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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.

Study ID: 46607
Short Title: Patient Reported Outcomes in Locally Recurrent Rectal Cancer
Trust Name: UHS
Recruitment Site: Southampton General Hospital
Disease Area: Colorectal cancer SPCPS
Phase: N/A
Expected End Date: 04/12/2023
Postcode: SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria for phase I: • aged > = 18 years; • with radiological and/or histological diagnosis of LRRC; • or have undergone treatment (surgery/chemotherapy/radiotherapy) for LRRC within the last 2 years; • able to provide informed written consent to participate and; • able to read and write in the target language. For phase II: • aged > = 18 years; • with a new radiological and/or histological diagnosis of LRRC; • able to provide informed written consent to participate and; • able to read and write in the target language. For phase III: • aged > = 18 years; • treated for LRRC and are disease-free for more than 3 years; • able to provide informed written consent to participate and; • able to read and write in the target language.

For phases I and II: • have cognitive impairment • are in remission from treatment of primary rectal cancer with no evidence of local recurrence • receiving treatment for distant metastatic disease (i.e. liver, lung) following previous treatment of rectal cancer with no evidence of local recurrence. For phase III: • have cognitive impairment • have been treated for LRRC and disease-free for less than 3 years. • diagnosis or treatment for distant metastatic disease (i.e. liver, lung) or locally re-recurrent rectal cancer following previous treatment for LRRC.

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.

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