STELLA: Evaluation of Quality of Life and Period of Hospitalization by Education

Sponsor

Krankenhaus Nordwest (Other)

Overall Status

Recruiting

CT.gov ID

NCT02526264

Collaborator

(none)

138

Enrollment

Locations

Arms

69.3

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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	Phase
Colorectal Cancer	Other: Education program	N/A

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

Anticipated 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

Actual Study Start Date :

Nov 24, 2015

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

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

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

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
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

Secondary Outcome Measures

Period of hospitalization [9-15 days after surgery, 4 weeks after surgery]
Complication rates [9-15 days after surgery, 4 weeks after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krankenhaus Nordwest	Frankfurt		Germany	60488
2	Sana Klinikum	Offenbach		Germany	63069

Sponsors and Collaborators

Krankenhaus Nordwest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Krankenhaus Nordwest

ClinicalTrials.gov Identifier:

NCT02526264

Other Study ID Numbers:

STELLA

First Posted:

Aug 18, 2015

Last Update Posted:

Sep 10, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Krankenhaus Nordwest

stoma

quality of life

Study Results

No Results Posted as of Sep 10, 2020