Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Providence Healthcare | OTHER |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
| Centre Hospitalier du Quebec | UNKNOWN |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Activation Arm | Experimental |
| |
| Standard Care Arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Activation Booklet and nursing support for patients with LARS | Other | The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group. |
| Measure | Description | Time Frame |
|---|---|---|
| Global quality of life (QoL) | Measured by EORTC QLQ-C30 | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Providence Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32474427 | Derived | Garfinkle R, Loiselle CG, Park J, Fiore JF Jr, Bordeianou LG, Liberman AS, Morin N, Faria J, Ghitulescu G, Vasilevsky CA, Bhatnagar SR, Boutros M. Development and evaluation of a patient-centred program for low anterior resection syndrome: protocol for a randomized controlled trial. BMJ Open. 2020 May 30;10(5):e035587. doi: 10.1136/bmjopen-2019-035587. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| University of Manitoba |
| OTHER |
Not provided
Not provided
Not provided
Not provided
| Vancouver |
| British Columbia |
| Canada |
| University of Manitoba | Winnipeg | Manitoba | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| McGill University Health Centre | Montreal | Quebec | Canada |
| CHU de Quebec | Québec | Quebec | Canada |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D010358 | Patient Participation |
| D000094123 | Low Anterior Resection Syndrome |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003108 | Colonic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007935 | Leucine-tRNA Ligase |
| ID | Term |
|---|---|
| D000604 | Amino Acyl-tRNA Synthetases |
| D019729 | Carbon-Oxygen Ligases |
| D008025 | Ligases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
Not provided
Not provided