Patient Reported Outcomes in Locally Recurrent Rectal Cancer
Research type
Research Study
Full title
International Validation of the Locally Recurrent Rectal Cancer - Quality of Life (LRRC-QoL) Questionnaire and a Longitudinal, Prospective, International Study of Patient Reported Outcomes in Locally Recurrent Rectal Cancer.
IRAS ID
272685
Contact name
Deena Harji
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
40831
Duration of Study in the UK
2 years, 0 months, 29 days
Research summary
Locally recurrent rectal cancer (LRRC) – cancer which returns close to the original site - affects approximately 10% of patients following treatment of rectal cancer. LRRC can cause symptoms, such as pain, bleeding and anal discharge. The only curative treatment for LRRC is extensive surgery in the form of an extended pelvic resection with 5-year survival rates of 43-63% following complete surgical resection, which is associated with high post-operative morbidity of up to 60%. The true extent of the burden of LRRC and its treatments on patients is unknown. The clinical and cancer-related outcomes are well documented, however, the extent of the impact on patients overall quality of life (QoL) is poorly reported. The LRRC-QoL is a questionnaire specifically designed for patients with LRRC to measure QoL. The LRRC-QoL was developed and validated for use in England and Australia. The best way to document outcomes related to QoL in this group is to collaborate with a number of high-volume, specialist centres internationally and to report outcomes related to QoL over a length of time.
This study aims to translate and validate the LRRC-QoL into a number of other languages to enable its international use. We will validate the LRRC-QoL questionnaire on an international platform. Validation means checking that the questionnaire is applicable across all the relevant patient groups. The data obtained from the serial measurements will be used to evaluate changes in quality in life over time. Comparisons in scores of quality of life will be examined between patients undergoing different treatments.
Survivorship issues represent the healthcare needs experienced by patients who have survived cancer treatment. As survival continues to improve in patients with LRRC and the number of survivors of exenterative surgery improves, it is important to understand the QoL and survivorship issues relevant to this cohort of patients.
REC name
West of Scotland REC 3
REC reference
20/WS/0116
Date of REC Opinion
8 Oct 2020
REC opinion
Further Information Favourable Opinion