We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    stella berkhoff
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02526264
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Colorectal Cancer Other: Education program

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : November 2015
Estimated Primary Completion Date : November 2017
Arms and Interventions

Arm Intervention/treatment
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
Other: Education program
Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes
Experimental: Standard concept
standard preoperative education program administered by a surgeon containing information on surgery, outcome, risks and alternatives
Other: Education program
Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes


Outcome Measures

Primary Outcome Measures :
  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 Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526264


Contacts
Contact: Stefan Berkhoff, MD +49697601 ext 4016 berkhoff.stefan@khnw.de
Contact: Gerrit zur Hausen, Dr. +49697601 ext 4562 zurhausen.gerrit@khnw.de

Locations
Germany
Krankenhaus Nordwest Recruiting
Frankfurt, Germany, 60488
Contact: Stefan Berkhoff, Doctor    +49 69 76014016    berkhoff.stefan@khnw.de   
Contact: Gerrit zur Hausen, Doctor    +49 69 76014562    zurhausen.gerrit@khnw.de   
Sana Klinikum Recruiting
Offenbach, Germany, 63069
Contact: Ulrike Wauer, MD    +49698405 ext 7106    ulrike.wauer@sana.de   
Contact: Beate Mantz    +49698405 ext 4403    beate.mantz@sana.de   
Sponsors and Collaborators
Krankenhaus Nordwest
More Information

Responsible Party: Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT02526264     History of Changes
Other Study ID Numbers: STELLA
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: August 2016

Keywords provided by Krankenhaus Nordwest:
stoma
quality of life

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases