Surviving Rectal Cancer at the Cost of a Colostomy International Validation of the Colostomy Impact Score

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.

Conditions

• Rectal Neoplasms
• Quality of Life
• Colostomy Stoma

Interventions

OTHER

Questionnaires on HRQoL and sociodemography

All patients are asked to answer a panel of questionnaires to test validity and reliability of the Colostomy Impact Score.

Sponsors & Collaborators

• Eloy Espin, Department of Surgery, Universidad Autonoma de Barcelona

  collaborator UNKNOWN

• Kelly Buzatti, Federal University of Minas Gerais

  collaborator UNKNOWN

• Dong Pang, Peking University School of Nursing

  collaborator UNKNOWN

• Mansoura University

  collaborator OTHER

• Edgar Furnee, University Medical Center, Groningen

  collaborator UNKNOWN

• Annika Sjövall, Karolinska Institute, Stockholm

  collaborator UNKNOWN

• Tomas Poskus, Faculty of Medicine, Vilnius University

  collaborator UNKNOWN

• Sheba Medical Center

  collaborator OTHER_GOV

• Andrea Warwick, Redcliffe and QEII Jubilee Hospitals

  collaborator UNKNOWN

• Nuno Rama,Centro Hospitalar Leiria Pombal

  collaborator UNKNOWN

• Aarhus University Hospital

  lead OTHER

Principal Investigators

• Helle Ø Kristensen, MD · Danish Cancer Society Centre for Research on Survivorship and Late Adverse Effects After Cancer in the Pelvic Organs, Department of Surgery, Aarhus University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-01

Primary Completion

2019-12-01

Completion

2020-12-31

Countries

• Denmark

Study Locations