Food-related Quality of Life in Patients With Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
- 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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Self-reported questionnaires
Other interventionSelf-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.
Salivary and sensory tests
Other interventionObjective tests will be performed to measure the salivary quality and quantity and taste and smell perceptions.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Patients under treatment2 interventions
Group B: Patients after treatment2 interventions
Trial outcomes
Primary outcomes
1
The food-related quality of life in patients with cancer (gastrointestinal, breast, head and neck, gynecologic, lung).
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.
Time frame
day of inclusionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: