Evaluation of Quality of Life and Period of Hospitalization by Education

NCT ID: NCT02526264

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-24

Study Completion Date

2025-09-30

Brief Summary

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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

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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

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Education program

Intervention Type OTHER

Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes

Standard concept

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

Group Type EXPERIMENTAL

Education program

Intervention Type OTHER

Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes

Interventions

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Education program

Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Krankenhaus Nordwest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Krankenhaus Nordwest

Frankfurt, , Germany

Site Status RECRUITING

Sana Klinikum

Offenbach, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefan Berkhoff, MD

Role: CONTACT

+49697601 ext. 4016

Facility Contacts

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Stefan Berkhoff, Doctor

Role: primary

+49 69 76014016

Ulrike Wauer, MD

Role: primary

+49698405 ext. 7106

Beate Mantz

Role: backup

+49698405 ext. 4403

Other Identifiers

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STELLA

Identifier Type: -

Identifier Source: org_study_id

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