Rectal CancerNCT03828318
Impact of a Patient-Centered Program for Low Anterior Resection Syndrome a Multicenter Randomized Controlled Trial
A study testing Patient Activation Booklet and nursing support for patients with LARS in people with Rectal Cancer and Surgery, run by Jewish General Hospital at 6 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rectal Cancer, Surgery, Patient Activation
- What is being tested?
- Patient Activation Booklet and nursing support for patients with LARS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Sep 2019to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada5 sites
Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Centre
Montreal, Quebec
CHU de Quebec
Québec, Quebec
Providence Healthcare
Vancouver, British Columbia
University of Manitoba
Winnipeg, Manitoba
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Rectal Cancer, Surgery, Patient Activation, Low Anterior Resection, Low Anterior Resection Syndrome
- Being tested
- Patient Activation Booklet and nursing support for patients with LARS
- Medical subject headings
- Rectal Neoplasms, Patient Participation, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Activation Arm | Experimental | Not described Receives: Other: Patient Activation Booklet and nursing support for patients with LARS |
| Standard Care Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global quality of life (QoL)
Measured by EORTC QLQ-C30
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Sep 2019
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Healthcare, McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre Hospitalier du Quebec, University of Manitoba
- Responsible party
- Principal investigator, Dr. Marylise Boutros, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828318
- Sponsor's protocol ID
- MP-05-2019-1628
- Status last verified
- Nov 2024
- First submitted
- 31 Jan 2019
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32474427
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Patient-Centered Program for Low Anterior Resection Syndrome a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03828318
- Acronym / sponsor ID
- MP-05-2019-1628
- Conditions
- Rectal Cancer, Surgery, Patient Activation, Low Anterior Resection, Low Anterior Resection Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Collaborators
- Providence Healthcare, McGill University Health Centre/Research Institute of the McGill University Health Centre, Centre Hospitalier du Quebec, University of Manitoba
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Activation Arm | Experimental | Other: Patient Activation Booklet and nursing support for patients with LARS |
| Standard Care Arm | No intervention | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Activation Booklet and nursing support for patients with LARSThe LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group. | Other | Patient Activation Arm |
Primary outcome
Global quality of life (QoL)
Time frame: 12 months
Measured by EORTC QLQ-C30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 32474427Garfinkle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Activation Booklet and nursing support for patients with LARS in people with Rectal Cancer and Surgery, run by Jewish General Hospital at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global quality of life (QoL) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03828318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.