Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04893876 |
| Other study ID # |
MP-05-2021-2615 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
September 30, 2029 |
Study information
| Verified date |
August 2022 |
| Source |
Jewish General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Advances in rectal cancer management have significantly reduced morbidity and mortality. The
most commonly performed operation for rectal cancer is restorative proctectomy (RP), leaving
up to 70% with long-term bowel dysfunction called Low Anterior Resection Syndrome (LARS).
LARS manifests as stool frequency, incontinence and difficult defecation. LARS, along with
other functional impairments such as sexual and urinary dysfunction (SUD), can impact quality
of life (QoL) and cause emotional distress. High-quality longitudinal data on these sequalae
are lacking, leading to variable estimates of their prevalence, risk factors and prognosis.
Most studies are European, cross-sectional, lack pre-treatment evaluation and long-term
follow-up, and use inconsistent assessment measures. Thus, a North American study that
evaluates patients longitudinally from diagnosis will provide quality data to fill this
knowledge gap.
The main aim of the proposed study is to contribute evidence regarding the impact of LARS,
SUD, emotional/financial distress, and patient activation on long-term post-treatment QoL in
North American rectal cancer after RP.
This multicenter North American, observational, prospective cohort study relies on validated
patient reported outcome measures (PROMs) at diagnosis, during and post-treatment. Patients
from 20 sites will be recruited over 2 years and followed for 3 years. The primary endpoint
is QoL as measured by the European Organization for Research & Treatment of Cancer QoL
questionnaire. We anticipate accrual of 1200 patients. Factors associated with QoL will be
explored. Impact of patient activation in relation to functional outcomes on QoL over time
will be explored using a difference-in-differences approach. The study involves a
multidisciplinary team who will provide expertise in research methodology, nursing, oncology
and surgery.
The main contributions of this study are 1) provision of reference baseline North American
values for important rectal cancer PROMs for clinical and research use, 2) an understanding
of the evolution of functional outcomes and QoL post-treatment to counsel patients
peri-operatively and throughout survivorship, and 3) to provide the basis for future tailored
programs to support rectal cancer survivors.
Description:
Advances in rectal cancer management have significantly reduced morbidity and mortality. The
most commonly performed operation for rectal cancer is restorative proctectomy (RP), leaving
up to 70% with long-term bowel dysfunction called Low Anterior Resection Syndrome (LARS).
LARS manifests as stool frequency, incontinence and difficult defecation. LARS, along with
other functional impairments such as sexual and urinary dysfunction (SUD), can impact quality
of life (QoL) and cause emotional distress. There is no well-established treatment strategy
for LARS or SUD. High-quality longitudinal data on these sequalae are lacking, leading to
variable estimates of their prevalence, risk factors and prognosis. Most studies are
European, cross-sectional, lack pre-treatment evaluation and long-term follow-up, and use
inconsistent assessment measures. Thus, a North American study that evaluates patients
longitudinally from diagnosis will provide quality data to fill this knowledge gap.
The main aim of the proposed study is to contribute evidence regarding the impact of LARS,
SUD, emotional/financial distress, and patient activation on long-term post-treatment QoL in
North American rectal cancer after RP. This study aims to address the following research
questions: 1): How do North American rectal cancer patients who underwent RP experience
changes in function (bowel, sexual and urinary), distress (emotional and financial) and QoL
after RP from baseline through early and late timepoints following treatment? 2): How do
patient-, disease-, treatment-, functional- and distress-related factors predict QoL at
baseline and at early and late timepoints post-treatment?
This multicenter North American, observational, prospective cohort study relies on validated
patient reported outcome measures (PROMs) at diagnosis, during and post-treatment. Patients
from 20 sites will be recruited over 2 years and followed for 3 years. The primary endpoint
is QoL as measured by the European Organization for Research & Treatment of Cancer QoL
questionnaire. We anticipate accrual of 1200 patients. Estimating a 30% attrition rate, in
1000 different simulated datasets and α=0.05, we will be able to detect a 1 point difference
in QoL 88% of the time (95%CI: 85.8, 90.0). Given that a 10-point difference is considered
clinically significant, this sample size affords good precision. 1) QoL, LARS, SUD,
emotional/financial distress will be measured at baseline, early (12 & 18 months) and late (2
& 3 years) timepoints. 2) Changes over time for each outcome will be studied using linear
mixed models (LMM) and generalized LMM as appropriate to account for the hierarchical and
longitudinal structure of the data. 3) Factors associated with QoL will be explored using
LMM. 4) Impact of patient activation in relation to functional outcomes on QoL over time will
be explored using a difference-in-differences approach. The study involves a
multidisciplinary team who will provide expertise in research methodology, nursing, oncology
and surgery.
The main contributions of this study are 1) provision of reference baseline North American
values for important rectal cancer PROMs for clinical and research use, 2) an understanding
of the evolution of functional outcomes and QoL post-treatment to counsel patients
peri-operatively and throughout survivorship, and 3) to provide the basis for future tailored
programs to support rectal cancer survivors.
