Evaluation of Quality of Life and Period of Hospitalization by Education

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT02526264

Studienbeginn:
November 2015

Letztes Update:
06.03.2024

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Krankenhaus Nordwest

Collaborator:
-

Kontakt

Stefan Berkhoff, MD
Kontakt:
Phone: +49697601
Phone (ext.): 4016
E-Mail: berkhoff.stefan@khnw.de» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

Onkologisches Zentrum Krankenhaus Nordwest
Steinbacher Hohl 2-26
60488 Frankfurt am Main
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Stefan Berkhoff, Doctor
Phone: +49 69 76014016
E-Mail: berkhoff.stefan@khnw.de» Ansprechpartner anzeigen

Brustzentrum im Sana Klinikum Lichtenberg
Fanningerstraße 32
10365 Berlin
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Ulrike Wauer, MD
Phone: +49698405
Phone (ext.): 7106
E-Mail: ulrike.wauer@sana.de

Beate Mantz
Phone: +49698405
Phone (ext.): 4403
E-Mail: beate.mantz@sana.de» Ansprechpartner anzeigen

Studien-Informationen

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

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Quality of life (Time Frame - 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

2. Quality of Life (Time Frame - 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

Secondary outcome:

1. Period of hospitalization (Time Frame - 9-15 days after surgery, 4 weeks after surgery)

2. Complication rates (Time Frame - 9-15 days after surgery, 4 weeks after surgery)

Studien-Arme

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

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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