NCT03828318

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

4.4 years

First QC Date

January 31, 2019

Last Update Submit

November 26, 2024

Conditions

Rectal CancerSurgeryPatient ActivationLow Anterior ResectionLow Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (1)

  • Global quality of life (QoL)

    Measured by EORTC QLQ-C30

    12 months

Study Arms (2)

Patient Activation Arm

EXPERIMENTAL
Other: Patient Activation Booklet and nursing support for patients with LARS

Standard Care Arm

NO INTERVENTION

Interventions

Patient Activation Booklet and nursing support for patients with LARSOTHER

The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.

Patient Activation Arm

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Providence Healthcare

Vancouver, British Columbia, Canada

Location

University of Manitoba

Winnipeg, Manitoba, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

CHU de Quebec

Québec, Quebec, Canada

Location

Related Publications (1)

  • 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.

    PMID: 32474427DERIVED

MeSH Terms

Conditions

Rectal NeoplasmsPatient ParticipationLow Anterior Resection Syndrome

Interventions

Leucine-tRNA Ligase

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorColonic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acyl-tRNA SynthetasesCarbon-Oxygen LigasesLigasesEnzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Colorectal Surgeon

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 4, 2019

Study Start

September 1, 2019

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(5)US(1)