CancerNCT06531174
Exploring Individual Nutrition Care Elements and Nutritional Evaluation Methods Within Dietetic Practice in Cancer Care
An observational study of Cancer and Malnutrition, run by Uppsala University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malnutrition
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jun 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the first part of the project (non-probability sampling method), research participants are registrered dietitians in Sweden and patients with cancer who have malnutrition or are at risk of malnutrition. The participants are recruited systematically through a strategic or purposive selection within the hospital setting. For the second part of the project (probability sampling method), research participants are patients aged ≥18 years with a diagnosed cancer who are receiving or scheduled to receive treatment, including surgical, oncological, or a combination of these, at Uppsala University Hospital in Uppsala. The patients should have been referred to a dietitian but have not yet had their initial contact with the dietitian at the time of inclusion.
Who may be able to join
- 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
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- 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.
Who cannot join
- For the first part of the project, the exclusion criteria regarding patients are:
- known dementia or impaired cognitive function, and
- not proficient in spoken and written Swedish.
- For the second part of the project, the exclusion criteria are:
- known dementia or impaired cognitive function,
- ongoing nutrition therapy by a dietitian at inclusion, and
- not proficient in spoken and written Swedish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Karin Jontell, MSc contact
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University
Uppsala
Evelina Liljeberg, PhD, evelina.liljeberg@ikv.uu.se
About this study
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.
- Conditions
- Cancer, Malnutrition
- Medical subject headings
- Neoplasms, Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Calf Circumference
Measured on right and left calf
Measured: Baseline, 1 month and 3 months
Secondary outcomes (6)
Fat Free Mass and Fat Mass
Measured with bioimpedance analysis
Measured: Baseline, 1 month and 3 months
Food-Related Quality of Life
Measured with the questionnaire Satisfaction with Food-Related Life. This instrument contains seven statements where the participant responds on a seven-point scale from 'Strongly disagree' to 'Strongly agree'. A higher rating indicates a worse outcome.
Measured: Baseline, 1 month and 3 months
Energy and Protein Intake
Measure with a repeated 24 h recall interview
Measured: Baseline, 1 month and 3 months
Nutrition Impact Symptoms
Measured with the Eating Symptoms Questionnaire (13 symtoms to be rated on a five-level scale from no trouble at all to severe) and the Disease-Related Appetite Questionnaire (11 questions about appetite, hunger and other symtoms). A higher number of symtoms indicates a worse outcome.
Measured: Baseline, 1 month and 3 months
Quality of Life
Measured with the instrument EORTC QLQ-C30. Includes 28 symptoms or issues, each rated on a four-level scale from 1= 'not at all' to 4 = 'very much. A higher score indicates a worse outcome. The lowest aggregated score of the instrument is 28 and the highest is 112. The instrument also contains two questions where one is to rate their overall health and quality of life on a seven-level scale from 1= 'Very poor" to 7= 'Excellent'.
Measured: Baseline, 1 month and 3 months
Muscle Function and Strength
Measured with 30s chair stand test and hand dynamometer
Measured: Baseline, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start20 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, Karolinska University Hospital
- Responsible party
- Sponsor
- Investigators
- Evelina Liljeberg, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531174
- Sponsor's protocol ID
- 240901
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Individual Nutrition Care Elements and Nutritional Evaluation Methods Within Dietetic Practice in Cancer Care
- ClinicalTrials.gov ID
- NCT06531174
- Acronym / sponsor ID
- 240901
- Conditions
- Cancer, Malnutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, Karolinska University Hospital
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the first part of the project (non-probability sampling method), research participants are registrered dietitians in Sweden and patients with cancer who have malnutrition or are at risk of malnutrition. The participants are recruited systematically through a strategic or purposive selection within the hospital setting. For the second part of the project (probability sampling method), research participants are patients aged ≥18 years with a diagnosed cancer who are receiving or scheduled to receive treatment, including surgical, oncological, or a combination of these, at Uppsala University Hospital in Uppsala. The patients should have been referred to a dietitian but have not yet had their initial contact with the dietitian at the time of inclusion.
Key inclusion criteria (9 listed)
- 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.
- aged ≥18 years with a diagnosed cancer
Key exclusion criteria (7 listed)
- known dementia or impaired cognitive function, and
- not proficient in spoken and written Swedish.
- known dementia or impaired cognitive function,
- ongoing nutrition therapy by a dietitian at inclusion, and
- not proficient in spoken and written Swedish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calf Circumference
Time frame: Baseline, 1 month and 3 months
Measured on right and left calf
6 secondary outcomes
Fat Free Mass and Fat Mass
Time frame: Baseline, 1 month and 3 months
Food-Related Quality of Life
Time frame: Baseline, 1 month and 3 months
Energy and Protein Intake
Time frame: Baseline, 1 month and 3 months
Nutrition Impact Symptoms
Time frame: Baseline, 1 month and 3 months
Quality of Life
Time frame: Baseline, 1 month and 3 months
Muscle Function and Strength
Time frame: Baseline, 1 month and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karin Jontell, MSc contact
Evelina Liljeberg, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Malnutrition, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evelina Liljeberg, PhD (+46184715016, evelina.liljeberg@ikv.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calf Circumference (time frame: Baseline, 1 month and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024; AzTrials last refreshed its copy on 3 Nov 2026.