack of exercise, malnutrition). The consequences were analysed in several studies where sarcopenia appeared to be an independent factor of mortality, and associated with cancer-related fatigue, nosocomial infections, cardio-vascular diseases, and chemotherapy toxicities.

Diagnosis is based on the measure of the muscle mass performing an abdominal computed-tomography (CT) scan, and on the measure of the muscle strength using the handgrip test with a "Jamar®" hydraulic hand dynamometer. CT scan is more invasive and less easy to reach than handgrip test. This test is used to be performing in elderly but not in cancer patients having chemotherapy. Present prospective study explored the feasibility of systematic handgrip strength testing and short-term changes in muscle strength in digestive cancer patients treated by chemotherapy.

Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy

CHU de Reims

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Axicabtagene ciloleucel

The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles.

The Wechsler Test of Adult Reading (WTAR) is a neuropsychological assessment tool used to provide a measure of Intellectual function. Participants are presented with 50 irregularly spelled words and prompted to pronounce each; the irregular grapheme-to-phoneme translations (such as the "gh" in the word tough) in the prompts make it difficult to pronounce without having previously learned the word. A high WTAR score is correlated with higher general intelligence as measured by the Wechsler intelligence scales.

Neuropsychological Assessment - Wechsler Test of Adult Reading (WTAR)

The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) consists of twelve subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory).

Neuropsychological Assessment - Repeatable Battery for the Assessment of Status (RBANS)

The Color Trails test measures sustained attention and sequencing. Numbered circles are printed with vivid pink or yellow backgrounds that are perceptible to color-blind individuals. Participants rapidly connect circles numbered 1-25 in sequence and rapidly connect numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.

Neuropsychological Assessment - Color Trails

The Stroop Color and Word Test is based on the observation that individuals can read words much faster than they can identify and name colors. The test-taker reads color words or names ink colors from different pages as quickly as possible within a time limit. The test yields three scores based on the number of items completed on each of the three stimulus sheets. An Interference score is useful in determining the individual's cognitive flexibility, creativity, and reaction to cognitive pressures.

Neuropsychological Assessment -Stroop Color and Word Test

The PROMIS-29 questionnaire assesses each of 7 domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities). A higher score equals more of the concept being measured.

Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Questionnaire

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-3) and the add-on EORTC QLQ Non-Hodgkin's Lymphoma (EORTC QLQ-NHL-HG29) module. All scales range from 0-100, a high scale score represents a higher response level. For example, a high functional score represents a high level of functioning.

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire

The EQ-5D-5L questionnaire is a self assessed quality of life questionnaire. The scale measures quality of life on a 5 component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.

Quality of Life (EQ-5D-5L) Questionnaire

The PROMIS measures function, symptoms, behavior and feelings.

PROMIS Cognitive Function 4a Questionnaire

The COST is a questionnaire made up of 11 statements around topics including costs, concerns and resources and is designed to measure financial toxicity. The user answers questions about their concern over finances numbered from 0-4, with 0 being not at all and 4 being very much.

Comprehensive Score for Financial Toxicity (COST) measure

Heather Jim, PhD

Fred Locke, MD

The purpose of the study is to assess self-reported side effects and neurocognitive (brain, mood and thinking) functioning among patients treated with commercial axi-cel therapy.

Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes

Memory changes will be assessed with the Repeatable Battery for the Assessment of Status (RBANS) which assesses immediate memory (list learning and story memory), visuospatial/constructional abilities (figure copy and line orientation), language (picture naming and semantic fluency), attention (digit span and coding), and delayed memory (list recall, list recognition, story recall, and figure recall) domains. Both total scores and scaled/percentile group scores are calculated for each test and total scores are derived for each cognitive domain. Total scores for each cognitive domain are then summed together to create a total scale score.

Attention and concentration are will be assessed using Part 1 of the Color Trails Test (CTT-1) and the Connors Continuous Performance Test Third Edition (CPT3). The CTT is an analogue of the original Trail Making Test without significant influence of language. CTT-1 consists of a page with scattered circles numbered from 1 to 25.

Even numbered circles are colored yellow and odd-numbered ones are colored pink.

Respondents are instructed to connect the circles in consecutive numeric order with a continuous line as quickly as possible. The alternating colors are not mentioned in the instructions. A total score is determined by recording the number of seconds required to complete the task.

Executive Functioning will be assessed using Part 2 of the Color Trails Test (CTT-2) and the Stroop Color and Word Test. The CTT-2 consists of a page containing 25 pink circles and 25 yellow circles numbered 1 - 50. Participants connect the circles in consecutive order while alternating colors (1 pink, 2 yellow, 3 pink, etc.). A total score is determined by recording the number of seconds required to complete the task. The Stroop Color and Word Test consists of three tasks, a Word Task, a Color Task, and a Color-Word Task. In the Word Task, participants are required to read a list of color words printed in black ink. In the Color Task, participants are presented with rows of X's printed in colored ink, and asked to name the color of each set of X's. In the Color-Word Task, color names are presented in different color ink, and participants are asked to identify the color ink in which each color name is printed. The Stroop yields a score on each task as well as an interference score.

The hand grip test assesses hand and forearm strength using a hand dynamometer. Participants without a history of arthritis or hand surgery will be asked to squeeze the dynamometer twice using each hand for a total of two bilateral measurements.

Change in patient-reported outcomes measured using the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Questionnaire, which is a 29 item questionnaire assessing aspects of quality of life in the past 7 days on 7 4-item subscales: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance and ability to participate in social activities. Patients rate functioning on a 5-point Likert scale. Higher scores indicate more of the attribute being measured.

Change in patient-reported outcomes measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) which assess quality of life and symptomatology in the past week using a 4 point Likert scale (1=not at all, 4=very much). Higher scores on the quality of life subscales indicate better quality of life. Higher scores on the symptom items and subscales indicate greater symptomatology.

Change in patient-reported outcomes measured using the Quality of Life (EQ-5D-5L) Questionnaire, which is a 5-item measure that can be used to describe and value current overall health consisting of 5 items assessing mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participant chooses from 1 of 5 categories (e.g.; "I have no problems washing or dressing myself" to "I am unable to wash or dress myself"). Higher scores indicate worse overall health.

Change in patient-reported outcomes measured using the Everyday Cognition Questionnaire (ECog) assess the subjective evaluation of cognitive function in routine daily activities. 40 items yield scores for 7 domains (Everyday Memory, Language, Visuospatial Abilities, Planning, Organization, and Divided Attention) and a total score. Items evaluate current cognition compared to 10 years ago; responses are evaluated on a 5-point Likert scale ("better or no change" to "consistently much worse") Higher scores indicate worse subjective cognitive function.

Change in patient-reported outcomes measured using the PROMIS Cognitive Function 4a Questionnaire asks about cognition in the past 7 days using a 5-point Likert scale (1=very often, several times a day; 5=never). Higher scores indicate better overall perceived cognition.

Change in patient-reported outcomes measured using the Comprehensive Score for Financial Toxicity (COST). Financial toxicity is assessed using an 11-item patient-reported measure of financial stress used in cancer patients. The COST yields a total score with higher scores indicating less financial toxicity in the past week.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Geriatric Oncology Screening of Older Patients With Solid Cancers	NCT04644874	Solid Carcinoma Frailty Age Geriatrics Screening Cancer	Geriatric 8 modified Geriat... 30 second chair... Handgrip Streng...	70 Years -	Odense University Hospital
Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy	NCT05417672	Lung Cancer Malnutrition Nutritional Def...	Nutritional Ris... Nutritional Ris... Mini Nutritiona... Glasgow Prognos... Prognostic Nutr... Anthropometric ... Handgrip streng...	18 Years -	Turkish Society of Anesthesiology and Reanimation
Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy	NCT05417672	Lung Cancer Malnutrition Nutritional Def...	Nutritional Ris... Nutritional Ris... Mini Nutritiona... Glasgow Prognos... Prognostic Nutr... Anthropometric ... Handgrip streng...	18 Years -	Turkish Society of Anesthesiology and Reanimation
Geriatric Oncology Screening of Older Patients With Solid Cancers	NCT04644874	Solid Carcinoma Frailty Age Geriatrics Screening Cancer	Geriatric 8 modified Geriat... 30 second chair... Handgrip Streng...	70 Years -	Odense University Hospital
Feasibility of Systematic Handgrip Strength (HGS) Testing and Short-term Changes in Muscle Strength in Digestive Cancer Patients Treated by Chemotherapy	NCT02797197	Handgrip Streng... Sarcopenia Digestive Cance... Muscle Strength Chemotherapy	handgrip streng... chemotherapy	18 Years -	CHU de Reims
Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes	NCT04319237	Diffuse Large B... Transformed Lym...	Handgrip streng... Neuropsychologi... Neuropsychologi... Neuropsychologi... Neuropsychologi... Patient Reporte... European Organi... Quality of Life... PROMIS Cognitiv... Comprehensive S...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy	NCT05417672	Lung Cancer Malnutrition Nutritional Def...	Nutritional Ris... Nutritional Ris... Mini Nutritiona... Glasgow Prognos... Prognostic Nutr... Anthropometric ... Handgrip streng...	18 Years -	Turkish Society of Anesthesiology and Reanimation

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