Evaluation of Quality of Life and Period of Hospitalization by Education

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Other: Education program

• Registration Number: NCT02526264
• Lead Sponsor: Krankenhaus Nordwest

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Study Start: 2015-11-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Krankenhaus Nordwest Concept	Education program	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 concept	Education program	standard preoperative education program administered by a surgeon containing information on surgery, outcome, risks and alternatives

Primary Outcome Measures

Name	Time	Method
Quality of Life	4 weeks after surgery	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
Quality of life	9-15 days after surgery	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

Secondary Outcome Measures

Name	Time	Method
Period of hospitalization	9-15 days after surgery, 4 weeks after surgery
Complication rates	9-15 days after surgery, 4 weeks after surgery

Trial Locations

Locations (2)

Sana Klinikum; 🇩🇪 Offenbach, Germany

Krankenhaus Nordwest; 🇩🇪 Frankfurt, Germany