Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial
Primary Purpose
Rectal Cancer, Surgery, Patient Activation
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Patient Activation Booklet and nursing support for patients with LARS
Sponsored by
About this trial
This is an interventional supportive care trial for Rectal Cancer
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
- Patients who have undergone major colonic resection in addition to their proctectomy
- Patients on active chemotherapy or radiotherapy treatment
Sites / Locations
- Massachusetts General Hospital
- Providence HealthcareRecruiting
- University of ManitobaRecruiting
- Jewish General HospitalRecruiting
- McGill University Health CentreRecruiting
- CHU de QuebecRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patient Activation Arm
Standard Care Arm
Arm Description
Outcomes
Primary Outcome Measures
Global quality of life (QoL)
Measured by EORTC QLQ-C30
Secondary Outcome Measures
Full Information
NCT ID
NCT03828318
First Posted
January 31, 2019
Last Updated
August 17, 2022
Sponsor
Jewish General Hospital
Collaborators
Providence Healthcare, McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre Hospitalier du Quebec, University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT03828318
Brief Title
Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial
Official Title
Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital
Collaborators
Providence Healthcare, McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre Hospitalier du Quebec, University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Surgery, Patient Activation, Low Anterior Resection, Low Anterior Resection Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient Activation Arm
Arm Type
Experimental
Arm Title
Standard Care Arm
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Patient Activation Booklet and nursing support for patients with LARS
Intervention Description
The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.
Primary Outcome Measure Information:
Title
Global quality of life (QoL)
Description
Measured by EORTC QLQ-C30
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Patients who have undergone major colonic resection in addition to their proctectomy
Patients on active chemotherapy or radiotherapy treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aashiyan Singh, Msc(A)
Phone
514-340-8222
Ext
25996
Email
aashiyan.singh@ladydavis.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Demian, Msc
Phone
514-340-8222
Ext
25996
Email
mdemian@jgh.mcgill.ca
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Stafford
Email
CSTAFFORD2@partners.org
First Name & Middle Initial & Last Name & Degree
Liliana Bordeianou
Facility Name
Providence Healthcare
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willis Cao
Email
wcao1@providencehealth.bc.ca
First Name & Middle Initial & Last Name & Degree
Carl Brown
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Sabboobeh
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marylise Boutros, MD, MSc, FRCSC, FACS. FABCRS
Phone
514-340-8222
Ext
6821
Email
maryliseboutros@gmail.com
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Sabboobeh
Email
sarah.sabboobeh@ladydavis.ca
First Name & Middle Initial & Last Name & Degree
Sender Liberman
Facility Name
CHU de Quebec
City
Québec
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Wright
Email
ann.wright@chudequebec.ca
First Name & Middle Initial & Last Name & Degree
Sebastien Drolet
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32474427
Citation
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.
Results Reference
derived
Learn more about this trial
Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial
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