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Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer. (Rectqol)

Primary Purpose

Rectal Cancer, Surgery

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
quality of life
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Rectal Cancer focused on measuring rectal cancer, proctectomy, digestive sequelae, quality of life, Urinary and Sexual sequelae

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients operated for a rectal adénocarcinoma with a curative aim with or without neo-adjuvating treatment in Calvados between January 1st, 2007 (date of recommendations for clinical practise) and december 31 th, 2014.
  • Patients having their main address in the Calvados (at the time of diagnosis) and recorded in the register of digestive tumors of the Calvados.
  • patients alive on first of january 2018 without local recurrence nor global recurrence
  • patients able to understant a validated questionnaire.

Exclusion Criteria:

  • Dead patients
  • patients with cancer recurrence
  • Patient with severe cognitive disorders (confusions) preventing the good understanding of questionnaires.

Sites / Locations

  • François baclesse Center - U1086 - AnticipeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

population from registry data

Arm Description

the intervention involves completing several quality of life questionnaires validated in the medical literature (LARS score, FSFI, USP, IIEF, IPPS, QLQ C-30, QLQ-CR29)

Outcomes

Primary Outcome Measures

assessment of digestive sequelae in patients operated for a rectal cancer (rectal resection)
score used : LARS score (for men and women). 5 questions about the low anterior resection syndrom. Scale between 0 and 42 points. Better outcome is 0 and worse is 42.
assessment of global quality of life in patients operated for a rectal cancer (rectal resection)
Score used : EORTC - QLQ C-30 - European Organization for research and treatment of cancer Quality of Life Questionnaire Core 30 (for men and women). It is a scale to evaluate the generic quality of life after cancer. There are 30 questions : 28 questions with 4 possible answers from 1 to 4 and 2 questions to evaluate the physical state and global quality of life with answers between 1 and 7. For each answer, 1 is the worst outcome and 4 is the best except for the 2 last questions where 7 is the best outcome. Minimum (worst outcome) is 30 and best outcome is 126. The total is reported to a score of 100 points which is the best outcome.
assessment of specific quality of life in patients operated for a rectal cancer (rectal resection)
score used : EORTC - QLQ CR 29 European Organization for research and treatment of cancer Quality of Life Questionnaire Colorecatl module 29 (for men and women). This score is used in patients undergoing treatment for colorectal cancer. There are 29 questions with 4 possible answers (between 1 and 4 points). Best outcome is 4 for each question. Worst outcome is 1 for each question. Minimum (worst outcome) is 29 and best outcome is 116. The total is reported to a score of 100 points which is the best outcome.
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for women)
score used : Urinary Symptom Profile : USP (for women). This scale is used to evaluate urinary symptoms. 1 question to evaluate stress urinary incontinence (between 0 and 9 points). 9 points is the worts outcome. 7 questions to evaluate overactive bladder symtoms (between 0 points and 21). 21 points is the worst outcome. 3 questions to evaluate low stream symtoms (between 0 and 9 points). 9 points is the worst outcome. Global score is between 0 and 39 points. 39 points is the worst outcome and 0 points the best outcome.
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for men)
score used : International Prostate Score Symptom : IPSS (for men). There are 7 questions with 5 possible answers (between 0 (best outcome) and 5 (worst outcome)). And one additionnal question to evaluate quality of life due to urinary symptom with 7 possible answers from 0 (best outcome) to 6 (worst outcome). for the seven first questions : best outcome is 0 and worst outcome is 35. For the last question 0 is the best and 6 is the worst outcome).
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for women)
score used : Female Sexual Functionnal index : FSFI (for women). 19 questions on sexual sequelae in this questionnaire. Worst outcome is 2 and best outcome is 95 points.
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for men)
score used : International Index for Erectile Function 5 : IIEF 5 (for men). 5 questions for sexual quality of life in males. Each questions have 5 answers. 5 points is the best outcome for each question. Minimal score is 1 and best score (best outcome) is 25.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2017
Last Updated
May 16, 2018
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT03459235
Brief Title
Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer.
Acronym
Rectqol
Official Title
Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer Living After 2 Years Without Recurrence. Population Study. (Rectqol)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
April 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Total mesorectal excision and neoadjuvant radio-chemotherapy have revolutionized the management of rectal cancer allowing an increase in survival (between 55 and 68% at 5 years) and allowing a decrease of local recurrence (under 10%) and allowing to push the limits of sphinctyer saving procedures. Parallel to the oncological findings, evaluating quality of life and functionnals sequelae has become a priority as highlighted by the second axis of "plan cancer 2014-2019". The prevalence of digestive functional sequelae decrease during the first two years after surgery. However, these results are difficult to analyse due to the heterogeneity of used scores in medical litterature. The low anterior resection syndrom associate poly-exoneration, gas and / or stool incontinence, urgency and stool splitting. The score of low anterior resection " LARS score " validated in Danemark in 2012 allow us to understand the complexity of these sequelae and to measure their impact on the quality of life of patients, that's why he is currently recommended. In the long term, almost two out of three patients suffer from this syndrom, with half of the patients in a severe form. However, its prevalence and severity are often underestimated by practitioners. It leads to inappropriate therapeutic measures. The aim of this study is to evaluate the impact of digestive and genito-urinary sequelae on quality of life from validated scores in patients operated curatively of rectal cancer using a population study. This study should include 676 patients with rectal cancer treated in calvados and alive at 2 years of their proctectomy without local or general recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Surgery
Keywords
rectal cancer, proctectomy, digestive sequelae, quality of life, Urinary and Sexual sequelae

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
population from registry data
Arm Type
Experimental
Arm Description
the intervention involves completing several quality of life questionnaires validated in the medical literature (LARS score, FSFI, USP, IIEF, IPPS, QLQ C-30, QLQ-CR29)
Intervention Type
Other
Intervention Name(s)
quality of life
Intervention Description
Assessment of the impact of digestive sequelae (LARS score) and genitourinary sequelae (score IPSS, USP, FSFI et IIEF) in Patients With Rectal Cancer using validated questionnaires on quality of life (EORTC QLQ-C30 et QLQ-CR 29).
Primary Outcome Measure Information:
Title
assessment of digestive sequelae in patients operated for a rectal cancer (rectal resection)
Description
score used : LARS score (for men and women). 5 questions about the low anterior resection syndrom. Scale between 0 and 42 points. Better outcome is 0 and worse is 42.
Time Frame
more than 2 years after rectal resection
Title
assessment of global quality of life in patients operated for a rectal cancer (rectal resection)
Description
Score used : EORTC - QLQ C-30 - European Organization for research and treatment of cancer Quality of Life Questionnaire Core 30 (for men and women). It is a scale to evaluate the generic quality of life after cancer. There are 30 questions : 28 questions with 4 possible answers from 1 to 4 and 2 questions to evaluate the physical state and global quality of life with answers between 1 and 7. For each answer, 1 is the worst outcome and 4 is the best except for the 2 last questions where 7 is the best outcome. Minimum (worst outcome) is 30 and best outcome is 126. The total is reported to a score of 100 points which is the best outcome.
Time Frame
more than 2 years after rectal resection
Title
assessment of specific quality of life in patients operated for a rectal cancer (rectal resection)
Description
score used : EORTC - QLQ CR 29 European Organization for research and treatment of cancer Quality of Life Questionnaire Colorecatl module 29 (for men and women). This score is used in patients undergoing treatment for colorectal cancer. There are 29 questions with 4 possible answers (between 1 and 4 points). Best outcome is 4 for each question. Worst outcome is 1 for each question. Minimum (worst outcome) is 29 and best outcome is 116. The total is reported to a score of 100 points which is the best outcome.
Time Frame
more than 2 years after rectal resection
Title
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for women)
Description
score used : Urinary Symptom Profile : USP (for women). This scale is used to evaluate urinary symptoms. 1 question to evaluate stress urinary incontinence (between 0 and 9 points). 9 points is the worts outcome. 7 questions to evaluate overactive bladder symtoms (between 0 points and 21). 21 points is the worst outcome. 3 questions to evaluate low stream symtoms (between 0 and 9 points). 9 points is the worst outcome. Global score is between 0 and 39 points. 39 points is the worst outcome and 0 points the best outcome.
Time Frame
more than 2 years after rectal resection
Title
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for men)
Description
score used : International Prostate Score Symptom : IPSS (for men). There are 7 questions with 5 possible answers (between 0 (best outcome) and 5 (worst outcome)). And one additionnal question to evaluate quality of life due to urinary symptom with 7 possible answers from 0 (best outcome) to 6 (worst outcome). for the seven first questions : best outcome is 0 and worst outcome is 35. For the last question 0 is the best and 6 is the worst outcome).
Time Frame
more than 2 years after rectal resection
Title
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for women)
Description
score used : Female Sexual Functionnal index : FSFI (for women). 19 questions on sexual sequelae in this questionnaire. Worst outcome is 2 and best outcome is 95 points.
Time Frame
more than 2 years after rectal resection
Title
assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for men)
Description
score used : International Index for Erectile Function 5 : IIEF 5 (for men). 5 questions for sexual quality of life in males. Each questions have 5 answers. 5 points is the best outcome for each question. Minimal score is 1 and best score (best outcome) is 25.
Time Frame
more than 2 years after rectal resection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients operated for a rectal adénocarcinoma with a curative aim with or without neo-adjuvating treatment in Calvados between January 1st, 2007 (date of recommendations for clinical practise) and december 31 th, 2014. Patients having their main address in the Calvados (at the time of diagnosis) and recorded in the register of digestive tumors of the Calvados. patients alive on first of january 2018 without local recurrence nor global recurrence patients able to understant a validated questionnaire. Exclusion Criteria: Dead patients patients with cancer recurrence Patient with severe cognitive disorders (confusions) preventing the good understanding of questionnaires.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud Alves, MD, PhD
Phone
0033231063106
Email
alves-a@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Yassine Eid, MD
Phone
00332 31 45 86 25
Email
rectqol@gmail.com
Facility Information:
Facility Name
François baclesse Center - U1086 - Anticipe
City
Caen
State/Province
Normandie
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yassine Eid, MD
Phone
0033231458625
Email
rectqol@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17569477
Citation
Alves A. [Recommendations for clinical practice. Therapeutic choices for rectal cancer. How can we reduce therapeutic sequelae and preserve quality of life?]. Gastroenterol Clin Biol. 2007 Jan;31 Spec No 1:1S52-62, 1S95-7. No abstract available. French.
Results Reference
result
PubMed Identifier
28161008
Citation
Abdelli A, Tillou X, Alves A, Menahem B. Genito-urinary sequelae after carcinological rectal resection: What to tell patients in 2017. J Visc Surg. 2017 Apr;154(2):93-104. doi: 10.1016/j.jviscsurg.2016.10.002. Epub 2017 Feb 1.
Results Reference
result
PubMed Identifier
22504191
Citation
Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
Results Reference
result
PubMed Identifier
31204071
Citation
Eid Y, Bouvier V, Menahem B, Thobie A, Dolet N, Finochi M, Renier M, Gardy J, Launoy G, Dejardin O, Morello R, Alves A; Rectqol Group. Digestive and genitourinary sequelae in rectal cancer survivors and their impact on health-related quality of life: Outcome of a high-resolution population-based study. Surgery. 2019 Sep;166(3):327-335. doi: 10.1016/j.surg.2019.04.007. Epub 2019 Jun 14.
Results Reference
derived

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Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer.

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