Evaluation of Quality of Life and Period of Hospitalization by Education (STELLA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Education program

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 Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Berkhoff, MD; Phone Number: 4016 +49697601; Email: berkhoff.stefan@khnw.de

Study Locations

• Germany
  • Frankfurt, Germany, 60488
    • Recruiting
    • Krankenhaus Nordwest
    • Contact: Stefan Berkhoff, Doctor; Phone Number: +49 69 76014016; Email: berkhoff.stefan@khnw.de
  • Offenbach, Germany, 63069
    • Recruiting
    • Sana Klinikum
    • Contact: Ulrike Wauer, MD; Phone Number: 7106 +49698405; Email: ulrike.wauer@sana.de
    • Contact: Beate Mantz; Phone Number: 4403 +49698405; Email: beate.mantz@sana.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Krankenhaus Nordwest

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2015
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimated): August 18, 2015

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; stoma
• Other Study ID Numbers: STELLA (Baylor College of Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared