After undergoing restorative proctectomy for rectal cancer, many patients are left with significant bowel dysfunction, known as Low Anterior Resection Syndrome (LARS). Increased LARS severity correlates with worse perceived global health status and quality of life (QoL). Among patients undergoing rectal resection with a permanent ostomy, there is evidence that supportive and educational interventions improve QoL, ostomy proficiency, self-efficacy and knowledge. However, evidence regarding the impact of such interventions in patients who undergo restorative proctectomy is lacking, despite the latter operation being far more frequently performed. The overall goal of this study is to evaluate the extent to which a LARS Patient-Centered Program impacts on patient-reported outcome measures (PROMs) after restorative proctectomy for rectal cancer. This is a randomized-controlled muticenter trial that will include patients who have undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy closure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
160
The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.
Massachusetts General Hospital
Boston, Massachusetts, United States
Providence Healthcare
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHU de Quebec
Québec, Quebec, Canada
Global quality of life (QoL)
Measured by EORTC QLQ-C30
Time frame: 12 months
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