- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437326
Food-related Quality of Life in Patients With Cancer (QVA-Mod)
Modeling the Influence of Pathological Factors, Oral Symptoms and Sensory Perception on Food-related Quality of Life in Patients With Cancer
Food plays a fundamental role in quality of life. In patients with cancer psychological burden and treatment-related side effects can impact appetite, taste perception and pleasure of eating, making nutritional management more challenging.
Given the central role of food and nutrition in maintaining physical health and psychological well-being, it is essential to better understand the factors that contribute to food-related quality of life in order to improve the quality of life of patients with cancer. Despite the importance of these psychological aspects, current assessments tools do not adequately measure the impact of cancer on the food-related quality of life.
In a study entitled "CANUT-QVA" a specific questionnaire measuring nine dimensions of food related quality of life was developed, allowing for a better understanding of how patients perceive and experience their diet. This instrument consists of 46 items and explores nine dimensions, its use showing a significant decrease in food related quality of life of patients with breast cancer, opening the way for targeted interventions to improve nutritional well being and overall quality of life in cancer patients.
The present study aims to analyse various factors - such as oral health, sensory profile and clinical characteristics - associated with food-related quality of life in patients with cancer (gastrointestinal, head and neck, lung, breast and gynecologic cancer) during or after treatment, in order to develop a predictive model of food related quality of life. The main objective of this project is to identify the population at highest risk, so as to better tailor nutritional interventions for patients with cancer, considering both the type of treatment received and the phase, during or after treatment. The food-related quality of life questionnaire containing 46 items will be used to measure the primary outcome.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Amandine BRUYAS, Dr
- Phone Number: +33 478861628
- Email: amandine.bruyas@chu-lyon.fr
Study Contact Backup
- Name: Irina Elena ANTOCHI
Study Locations
-
-
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Bron, France
- Hôpital Femme Mère Enfant
-
Contact:
- Marie BEGUINOT, Dr
- Email: marie.beguinot-cornillon@chu-lyon.fr
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Lyon, France
- Hopital de la croix rousse
-
Contact:
- Amandine BRUYAS, Dr
- Phone Number: +33 478861628
- Email: amandine.bruyas@chu-lyon.fr
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Oullins, France
- Hôpital Lyon Sud
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Contact:
- Benoit YOU, Pr
- Email: benoit.you@chu-lyon.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients with different types of cancer gastrointestinal, breast, gynecologic, head and neck, lung, aged between 18 years or older. Two cohorts are considered: patients under treatment (chemotherapy, targeted therapy, immunotherapy, etc., except patients undergoing head and neck radiotherapy) from at least two months and patients having undergone anticancer treatment having completed it at least 3 months and no more than 12 months before inclusion.
The necessary number of patients is 180, 90 patients in each cohort.
Description
Inclusion Criteria:
- Patient aged 18 years or older;
- Patient with gastrointestinal, breast, gynecologic, head and neck, lung
- Patient receiving a cancer treatment (chemotherapy, targeted therapy, immunotherapy, etc.) from at least two months;
- Patients having undergone anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc.) having completed it at least 3 months and no more than 12 months before inclusion;
- Patient capable of filling a questionnaire;
- Patient having given his free, informed and express consent.
Exclusion Criteria:
- - Patient having a radiotherapy treatment for a head or neck cancer;
- Patient having presented nausea and vomiting during the last 24 hours;
- Patient with severe inflammation of the mouth or throat (ulcers, mucus);
- Patient with cognitive disorders and memory loss;
- Pregnant women or breastfeeding;
- Adult under legal protection (guardianship, curatorship).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients under treatment
Patients with cancer (gastrointestinal, breast, head and neck, gynecologic, lung), under treatment from at least two months, receiving active anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc., except patients undergoing head and neck radiotherapy) in a standard of care program.
|
Self-reported questionnaires will be used to asses patient's food-related quality of life (QVA questionnaire), global quality of life (EORTC QLQ-C30 questionnaire), evaluation of oral symptoms and perceptions.
Objective tests will be performed to measure the salivary quality and quantity and taste and smell perceptions.
|
|
Patients after treatment
Patients who have undergone anticancer treatment (chemotherapy, targeted therapy, immunotherapy, etc.) having completed it at least 3 months and no more then 12 months before inclusion.
|
Self-reported questionnaires will be used to asses patient's food-related quality of life (QVA questionnaire), global quality of life (EORTC QLQ-C30 questionnaire), evaluation of oral symptoms and perceptions.
Objective tests will be performed to measure the salivary quality and quantity and taste and smell perceptions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The food-related quality of life in patients with cancer (gastrointestinal, breast, head and neck, gynecologic, lung).
Time Frame: day of inclusion
|
The food-related quality of life questionnaire containing 46 items will be used to measure the outcome.
The questionnaire uses a Likert scale: 1 = never; 2 = sometimes; 3 = often; 4 = always.
|
day of inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amandine BRUYAS, Dr, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Respiratory Tract Diseases
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Neoplasms
- Lung Neoplasms
- Breast Neoplasms
- Gastrointestinal Neoplasms
- Head and Neck Neoplasms
Other Study ID Numbers
- 69HCL25_0908
- 2025-A02292-47 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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