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NCT Number: NCT06531174

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University

Uppsala, Sweden

Location status: Recruiting

Location contact

Evelina Liljeberg, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Primary outcomes

  1. Calf Circumference

    Time frame: Baseline, 1 month and 3 months

    Measured on right and left calf

Secondary outcomes

  1. Fat Free Mass and Fat Mass

    Time frame: Baseline, 1 month and 3 months

    Measured with bioimpedance analysis

  2. Food-Related Quality of Life

    Time frame: Baseline, 1 month and 3 months

    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.

  3. Energy and Protein Intake

    Time frame: Baseline, 1 month and 3 months

    Measure with a repeated 24 h recall interview

  4. Nutrition Impact Symptoms

    Time frame: Baseline, 1 month and 3 months

    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.

  5. Quality of Life

    Time frame: Baseline, 1 month and 3 months

    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'.

  6. Muscle Function and Strength

    Time frame: Baseline, 1 month and 3 months

    Measured with 30s chair stand test and hand dynamometer

Other outcomes

  1. Categories and frequencies of Behaviour Change Strategies

    Time frame: Baseline

    For 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Evelina Liljeberg, PhD

CONTACT

[email protected]

+46184715016

Karin Jontell, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Karolinska University Hospital
  • Uppsala University Hospital

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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