Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03516916 |
| Other study ID # |
490-98-0860 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2019 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Aarhus University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
This retrospective cohort study has three main aims: 1) To identify demographic and
socioeconomic factors influencing stoma impact and HRQoL, 2) To asses reliability and to
validate the translated and cross-cultural adapted CI score internationally in multiple
different centres, across a variety of patient groups and across cultural, religious,
socioeconomic and physical borders and 3) To investigate if differences in everyday stoma
care and -costs across countries and cultures affect CI or HRQoL.
International validation will be conducted as a retrospective cohort study on patients with a
permanent colostomy after curative intended surgery more than 12 months prior to inclusion.
Local health care professionals will identify includable patients and register relevant
clinical information on each patient from the hospital chart. Most centres will include
patients from national or regional databases, some will however include conveniently if a
database is not available. Our international collaborators will be responsible for sending
out and collecting the questionnaires and returning the completed questionnaires to the
undersigned. In countries with sufficient internet accessibility and -infrastructure the data
collection will be web based i.e. patients are sent a link to the redcap-database for them to
enter their answers directly. Some centres will employ paper versions of the questionnaires.
In areas with substantial number of illiterates investigator led interviews can be performed.
As the CI-score is a construct based on a formative model, statistical analysis based on the
Classical Test Theory(CCT) and Item Response Theory (IRT) cannot be applied. However, the
following aspects of validity and reliability from the Consensus-based Standards for the
selection of health Measurement Instruments (COSMIN) checklist15-17 can and will be
evaluated:
Content validity: Comprehensiveness and relevance of the questions in the CI-score have been
ensured with the way of the development of the CI-score with the starting point in a Basic
Stoma Questionnaire developed by an expert group supplemented by patients ensuring that all
possible factors affecting stoma function/impact was included before regression analysis lead
to the seven weighed questions1. After translation and cross-cultural adaptation
face-validity of each translated CI-score will be assessed again by the collaborators before
inclusion of patients.
Construct validity: This will be tested with hypothesis-testing. Hypotheses regarding mean
differences and expected correlations between scores of instruments are formulated a priori.
Hypotheses on how the CI-score and HRQoL are related to other factors are formulated a
priori. For convergent validation the CI-score will be tested against 5 anchor questions (not
validated) and the EORTC QLQ C30+ the colorectal specific CR29 (validated). Cross-cultural
validity: See translation section.
Reliability: For a randomly selected subgroup in each country the CI-score and anchor
question will be administered twice with an interval of approximately 2 weeks. The two
administrations will be independent and both the setting when answering and the forms of
administration will be similar for the individual patient. For ensuring stable patients an
extra question on recent changes in stoma function will be added to the retest.
Translation of the CI-score will be managed by the lead institution with few exceptions
(Turkey, Russia, Israel) and will follow the translation procedure recommended by the World
Health Organization. All translations are produced by a forward-backward procedure. The
latter procedure is performed to ensure, that the original meaning of the concepts is
derived.
The original Danish version of the CI-score has already undergone a professional translation
to English. A professional translation agency will perform the translation of the English
version to languages in the included countries. All questionnaires/Case Report Forms (CRF) to
be filled in by patients will undergo the same translation procedure as above.
A master version of the questionnaires will be collected into a booklet. On this basis, a
RedCap database will be constructed to allow for direct electronic data entry by patients.
Patient not able to access the web-based system, will fill in a paper version of the booklet.
According to variation between populations in respect to practically illiterate's
investigator lead data collection will be allowed. However, this should be agreed by the
local investigation and the steering group in the planning of the data collection and
included as individual amendment to the final protocol.
Data analysis:
Construct validity: Convergent validity will be studied by testing the CI-score on
APE/Hartmann-patients against two measures of HRQoL; the anchor-questions assessing the
overall stoma-impact on HRQoL, the EORTC QLQ C30 questionnaire version 3.0 and the EORTC QLQ
CR29. Construct validity will furthermore be assessed by hypothesis-testing assessing the
direction and magnitude of the expected correlations. Test-retest reliability will be studied
on a subgroup in all included countries. Also, we will include questions on background
demographics, socioeconomic status, everyday stoma care and -costs thereby enabling
investigation of the practical and economic aspect of living with a stoma varying from
country to country.
Statistical analysis:
Statistical analysis will be performed separately for each country. The correlations between
total CI-score, anchor questions and the EORTC questionnaire results will be calculated for
all participating patients according to the guidelines for the scores. For each CI-score
group (minor CI/major CI) the mean EORTC QLQ C30-score will be calculated, testing the
overall difference of impact on HRQoL between the CI-score groups.
Using the anchor-questions, the patients are divided into two HRQoL groups of those reporting
no/minor or some/major impact on HRQoL. Relationship between CI-score and HRQoL group will be
illustrated in box-plot for each country, where we expect statistically significant
differences in median CI-score between the two HRQoL groups. Differences will be tested by
Mann-Whitney U test. A contingency 2 by 2 table will be used to assess the degree of
agreement between the two CI-score groups and the two HRQoL groups. Based on this, the
sensitivity for the score will be calculated for each country. The added questions about
irrigation and stoma-bag change frequency will be compared country-wise. Univariate
regression analysis, descriptive analysis and estimation of impact on HRQoL will be
performed. Test-retest reliability will be evaluated using Intraclass Correlation Coefficient
and Cohens' Kappa.
