~24 spots leftby Apr 2026

Patient Activation Program for Low Anterior Resection Syndrome

Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Jewish General Hospital
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

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
See 2 more

Treatment Details

Interventions

  • Patient Activation Booklet and nursing support (Behavioural Intervention)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Patient Activation ArmExperimental Treatment1 Intervention
Group II: Standard Care ArmActive Control1 Intervention

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
University of ManitobaWinnipeg, Canada
Providence HealthcareVancouver, Canada
Jewish General HospitalMontreal, Canada
CHU de QuebecQuébec, Canada
More Trial Locations
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Who Is Running the Clinical Trial?

Jewish General Hospital

Lead Sponsor

Trials
144
Patients Recruited
283,000+

University of Manitoba

Collaborator

Trials
628
Patients Recruited
209,000+

Providence Healthcare

Collaborator

Trials
19
Patients Recruited
3,500+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials
476
Patients Recruited
170,000+

Centre Hospitalier du Quebec

Collaborator

Trials
1
Patients Recruited
160+