Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Coherent navigation and support from a family-centred viewpoint throughout the cancer trajectory, despite the individual patient's affiliation to any department.

Department-specific coordination and answers to questions from a patient-centred viewpoint.

Nurse navigation

Current care coordination

Lise Fillion, PhD

Jens Søndergaard, PhD

Marianne K Thygesen, PhD

Niels Qvist, DMSc

In western countries, the number of cancer survivors increases, and current cancer care seems insufficient with both patients' experiences of lack of help in transitions and up to 60 % of the patients having psychological problems after treatment. Further, Denmark shall have new hospitals, where researchers and healthcare professionals are expected to merge tasks and reach a higher patient experienced quality of care, without additional costs, so a better way to provide cancer care, which benefits the patients and supports the ideas within the new hospitals in Denmark, is needed.

In a randomized controlled trial, the organizational structure of the healthcare system is challenged and the impact of a coherent nurse navigation practice compared to the currently existing department-specific care coordination is tested. The primary data are changes in patients' self-reported cancer-related self-efficacy from inclusion till one week after receipt of the information that they have reached the end of treatment, or in case of prolonged treatment, till not later than one year after inclusion.

Patients can participate if they are 18 years of age or older, speak and understand Danish, and have a proven lesion suspected of cancer in the colon or rectum after colonoscopy or sigmoidoscopy at the Danish endoscopy centers at Odense University Hospital (the cities: Nyborg, Svendborg and Odense) or at Slagelse Hospital. Furthermore, participants must not be mentally retarded, they must not suffer from a constant life-threatening disease, and they must not suffer from, or be in the diagnostic phase of, dementia or severe psychiatric disease.

Participants are allocated to support from nurse navigation or to current care coordination, and fill in four questionnaires during their cancer trajectory: 1) At inclusion, 2) Three days before treatment start, 3) One week after receipt of information about treatment end or not later than one year after inclusion, and 4) Six weeks after measure point 3. Data is analyzed using suitable statistical models.

With positive results, participants in nurse navigation are better helped during their cancer trajectory and have a better psychological start on the rest of their lives after cancer treatment. Focus will be on colon and rectum cancer care, but the results will be transferable to similar settings. Furthermore, positive results will support changes in the onset of rehabilitation initiatives.

The primary hypothesis in this study is:

Nurse navigation, as a specific, defined concept of coherent help through cancer trajectories, will prove superior to current care coordination with regard to patients' self-evaluated self-efficacy for cancer from inclusion to one week after receipt of information about treatment end or not later than one year after inclusion.

Allocation The randomization will be stratified by age and gender. The rational is that age and gender is differently associated with benefit by a given care.

Data collection Participants fill in questionnaires at four measurements, and supplements to sociodemographic information as well as information for an economic evaluation is collected from provider side.

The questionnaires for participants are available in paper and electronically, and participants are allowed to discuss the individual questions with a person whom they trust before filling in their answers. If a participant is blind or dyslexic and has no one to help them fill in the questionnaires, a trained study nurse will read out loud the questions and fill in the participant's answers, and eventually in this process, listen to the participant's pros and cons, acknowledge that they are heard, ask for an answer and read out loud the question again. All data are stored in Research Electronic Data Capture (RedCap).

Blinding The trial is not blinded but all participants are told, there is no favorite group. The statistician is blinded to randomization group and this blinding will be unveiled after the data is analyzed.

Statistics Data are analyzed following the modified intention-to-treat principle, which is carried out by a senior statistician in close collaboration with the research group. Usual descriptive statistics will be used to summarize baseline and subject characteristics. The analyses of the primary endpoint, i.e. change in self-evaluated self-efficacy for cancer from inclusion (measurement 1) to end of treatment (measurement 3), and the secondary outcomes are done using analysis of covariance of the measure at measurement 3 with randomization group as a factor and measure at measurement 1 as covariate. In secondary analyses for all endpoints (measurement 1-4), the change over time will be investigated by mixed effects repeated measures analysis with randomization group as factor and random effects for subjects. These analyses are repeated within the subgroup of all cancer patients and the subgroup of cancer patients treated with curative aim. In the subgroup analyses, the influence of relevant subject-level confounders such as age, disease-stage, treatment, etc. will be explored, and appropriate adjustment will be performed. An economic evaluation will be performed for each randomized group and compared.

Nurse Navigation Versus Current Care Coordination During Colorectal Cancer Trajectories

NaviCan. Navigation and Support to Cancer Patients - A Randomized Controlled Trial.

Qualitatively validated questions answered by participants

Patients experienced needs and degree of fulfilled support

European Organisation for Research and Treatment of Cancer Quality of life questionnaire with 30 questions (EORCT QLQ-c30).

University of Southern Denmark

Laval University

Slagelse Hospital

Region of Southern Denmark

Region Zealand

Danish Cancer Society

Odense Patient Data Explorative Network

Odense University Hospital

Associate professor

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Breast Neoplasms

Prostatic Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Lymphoma

Urinary Bladder Neoplasms

Ovarian Cancer

Ovarian Epithelial Cancer

Lymphosarcoma

Arm A "Standard oncological care": patients will be treated according to daily oncological practices as defined for each type of cancer, in the "Management protocol of Oncology" written and validated by a group of expert oncologists. The quality of life will be assessed every 3 months during the first year and at 18 months. The study's follow-up will last until 3 years after the enrollment of the last patient and data on vital status of the patient, weight, place of life and the status of the disease will be collected every 6 months.

Arm B "Geriatrician Intervention": patients will be treated according to the same "Management protocol of Oncology" than patients in the arm "Standard oncological care".

* Before the beginning of the medical treatment, a comprehensive geriatric assessment will be performed by the geriatrician and the nurse that will define a plan of geriatric management care, according to the "Management protocol of Geriatrics".
* The nurse, under the supervision of a geriatrician, will monitor implemented geriatric interventions. Phone follow-up will be performed every month for 6 months and at 9 months or during any change of situation according to a pre-established phone call plan. A full geriatric assessment by the geriatrician and the nurse will be performed at 6 and 12 months.

Arm B : The duration of the geriatric intervention will be 12 months. The quality of life will be assessed every 3 months during the first year and at 18 months. The study's follow-up will last until 3 years after the enrollment of the last patient and data on vital status of the patient, weight, place of life and the status of the disease will be collected every 6 months.

Geriatrician Intervention

Pierre-Louis SOUBEYRAN, PU-PH

Caroline LALET

Hervé CURE, PU-PH

Sophie ABADIE-LACOURTOISIE, MD

Kamel GHOMARI, MD

Jean-Frédéric BLANC, PU-PH

Jean-Briac PREVOST, MD

Jeannick MADELAINE, MD

Sophie HUMBLOT, MD

Hazem Georges HASWANI, MD

Isabelle CAUVIN, MD

Sylvie GERARD, MD

Jacques Olivier BAY, PU-PH

Xavier DURANDO, MD

Christophe TOURNIGAND, PU-PH

Christos CHOUAID, MD

Laure GAUTIER-FELIZOT, MD

Leila BENGRINE-LEFEVRE, MD

Nathalie GROSSAT, MD

Vanessa PANTE, MD

Christophe DESAUW, MD

Cécile FOURNEL-FEDERICO, MD

Denis PERE-VERGE, MD

Catherine TERRET, MD

Frédérique ROUSSEAU, MD

Jérôme DAUBA, MD

Fabienne PORTALES, MD

Cécile DELATTRE, MD

Claude EL KOURI, MD

Nadine HOUEDE, PU-PH

Thomas APARICIO, MD

Corinne DAGADA, MD

Claire FALANDRY, MD

Anne-Claire HARDY-BESSARD, MD

Patrick BOUCHAERT, MD

Riad BENRAMDANE, MD

Laetitia STEFANI, MD

Laurent CANY, MD

Delphine MOLLON, MD

Jean-Christophe EYMARD, MD

Thierry LAMY de la CHAPELLE, MD

Christophe PERRIN, MD

Pierre MICHEL, PU-PH

Anne MERCIER-BLAS

Stéphanie BORDENAVE, MD

Hervé DESCLOS, MD

Elisabeth CAROLA, MD

Jean-Emmanuel KURTZ, PU-PH

Loïc MOUREY, MD

Aurélien CARNOT, MD

Thierry LECOMTE, MD

Randomized trials have already demonstrated that geriatric intervention was able to improve survival in the general elderly population but only a few have been performed in cancer patients. At the end, these data are not sufficient to consider geriatric intervention as validated in this setting. Case Management, coordinated by a geriatrician and a trained nurse, could improve prognosis of elderly patients with cancer. This approach, can be integrated in daily oncology practice. This strategy will be compared to usual oncological management in a randomized phase III trial.

Patients will first be screened using the G8 screening tool. If the resulting score is altered (G8 \<= 14), patients will be included in the main study and randomized according to 2 modalities: Arm A / Usual care (treatment according to on-going regimens in oncology) or Arm B /Case management (assessment of the patient by the nurse and the geriatrician with interventions as prescribed by the geriatrician). The intervention will be considered effective if, at one year, compared to usual care there is a significant clinical improvement in overall survival (OS) without a significant deterioration or/and clinical improvement of at least one of the targeted quality of life (QoL) scores, without significant clinical deterioration in at least one of the targeted QoL scores and without significant difference in OS in favor of usual care.

If the resulting score is normal (G8 \> 14), patients will be treated according to their physician-in-charge opinion. A minimal set of data will be collected (age, sex, tumor type, disease stage, performance status (PS), creatinine clearance, albumin and C-Reactive Protein (CRP) levels mainly) to allow for the characterization of the population in order to compare our results to those of other published series.

Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE)

Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)

Ministry of Health, France

Institut Bergonié

Heart and Blood Diseases

Heart Diseases

Adrenal Cortex Diseases

Adrenal Gland Diseases

Endocrine System Diseases

Case management

Russell E Hilliard, PhD, LCSW

Eliot Fishman, PhD

Barbara Paris, MD

The purpose of this study is to evaluate whether or not case management by a social worker and nurse can decrease the number of emergency room visits, increase the number of primary care doctor visits, and increase quality of life of people in a Medicaid managed care plan.

This study will assign participants based on Zip Code to one of two conditions: control and experimental. In the control group, participants will receive telephonic assessments at baseline, three months, and six months. These assessments will be conducted by a member of the Medical Center's Department of Geriatrics under the supervision of the Principal Investigator. Participants in the experimental group will receive medical case management provided by a nurse and social worker in the homecare setting including an in-home assessment. Assessments will be conducted at baseline, three months, and six months during routine homecare visits. Dependent variables being measured include: access to primary care physicians, emergent hospitalizations/admissions, articulation of advance directives, and quality of life. Data will be collected through the participants' medical claims and records to analyze the number of emergent hospitalizations/admissions, documentation of advance directives, and number of visits to primary care physicians. To measure participants' quality of life, the Depression Self-Rating Scale and the Clinical Anxiety Scale will be utilized. Data will be compared between and within the groups via statistical analyses. The researcher will conduct pre-post comparisons of utilization and other database-derived outcomes for both groups, comparing the 12 months prior to and up to 20 months following enrollment.

The Effects of Case Management in a Medicaid Managed Care Plan

Metropolitan Jewish Health System

Colonic Neoplasms

Rectal Neoplasms

Control group patients will receive usual medical plus usual supportive treatment.

Intervention group patients are offered the support of a nurse case manager throughout their course of treatment.

Nurse case management

Christian N Wulff, MD

Introduction: Case management (CM) has been proposed as a method for optimizing the course of treatment for complicated cancer patients. However evidence of the effect of CM is limited and methodologically rigorous research is needed.

Aim: To analyze effects of Nurse CM in complicated cancer care.

Methods: The study is designed as a two-arm randomized controlled trial (RCT) including approximately 280 colorectal cancer patients.

Intervention group patients will be offered usual medical treatment plus supportive intervention from a case manager. Control group patients will receive usual medical and supportive treatment.

The intervention: Case managers are registered nurses and possess thorough knowledge of cancer treatment and pathways. Core intervention elements: Planned and ad hoc personal and telephone contacts, surveillance of care pathways, coordination and dissemination of care plan (including transfer of patient-specific information to other departments and general practice).

Primary outcomes: Patient evaluations of care pathways and "Quality of Life" (questionnaires).

Secondary outcomes: Use of health care services and care process measures (The National Health Insurance Service Registry and The National Patient Registry; and GPs' evaluations of continuity of care (questionnaire).

Schedule:

* "Case management used to optimize cancer care pathways: A systematic Review" has been published in BMC Health Services Research.
* The CM manual has been written. Questionnaires are under development and pilot testing.
* Two case managers have been appointed 1. January 2009.
* After training and pilot testing of the intervention the RCT will begin in March 2009. Inclusion period is 12 months.

The Effect of Case Management in Complex Cancer Pathways

Research Unit for General Practice, Aarhus University

The Research Council for Health and Disease, Denmark

Novo Nordisk A/S

Kvalitets- og efteruddannelsesudvalget for Region Midtjylland

University of Aarhus

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

The patients with new-diagnosed lung cancer and accepting case management

the patients with non-new-diagnosed lung cancer and with accepting case management

The patients with new-diagnosed lung cancer in the period of one year ago and without accepting case management

case management group will accept the case manager's service; the control group will just accept the routine care

case management

Ming-Ying Hong, RN, Master

The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center.

Purpose: The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center. The outcome variables include of percentages of patients accepted treatment in our medical center, average lengths of stay, unplanned re-admission rate, average admission times of emergency department per year, percentages of patients rejecting treatment, completing rate of treatment, withdrawing rate of treatment, improving rate of patients' treatment compliance, patients' satisfaction with healthcare, and staffs' satisfaction with case management.

Methods: The study will employ a quasi-experimental research design. The patients with new-diagnosed lung cancer and accepting case management will be assigned to the experimental group； The patients with new-diagnosed lung cancer in the period of one year ago and without accepting case management will be assigned to the control group；The third group is the patients with non-new-diagnosed lung cancer and with accepting case management. The staffs are the doctors within the lung cancer medical team.

The lung cancer case management database, patients' satisfaction questionnaire, and staffs' satisfaction questionnaire will be used to measure the effectiveness. Statistical software SPSS for Windows version 17.0 will be used to analyze the data.

Expected results: The research outcome will to confirm the impact of case management on the lung cancer patients and could be the reference data for future cancer case management model.

Effectiveness of Nursing Case Management for Lung Cancer Patients

The Effectiveness of Nursing Case Management for Lung Cancer Patients in a Taiwan Medical Center

We reviewed the chart and lung cancer case management database to collect the patients' healthy outcome. The outcome variables include of percentages of patients accepted treatment in our medical center, average lengths of stay, unplanned re-admission rate, average admission times of emergency department per year, percentages of patients rejecting treatment, completing rate of treatment, withdrawing rate of treatment, improving rate of patients' treatment compliance.

National Taiwan University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nurse Navigation Versus Current Care Coordination During Colorectal Cancer Trajectories	NCT03281447	Self Efficacy Continuity of C... Quality of Life Colorectal Neop... Case Management	Nurse navigatio... Current care co...	18 Years -	Odense University Hospital
Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE)	NCT02704832	Breast Cancer Colorectal Canc... Lung Cancer Prostate Cancer Bladder Cancer Ovarian Cancer Lymphoma	Geriatrician In...	70 Years -	Institut Bergonié
The Effects of Case Management in a Medicaid Managed Care Plan	NCT00385879	Neoplasms Heart Diseases Adrenal Cortex ...	Case management	18 Years -	Metropolitan Jewish Health System
The Effect of Case Management in Complex Cancer Pathways	NCT00845247	Colonic Neoplas... Rectal Neoplasm...	Nurse case mana...	-	University of Aarhus
Effectiveness of Nursing Case Management for Lung Cancer Patients	NCT02070497	Lung Cancer	case management	20 Years -	National Taiwan University Hospital

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