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

Krankenhaus Nordwest

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Other: Education program

Study type: Interventional

Funder types: Other

Identifiers

NCT02526264

STELLA

Details and patient eligibility

About

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.

Full 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

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Krankenhaus Nordwest Concept

Experimental group

Description:

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

Treatment:

Other: Education program

Standard concept

Experimental group

Description:

standard preoperative education program administered by a surgeon containing information on surgery, outcome, risks and alternatives

Treatment:

Other: Education program