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

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ClinicalTrials.gov Identifier: NCT03459235
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Surgery Other: quality of life Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer Living After 2 Years Without Recurrence. Population Study. (Rectqol)
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : April 15, 2018
Estimated Study Completion Date : June 15, 2018

Arm Intervention/treatment
Experimental: population from registry data
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)
Other: quality of life
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 Measures :
  1. assessment of digestive sequelae in patients operated for a rectal cancer (rectal resection) [ Time Frame: more than 2 years after 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.

  2. assessment of global quality of life in patients operated for a rectal cancer (rectal resection) [ Time Frame: more than 2 years after 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.

  3. assessment of specific quality of life in patients operated for a rectal cancer (rectal resection) [ Time Frame: more than 2 years after 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.

  4. assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for women) [ Time Frame: more than 2 years after rectal resection ]

    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.


  5. assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for men) [ Time Frame: more than 2 years after rectal resection ]
    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).

  6. assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for women) [ Time Frame: more than 2 years after rectal resection ]
    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.

  7. assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for men) [ Time Frame: more than 2 years after rectal resection ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459235


Contacts
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Contact: Arnaud Alves, MD, PhD 0033231063106 alves-a@chu-caen.fr
Contact: Yassine Eid, MD 00332 31 45 86 25 rectqol@gmail.com

Locations
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France
François baclesse Center - U1086 - Anticipe Recruiting
Caen, Normandie, France, 14000
Contact: Yassine Eid, MD    0033231458625    rectqol@gmail.com   
Sponsors and Collaborators
University Hospital, Caen

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03459235     History of Changes
Other Study ID Numbers: 2017 - A02645-48
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
rectal cancer
proctectomy
digestive sequelae
quality of life
Urinary and Sexual sequelae
Additional relevant MeSH terms:
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Digestive System Neoplasms
Digestive System Diseases
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases