Colorectal Cancer
Conditions
Keywords
stoma, quality of life
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
Interventions
OTHEREducation program
Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes
Sponsors
Krankenhaus Nordwest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| 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 |
Countries
Germany
Contacts
Primary ContactStefan Berkhoff, MD
Outcome results
None listed