Evaluation of Quality of Life and Period of Hospitalization by Education

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Education program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned stoma colorectal cancer, from resection of left hemi-colon aboral A. colica media Patients speaking german and living in Germany ECOG ≤ 3 Informed Consent standard education program Exclusion Criteria: Patients treated with stoma by emergency patients with dementia status post stoma Patients in contact with a stoma-therapist recurrence of colorectal cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Krankenhaus Nordwest Concept<br>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 | Other: Education program<br>* Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes<br>|
| Experimental: Standard concept<br>standard preoperative education program administered by a surgeon containing information on surgery, outcome, risks and alternatives | Other: Education program<br>* Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | 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 | 9-15 days after surgery | 
| Quality of Life | 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 | 4 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period of hospitalization |  | 9-15 days after surgery, 4 weeks after surgery | 
| Complication rates |  | 9-15 days after surgery, 4 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stoma, quality of life