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

NCT ID: NCT06531174

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-20

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uppsala University Hospital

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Evelina Liljeberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uppsala University

Uppsala, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Evelina Liljeberg, PhD

Role: CONTACT

Phone: +46184715016

Email: [email protected]

Karin Jontell, MSc

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Evelina Liljeberg, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

240901

Identifier Type: -

Identifier Source: org_study_id