Brief Summary

The formation of a colostomy following surgery for rectal cancer changes body image, challenges patient practical skills and threatens quality of life. As the oncological results have improved over the last decades the number of survivors from rectal cancer who have to adjust to a cancer free life in their own homes is increasing. To enable the identification of the patients with stoma-related reduced health-related Quality of life (HRQoL) in a quick and reliable way we recently developed the Colostomy Impact Score (CI-score) comprising 7 items of stoma related factors with significant impact on HRQoL. The purpose of the present project is to perform an international validation of the CI-score and to demonstrate its applicability. The construct validity of the CI-score will be studied internationally on crosssectional cohorts of patients with permanent colostomy after abdominoperineal excision (APE) or Hartmann's procedure in Denmark, Sweden, Spain, the Netherlands, United Kingdom, Turkey, Brazil, Egypt, Russia, Lithuania, Israel, Portugal, South Africa, Australia and China. This will be done by testing the CI-score against five anchor questions stoma impact on HRQoL, the 5 Level version og the EuroQol measuer (EQ-5D-5L) and version 3.0 of the Quality of Life Questionnaire from the European Organisation for Research and Treatment of Cancer (EORTC QLQ C30 questionnaire v3.0). The impact of the challenges related to having a stoma may vary with different demographic, socioeconomic and cultural factors. Supplementary data on stoma care, demographics and socioeconomic status will be gathered to study the impact of patient-related factors and cultural differences on HRQoL in rectal cancer survivors with an ostomy.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

3,750

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Feb 2019

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

April 24, 2018

Completed

13 days until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed

9 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed

Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

10 months

First QC Date

April 24, 2018

Last Update Submit

November 14, 2020

Conditions

Rectal Neoplasms Quality of Life Colostomy Stoma

Keywords

Rectal cancer, HRQoL, Stoma, Colostomy, Patient reported outcome measure (PROM)

Outcome Measures