Behaviors and Mental Disorders

All Conditions

Quality of Life

specific preoperative education program realised by a specialized stoma-therapist containing individualized information on material maintenance, hygiene, nutrition, complications, activities of daily life and occupation

standard preoperative education program administered by a surgeon containing information on surgery, outcome, risks and alternatives

Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes

Education program

Stefan Berkhoff, MD

Stefan Berkhoff, Doctor

Ulrike Wauer, MD

Beate Mantz

Patients with colorectal cancer prior to stoma surgery are randomized to different preoperative education programs: (a) specific preoperative education, (b) standard preoperative education. Outcome measures are quality of life, period of hospitalization and complication rates.

The present study is initiated to evaluate quality of life, period of hospitalization and complication rates in patients with colorectal cancer receiving treatment with stoma surgery. Prior to surgery patients are randomized to different preoperative education programs. In Arm A patients receive a new specific education program (Krankenhaus Nordwest concept) conducted by a specialized therapist (stoma-therapist). In Arm B patients receive the standard preoperative education program. Standardized questionnaires are used to evaluate quality of life and period of hospitalization at baseline and four weeks after surgery in Arm A vs. Arm B

Evaluation of Quality of Life and Period of Hospitalization by Education

Clinical Trial to Evaluate Quality of Life, Period of Hospitalization and Complication Rates in Patients With Stoma Receiving Specific Preoperative Education vs. Standard Preoperative Education

Quality of life is assessed with EORTC QLQ-30 and EORTC QLQ-CR 29 at baseline, 9-15 days after surgery and 4 weeks after surgery. An improvement in Arm A is characterized by 10 points

Krankenhaus Nordwest

Musculoskeletal Diseases

Symptoms and General Pathology

Infections

Arthritis

Inflammation

Necrosis

Spondylitis

Spondylarthritis

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Spinal Diseases

Joint Diseases

Patient randomized in this arm will attend a 1 day long validated Therapeutic Education Program.

This program will take place within 6 months after biologic treatment initiation.

Patient randomized in this arm will not attend a Therapeutic Education Program within 12 months after biologic treatment initiation.

Patient will participate to a education program.

Christelle SORDET, MD

To describe, with a patient reported score (BIOSECURE), the influence of an approved therapeutic education program (TEP) in patients with joint inflammation requiring a biological treatment initiation.

The hypothesis is that patients attending the TEP will display better cognitive and adaptation competences than patients with no TEP.

Patient's reported quality of life, disease related stress management, treatment adherence, socio-demographic factors, biological home administration modalities and if the biologic treatment is maintained at 12 months, will also be described.

Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment

Impact of a Therapeutic Education Program in Patients With Non-radiological Spondyloarthritis Treated With Anti-tumor Necrosis Factor (TNF)

Patients will address questions and role play scenario evaluating cognitive and adaptive competences. The Biosecure score is between 0 and 100.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Quality of Life and Period of Hospitalization by Education	NCT02526264	Colorectal Canc...	Education progr...	18 Years -	Krankenhaus Nordwest
Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment	NCT03360864	Non-radiographi...	Education progr...	18 Years -	University Hospital, Strasbourg, France
Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment	NCT03360864	Non-radiographi...	Education progr...	18 Years -	University Hospital, Strasbourg, France

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