Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.

Geriatric intervention

Torgeir B Wyller, Dr.med

This is a randomized, controlled trial on frail elderly patients (aged 65+) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized perioperative intervention.

The main aim of the study is to see if the number of postoperative complications in this group can be reduced by a perioperative geriatric intervention. A study of inflammation markers in serum will also be performed, with focus on identifying potential biological frailty markers.

Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial.

Number of patients in need of any operation within thirty days after the operation for colorectal cancer.

Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.

Number of patients living at home, with or without formal help, and number of patients living in nursing homes 3 months after surgery.

Norwegian Cancer Society

University Hospital, Akershus

Oslo University Hospital

Professor

interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up

personalized support program

GAXATTE Cédric, MD

Elderly cancer patients need more help from their relatives and for longer than young adults.

Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.

Scientific context Elderly cancer patients need more help from their relatives and for longer than young adults. The person who takes primary responsibility for someone who cannot care fully for themselves is called the primary caregiver.

A recent personal study concerning elderly cancer patients caregivers show that most caregivers reported high or moderate levels of psychological distress, with an impact on their own health status.

In addition, family caregivers often report deficits in information about the disease, in training and skills related to their patients' care, and a lack of assistance from healthcare professionals.

The ability of the primary caregiver to meet the medical, material and emotional needs of the patient depends on their own resources (psychological, physical, intellectual, physical, financial) and on the diversity of their social network, but it also depends on the quality of the personalized support program (including information and training) that has been established for them.

Research hypotheses

Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.

Intervention description

Prospective, interventional, randomized trial, with 118 patients in each group:

* an experimental interventional arm including an interview of the primary caregivers to identify their needs and expectations, the implementation of a "personalized support program", including telephone follow-up
* A control arm corresponding to the standard care. Caregiver aid is usually proposed when accompanying a sick relative in consultation or hospitalization.

All the "couples patient / caregiver' will benefit initially from:

1. a comprehensive geriatric assessment (elderly patients with cancer)
2. an assessment of caregiver burden by the Zarit burden interview (ZBI)
3. an assessment of subjective well-being
4. an individual assessment of the precariousness and health inequalities based on the score EPICES (Evaluation of precariousness and health inequalities in the health Centers)

Randomization will be stratified according to:

* living in the same household or not
* score of initial Zarit Burden Interview

Intervention Stage 1: A semi-structured interview centered on the caregiver's needs (COAT tool) Stage 2: guided questionnaires to assess the psychosocial situation of caregivers Stage 3: implementation of a multi-component PSP (information, counseling, listening time, training to help overcome their difficulties as a caregiver, planning for future care) Stage 4: at least one monthly phone interview Stage 5: 6 months follow up on the psychosocial characteristics of caregivers

Expected results in public health Our study will help to better define the way to take better account of the needs of the helper / helped couple, and reinforce the role of the coordinating nurse in the care pathways.

If our hypotheses can confirmed that there is a link between the caregivers needs and the social determinants of health and that the intervention has a positive impact on the caregivers burden and stress, it will suggest that this intervention not only acts favorably on social inequalities in health, but it can help reduce health care costs, as the caregiver exhaustion increases the risk of health expenditure (drug consumption, hospitalization of the patient and of the caregiver).

The Needs and Burden of Family Caregivers of Older Adults With Cancer

The Needs and Burden of Family Caregivers of Older Adults With Cancer and Their Social Determinants

Caregiver Reaction Assessment (CRA) Carers' Assessment of Managing Index (CAMI) Inventory of social support (ISSB) Hospital Anxiety and Depression Scale (HADS) Cognitive Inventory of Subjective Distress (CISD) Subjective well-being scale (BES)

Centre Oscar Lambret

University of Lille Nord de France

National Cancer Institute, France

University Hospital, Lille

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Nervous System Diseases

Behaviors and Mental Disorders

Immune System Diseases

Rare Diseases

Heart Failure

Peripheral Arterial Disease

Peripheral Vascular Diseases

Vascular Diseases

Diabetes Mellitus

Lung Diseases

Leukemia

Renal Insufficiency, Chronic

Renal Insufficiency

Dementia

Leukemia, Lymphocytic, Chronic, B-Cell

Diabetes Complications

Hepatic Insufficiency

Liver Failure

Leukemia, Lymphoid

Liver Diseases

End Stage Liver Disease

Heart Diseases

Respiratory Tract Diseases

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Atherosclerosis

Arteriosclerosis

Arterial Occlusive Diseases

Chronic Disease

Disease Attributes

Endocrine System Diseases

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

The intervention has 4 steps: use electronic medical record (EHR) to identify seriously ill, hospitalized patients with no documentation of a goals-of-care (GOC) discussion during their current admission; the enrolled patient or his/her surrogate completes a survey assessing preferences for discussions about GOC, barriers to having such discussions, and current GOC which is used to create a "Jumpstart" form designed to prompt and guide a GOC discussion between the patient or surrogate and the clinicians caring for the patient; use natural language processing/machine learning (NLP/ML) approach to identify GOC discussions or advance directives in the EHR that occurred prior to admission and include this information on the Jumpstart form; and, deliver the Jumpstart form to the primary clinician team. The patient or surrogate is also provided with a version of the form.

Jumpstart Intervention

J. Randall Curtis, MD, MPH

This two-year pilot study will test whether a one-page "Jumpstart Form" will affect goals-of-care discussions in the hospital. This form will be provided to clinicians and will include patient-specific information about preferences for goals-of-care communication and for care, as well as tips to improve this communication. Jumpstart forms will also be provided to patients or, if they are unable to communicate, their surrogates/family members. The information on the form will be obtained from questionnaires. The form is tailored to help patients and surrogates talk with clinicians about goals of care. This study is based on a successful application of Jumpstart Form in the outpatient clinic setting.

Project to Improve Communication About Serious Illness - Pilot Study

Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication

Presence or absence of documentation of goals of care discussions in the patient's electronic health record during the current hospitalization

University of Washington

Professor, Department of Medicine, SOM: Department of Medicine: Pulmonary, Critical Care and Sleep Medicine

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.

The ERAS group patients were treated according to the ERAS pathway.

Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.

Multimodal prehabilitation program

The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.

ERAS protocol

Yanbing Zhou, MD

Yuqi Sun, MD

The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG). The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.

Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer

Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer: A Multicenter Randomized Controlled Trial

Major postoperative complications of patients with Gastrointestinal malignancy included gastrointestinal complication, surgical site complication, respiratory complication, cardiovascular complication, thromboembolic complication, urinary complication and other complications. The severity of complications was recorded and classified according to Clavien-Dindo classification score.

The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardio-pulmonary function.

QoL comprises patient-reported outcomes (PRO) of physical symptoms and psychosocial health status. Quality of Life Questionnaire (QLQ) C30 is sensitive tool for measuring individual performance status. Each index score ranges from 1 to 4, with higher scores indicating higher risk.

Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations

Postoperative pain severity, postoperative delirium severity and occurrence, first exhaust and defecation, ureteral catheter removal, abdominal drainage tubes removal, postoperative hospital stay, hospitalization costs, 30-day all-cause mortality and 30-day hospital readmission rate.

3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.

Shandong Provincial Hospital

Qilu Hospital of Shandong University

Qianfoshan Hospital

Yantai Yuhuangding Hospital

Jining First People's Hospital

Weifang Medical University

Weifang People's Hospital

Dongying People's Hospital

Weihai Municipal Hospital

Weihai Central Hospital

Rizhao People's Hospital

Liaocheng People's Hospital

The Affiliated Hospital of Qingdao University

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Cetuximab

Leucovorin

Fluorouracil

Levoleucovorin

Folic Acid

Mitogens

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

500 mg/m2 on day 1, Every 14 days Intravenously

Every 2 weeks, 400 mg/m2 on day 1; 2400 mg/m2 from day 1 to day 3, intravenously

5-fluorouracil

Every 2 weeks, Racemic leucovorin 200 mg/m2 or l-leucovorin 100 mg/m2 on day 1, intravenously

leucovorin

Marc Peeters, MD, PhD

Ulrich Wedding, MD

OBJECTIVE: The principal objective of the trial is to evaluate whether the addition of cetuximab associated with 5-fluorouracil in elderly patients with KRAS wild type advanced colorectal cancer (CRC) prolongs Progression Free Survival, compared with 5-fluorouracil alone.

The primary efficacy analyses will be performed on the Intention-to-treat population.

The safety analyses will be performed on the Safety population.

* Median PFS and OS in each treatment arm with its 95% CI, estimated by the Kaplan-Meier technique
* Response rates by treatment arm with their exact 95% CI
* IADL sum score, G8 sum score and social situation by treatment arm at baseline and at each timepoint of assessment
* QoL scores from the EORTC QLQ-C30 and QLQ-ELD14 modules by treatment arm at baseline and at each timepoint of assessment
* Safety data by treatment arm in the Safety population. Worst toxicity grade over all cycles according to the CTCAE criteria version 4.0 by treatment arm.
* Pharmaco-economics evaluation

Summary of proposed Phase II trial characteristics:

1. Total number of randomized patients: 150.
2. Total number of events at phase II analysis for primary endpoint: 110.
3. Total number of patients screened over the phase II: 250.
4. Total number of patients treated with cetuximab for the Phase II study: 75.
5. Maximum study duration: 19 months.

In the present study, HRQoL is an important secondary endpoint. The objective of the HRQoL data collection in this Phase II trial is to assess the impact of the addition of cetuximab on patients' HRQoL during treatment.

The hypothesis is that there will be no difference in patients' HRQoL between both treatment arms during treatment. The HRQoL domains (from the EORTC QLQ-C30 module) which are expected to be affected by treatment (to the same extent in both arms) are Global health status, Fatigue, Pain and Stool habits.

Colorectal Cancer (CRC) Cetuximab Elderly Frail

Treatment of Patients With KRAS Wild Type Advanced Colorectal Cancer (CRC) With 5-Fluorouracil (5-FU) or 5- FU Plus an Epidermal Growth Factor Receptor (EGFR) Inhibitor (Cetuximab) Based on a Comprehensive Geriatric Assessment (CGA).

Progression will be defined according to the "RECIST V1.1"

Adverse events will be graded according to the "Common Terminology Criteria for Adverse events" CTCAE,version 4.0.

Merck KGaA, Darmstadt, Germany

European Organisation for Research and Treatment of Cancer - EORTC

Postoperative Complications

Other Dietary Supplements

Whey Protein

Immediately after randomization and until surgery, patients in this arm will:

1. - Receive a personalized physical exercise program
2. - Receive nutritional counselling with Whey protein isolate powder
3. - Receive relaxation techniques

Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patients in the other arm but to be started after surgery.

Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.

Physical Exercise Program

Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Powder (Immunocal) is provided.

Immunocal1.5g/kg PO (by mouth) per day separated in 2 daily doses

Whey Protein Isolate Powder

Relaxation techniques consisting of breathing exercises and using a relaxation CD.

Relaxation Techniques

Franco Carli, MD, MPhil

The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.

Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer

Factoring the cost of the program versus possible savings related to other primary and secondary outcomes

Using the Hospital Anxiety Depression Scale (HADS)

Using the Short Form Health Survey (SF-36)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer	NCT01321658	Colorectal Neop...	Geriatric inter...	65 Years -	Oslo University Hospital
The Needs and Burden of Family Caregivers of Older Adults With Cancer	NCT02285296	Oncologic Disor... Tumor	personalized su...	18 Years -	University Hospital, Lille
The Needs and Burden of Family Caregivers of Older Adults With Cancer	NCT02285296	Oncologic Disor... Tumor	personalized su...	18 Years -	University Hospital, Lille
Project to Improve Communication About Serious Illness - Pilot Study	NCT03746392	Malignant Neopl... Leukemia, Lymph... Lung Disease Ch... Congestive Hear... Liver Failures,... Renal Insuffici... Dementia Diabetes Compli... Peripheral Vasc... Frail Elderly	Jumpstart Inter...	18 Years -	University of Washington
Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer	NCT05352802	Stomach Neoplas... Frail Elderly	Multimodal preh... ERAS protocol	65 Years - 85 Years	The Affiliated Hospital of Qingdao University
Colorectal Cancer (CRC) Cetuximab Elderly Frail	NCT01522612	Colorectal Canc...	Cetuximab 5-fluorouracil leucovorin	70 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Project to Improve Communication About Serious Illness - Pilot Study	NCT03746392	Malignant Neopl... Leukemia, Lymph... Lung Disease Ch... Congestive Hear... Liver Failures,... Renal Insuffici... Dementia Diabetes Compli... Peripheral Vasc... Frail Elderly	Jumpstart Inter...	18 Years -	University of Washington
Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer	NCT02502760	Colorectal Neop...	Physical Exerci... Whey Protein Is... Relaxation Tech...	-	McGill University Health Centre/Research Institute of the McGill University Health Centre

Spots Global Cancer Trial Database for frail elderly