Low Anterior Resection, Low Anterior Resection Syndrome, Patient Activation, Rectal Cancer, Surgery
Conditions
Brief summary
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.
Interventions
OTHERPatient Activation Booklet and nursing support for patients with LARS
The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.
Sponsors
Providence Healthcare
McGill University Health Centre/Research Institute of the McGill University Health Centre
Centre Hospitalier du Quebec
University of Manitoba
Jewish General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>=18 years-old) 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
Exclusion criteria
* Patients from whom clear and informed consent cannot be obtained * Patients unable to read and comprehend English or French * Patients who cannot be contacted by telephone * Patients who have undergone major colonic resection in addition to their proctectomy * Patients on active chemotherapy or radiotherapy treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global quality of life (QoL) | 12 months | Measured by EORTC QLQ-C30 |
Countries
Canada, United States
Outcome results
None listed