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
1 other identifier
interventional
138
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Nov 2015
Longer than P75 for not_applicable colorectal-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedStudy Start
First participant enrolled
November 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedMarch 6, 2024
March 1, 2024
9.5 years
August 10, 2015
March 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Period of hospitalization
9-15 days after surgery, 4 weeks after surgery
Complication rates
9-15 days after surgery, 4 weeks after surgery
Study Arms (2)
Krankenhaus Nordwest Concept
EXPERIMENTALspecific 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
EXPERIMENTALstandard preoperative education program administered by a surgeon containing information on surgery, outcome, risks and alternatives
Interventions
Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients treated with stoma by emergency
- patients with dementia
- status post stoma
- Patients in contact with a stoma-therapist
- recurrence of colorectal cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Krankenhaus Nordwest
Frankfurt, 60488, Germany
Sana Klinikum
Offenbach, 63069, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2015
First Posted
August 18, 2015
Study Start
November 24, 2015
Primary Completion
June 1, 2025
Study Completion
September 1, 2025
Last Updated
March 6, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
No IPD will be shared