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

Recruiting

• Conditions: Cancer; Malnutrition

• Registration Number: NCT06531174
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-20
• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-28
• Last Update Submitted: 2024-07-28
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Calf Circumference	Baseline, 1 month and 3 months	Measured on right and left calf

Secondary Outcome Measures

Name	Time	Method
Fat Free Mass and Fat Mass	Baseline, 1 month and 3 months	Measured with bioimpedance analysis
Food-Related Quality of Life	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.
Nutrition Impact Symptoms	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.
Muscle Function and Strength	Baseline, 1 month and 3 months	Measured with 30s chair stand test and hand dynamometer
Quality of Life	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'.
Energy and Protein Intake	Baseline, 1 month and 3 months	Measure with a repeated 24 h recall interview

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Sweden