Advances in rectal cancer management have significantly reduced morbidity and mortality. The most commonly performed operation for rectal cancer is restorative proctectomy (RP), leaving up to 70% with long-term bowel dysfunction called Low Anterior Resection Syndrome (LARS). LARS manifests as stool frequency, incontinence and difficult defecation. LARS, along with other functional impairments such as sexual and urinary dysfunction (SUD), can impact quality of life (QoL) and cause emotional distress. High-quality longitudinal data on these sequalae are lacking, leading to variable estimates of their prevalence, risk factors and prognosis. Most studies are European, cross-sectional, lack pre-treatment evaluation and long-term follow-up, and use inconsistent assessment measures. Thus, a North American study that evaluates patients longitudinally from diagnosis will provide quality data to fill this knowledge gap.
The main aim of the proposed study is to contribute evidence regarding the impact of LARS, SUD, emotional/financial distress, and patient activation on long-term post-treatment QoL in North American rectal cancer after RP.
This multicenter North American, observational, prospective cohort study relies on validated patient reported outcome measures (PROMs) at diagnosis, during and post-treatment. Patients from 20 sites will be recruited over 2 years and followed for 3 years. The primary endpoint is QoL as measured by the European Organization for Research \& Treatment of Cancer QoL questionnaire. We anticipate accrual of 1200 patients. Factors associated with QoL will be explored. Impact of patient activation in relation to functional outcomes on QoL over time will be explored using a difference-in-differences approach. The study involves a multidisciplinary team who will provide expertise in research methodology, nursing, oncology and surgery.
The main contributions of this study are 1) provision of reference baseline North American values for important rectal cancer PROMs for clinical and research use, 2) an understanding of the evolution of functional outcomes and QoL post-treatment to counsel patients peri-operatively and throughout survivorship, and 3) to provide the basis for future tailored programs to support rectal cancer survivors.
Patients >18 years with histopathologically confirmed adenocarcinoma of the rectum, defined as tumor ≤15cm from the anal verge who are planned for RP ± neoadjuvant treatment or WW (CRT alone without surgery).
Metastatic disease at diagnosis;
Planned for abdominoperineal resection (APR), low Hartmann's or pelvic exenteration (PE);
Cannot be contacted by telephone;
Unable to read and comprehend English or French;
All consecutive patients \>18 years with histopathologically confirmed primary rectal cancer ≤15cm from the anal verge who are planned for curative treatment.
Cohort
Prospective
Not listed
Global Quality of Life (QoL)
Global QoL as measured by the European Organization for Research \& Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). Linear transformation is used to standardize raw score, so that scores range from 0 to 100; higher score represents better functioning or worse level of symptoms.
Low Anterior Resection Syndrome Score
Measured by the Low Anterior Resection Syndrome Score (LARS Score). Score ranges from 0 to 42 points. 0-20: no LARS; 21-29 minor LARS; 30-42 major LARS.
Female Sexual Dysfunction
Measured for females by the Female Sexual Function Index (FSFI). FSFI: Minimum score 0, maximum score 36; higher score means better sexual function.
Male Sexual Dysfunction
Measured for males by the International Index of Erectile Function (IIEF). IIEF: Minimum score 0, maximum score 30. Higher score means better sexual function; higher score means better sexual function.
Female Urinary Dysfunction
Measured for females by the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). ICIQ-FLUTS: Minimum score 0, maximum score 48; Higher score means worse urinary symptoms.
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