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Exploring Individual Nutrition Care Elements and Nutritional Evaluation Methods Within Dietetic Practice in Cancer Care

Exploring Individual Nutrition Care Elements and Nutritional Evaluation Methods Within Dietetic Practice in Cancer Care

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06531174
Enrollment
150
Registered
2024-07-31
Start date
2024-06-20
Completion date
2026-12-31
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Malnutrition

Brief 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.

Interventions

None listed

Sponsors

Uppsala University Hospital
CollaboratorOTHER
Karolinska University Hospital
CollaboratorOTHER
Uppsala University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Calf CircumferenceBaseline, 1 month and 3 monthsMeasured on right and left calf

Secondary

MeasureTime frameDescription
Fat Free Mass and Fat MassBaseline, 1 month and 3 monthsMeasured with bioimpedance analysis
Food-Related Quality of LifeBaseline, 1 month and 3 monthsMeasured 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.
Energy and Protein IntakeBaseline, 1 month and 3 monthsMeasure with a repeated 24 h recall interview
Quality of LifeBaseline, 1 month and 3 monthsMeasured 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'.
Muscle Function and StrengthBaseline, 1 month and 3 monthsMeasured with 30s chair stand test and hand dynamometer
Nutrition Impact SymptomsBaseline, 1 month and 3 monthsMeasured 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.

Other

MeasureTime frameDescription
Categories and frequencies of Behaviour Change StrategiesBaselineFor part 1 of the project, data is collected by conversation recordings. The behaviour change taxonomy (v1) by Miche et al (2013) will be used to categorize and count the strategies.

Countries

Sweden

Contacts

Primary ContactEvelina Liljeberg, PhD
evelina.liljeberg@ikv.uu.se+46184715016
Backup ContactKarin Jontell, MSc
karin.jontell@ikv.uu.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026