Evaluation of Quality of Life and Period of Hospitalization by Education

Colorectal Cancer Clinical Trial

— STELLA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02526264
• Other study ID #: STELLA
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2015
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Krankenhaus Nordwest
• Contact: Stefan Berkhoff, MD
• Phone: +49697601
• Email: berkhoff.stefan[@]khnw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Other:
• Education program
Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes

Locations

Country	Name	City	State
Germany	Krankenhaus Nordwest	Frankfurt
Germany	Sana Klinikum	Offenbach

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Period of hospitalization		9-15 days after surgery, 4 weeks after surgery
Secondary	Complication rates		9-15 days after surgery, 4 weeks after surgery