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

NCT06531174 | Recruiting

• 1 other identifier: 240901
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Malnutrition

Outcome Measures

Primary Outcomes (1)

• Calf Circumference

  Measured on right and left calf

  Baseline, 1 month and 3 months

Secondary Outcomes (6)

• Fat Free Mass and Fat Mass

  Baseline, 1 month and 3 months

• Food-Related Quality of Life

  Baseline, 1 month and 3 months

• Energy and Protein Intake

  Baseline, 1 month and 3 months

• Nutrition Impact Symptoms

  Baseline, 1 month and 3 months

• Quality of Life

  Baseline, 1 month and 3 months

Other Outcomes (1)

• Categories and frequencies of Behaviour Change Strategies

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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
• 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.

You may not qualify if:

• known dementia or impaired cognitive function, and
• not proficient in spoken and written Swedish.
• known dementia or impaired cognitive function,
• not proficient in spoken and written Swedish.

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Uppsala University

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Evelina Liljeberg, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelina Liljeberg, PhD

CONTACT

+46184715016; evelina.liljeberg@ikv.uu.se

Karin Jontell, MSc

CONTACT

karin.jontell@ikv.uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 31, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)