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临床试验/NCT06531174
NCT06531174招募中不适用

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

Uppsala University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Calf Circumference

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Calf Circumference

时间窗: Baseline, 1 month and 3 months

Measured on right and left calf

次要结局

  • Fat Free Mass and Fat Mass(Baseline, 1 month and 3 months)
  • Food-Related Quality of Life(Baseline, 1 month and 3 months)
  • Nutrition Impact Symptoms(Baseline, 1 month and 3 months)
  • Muscle Function and Strength(Baseline, 1 month and 3 months)
  • Quality of Life(Baseline, 1 month and 3 months)
  • Energy and Protein Intake(Baseline, 1 month and 3 months)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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