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Impact on the Nutritional State and the Quality of Life

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ClinicalTrials.gov Identifier: NCT01687335
Recruitment Status : Unknown
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : September 18, 2012
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date October 6, 2011
First Posted Date September 18, 2012
Last Update Posted Date September 1, 2014
Study Start Date September 2011
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 17, 2012)
  • quality of life's improvement [ Time Frame: 3 YEARS ]
  • improvement of treatment effectiveness, [ Time Frame: 3 YEARS ]
  • improvement of their survival [ Time Frame: 3 YEARS ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01687335 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 17, 2012)
  • improvement of the screening of the undernutrition [ Time Frame: 3 YEARS ]
  • the answer to the treatment [ Time Frame: 3 years ]
  • the estimation of the survival with regard to the nutritional state of the patient. [ Time Frame: 3 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact on the Nutritional State and the Quality of Life
Official Title Conformity With European Recommendations Concerning the Nutritional Care of the Cancerous Patients Benefiting From a Treatment by Chemotherapy Impact on the Nutritional State and the Quality of Life
Brief Summary

The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is variable in function: the location and the extension of the tumor, of the general state , of age, of the socio-economic class and the pain. The health consequences of a malnutrition are very important: aggravation of the state of health, complications of treatment, hospitalization, alteration of the quality of life and decrease the survival, and the treatment response.

Nutrition being very important in patients, there are recommendations for the nutritional care of these patients, formulated by the European Society for Clinical Nutrition and Metabolism. The investigators do not know to what extent these recommendations are respected in practice and their influence on the nutritional status and the quality of life of patients.

The investigators therefore propose to assess the conformity of the nutritional care patients in clinical practice in relation to the European recommendations and in a second time to assess the influence of this compliance or non-compliance on the nutritional status clinical and biological of cancerous patients under chemotherapy, on their quality of life, on their response to treatment and on their survival.

The investigators will try to identify factors that may be linked to the non-compliance such as the characteristics of the cancer disease, socio-demographic characteristics of the subject and the factors related to the structure in which it is supported.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population cancerous patients benefiting from a treatment by chemotherapy
Condition Cancer
Intervention Other: answering questionnare in differents time of the treatment
Study Groups/Cohorts cancerous patients
the patients benefiting from treatment by chemotherapy.
Intervention: Other: answering questionnare in differents time of the treatment
Publications * Salas S, Mercier S, Moheng B, Olivet S, Garcia ME, Hamon S, Sibertin-Blanc C, Duffaud F, Auquier P, Baumstarck K. Nutritional status and quality of life of cancer patients needing exclusive chemotherapy: a longitudinal study. Health Qual Life Outcomes. 2017 Apr 27;15(1):85. doi: 10.1186/s12955-017-0660-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 17, 2012)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2015
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18-year-old subject in 85 years in the inclusion
  • Subject presenting a cancerous pathology requiring a systematic treatment by exclusive chemotherapy for a minimal duration of three months with a plan of 3 cures of chemotherapy with an interval between the cures of 21 days
  • Presenting subject one of these 4 cancerous pathologies: cancer of the aéro-digestive ways superiors, sarcomas, colorectal cancers, broncho-lung cancers
  • Subject having the capacity of lira and to understand(include) French
  • Subject having signed lit(enlightened) consent
  • Subject taken care for its cancerous pathology in one of the partner services of the project
  • Subject affiliated to the national insurance scheme

Exclusion Criteria:

  • Subject having benefited from a major surgical operation in 4 weeks preceding the inclusion
  • Subject having benefited from a radiotherapy in two weeks before the inclusion
  • Subject minor(miner), pregnant woman, subject incapable to give its consent, subject under supervision(guardianship) - guardianship
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01687335
Other Study ID Numbers 2011-A00631-40
2011-11 ( Other Identifier: AP HM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor Assistance Publique Hopitaux De Marseille
Collaborators Not Provided
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date August 2014