Exploring Individual Nutrition Care Elements and Nutritional Evaluation Methods Within Dietetic P… (NCT06531174) | Clinical Trial Compass
RecruitingNot Applicable
Exploring Individual Nutrition Care Elements and Nutritional Evaluation Methods Within Dietetic Practice in Cancer Care
Sweden150 participantsStarted 2024-06-20
Plain-language summary
The purpose of the study is to explore and deepen the understanding of the dietitian's role and work related to individually tailored nutritional treatment in cancer care. The research questions focus on behavior change strategies, goal setting, the possibility of using calf circumference to assess changes in muscle mass, and mapping energy and protein intake, nutritional symptoms, and food-related quality of life during nutritional treatment for cancer patients.
In the first part of the project, audio recordings of conversations between dietitians and patients with cancer will be conducted to investigate the dietitian's work with behavior change strategies and goal setting. Data analysis will be performed using two different methods: content analysis and thematic analysis. The research subjects include both dietitians and cancer patients who engage in conversations.
The second part of the project will include 100 patients with cancer at risk for or with malnutrition. Data collection will involve measurements of weight, height, calf circumference, muscle mass, energy and protein intake, nutritional symptoms, and food-related quality of life.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion criteria for the first part of the project involve encountering dietitians treating patients with cancer who have malnutrition or are at risk of malnutrition. For these patients, the inclusion criteria are as follows:
* aged ≥18 years with a diagnosed cancer
* ongoing nutrition therapy by a dietitian
* malnutrition or risk of malnutrition according to the hospitals criteria where at least one of the following criteria must be met: low BMI, involuntary weight loss, and/or eating difficulties. Patients can also be included if they are referred to a dietitian based on treatment guidelines due to a high risk of malnutrition associated with the cancer diagnosis or its medical therapy.
For the second part of the project, the inclusion criteria are:
* aged ≥18 years with a diagnosed cancer
* undergoing or planned treatment, including surgical, oncological, or a combination of these
* have been referred to a dietitian but have not yet had their initial contact with the dietitian, and
* malnutrition or risk of malnutrition according to the hospital's criteria, where at least one of the following criteria must be met: low BMI, involuntary weight loss, and/or eating difficulties. Patients can also be included if they are referred to a dietitian based on treatment guidelines due to a high risk of malnutrition associated with the cancer diagnosis or its medical therapy.
Exclusion Criteria:
For the first part of the project, the exclusion criteria regard…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.