Intervention Phase: Patient-centered Nutrition Care (PaCC II)
试验速览
- 阶段
- 不适用
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Stabilization of patient-reported nutrition nutrition status
研究概览
简要总结
The aim of this study is to utilize the E-Health platform (EHIP) containing behavioural tipps to enable the provision of early appropriate nutrition recommendations to patients undergoing cancer therapy thereby stabilizing the nutrition status as measured with the scored Patient-Generated Subjective Global Assessment. Furthermore, we plan to explore the causal pathway between the change in the number and severity of nutrition related symptoms, measure the difference in weight change in percent between the two groups, determine a change in the level of the distress status, and measure the change in functional status. This Information could provide a basis for future nutrition intervention strategies aimed at improving overall nutrition status of patients undergoing cancer therapy and could potentially improve clinical and functional outcomes of this population.
详细描述
Primary Endpoint:
Nutrition care, augmented with E-Health tools containing tailored behavioural tipps enable the maintenance of overall nutrition status 12 weeks from baseline as measured with the Scored Patient-Generated Subjective Global Assessment. .
Secondary Endpoints will include:
- difference in the two arms in % weight loss
- difference in the number and severity of further Patient Reported nutrition relation symptoms according to Patient Reported- Common Toxicity Criteria for adverse events (PRO-CTCAE™) developed by the Division of Cancer Control and Population Sciences in the National Cancer Institute Version date: 2/25/2019
- change in Quality of Life as measured by Functional Assessment of Cancer Therapy - General questionnaire
- improvement of nutrition status
- change in the % of estimated energy intake achieved
- difference of the number of discontinuations or delay in therapy
- difference of Glasgow Prognostic Score (only when C-reactive protein und Albumin are available in the routine blood draw)
- change in Distress status
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients with tumors in the GI tract undergoing chemo and/or Immunotherapy and are primarily treated on an outpatient basis
- •≥ 18 years
- •Life expectancy ≥ 6 months
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- •Open for, and ability to use, of E-Health platforms (own and uses one or more electronic devices with access to internet)
- •Able to take 75% of foods orally
- •Valid declaration of consent to participate in the study
排除标准
- •Cancer patients with other diagnoses or who are not receiving chemo or Immunotherapy or undergoing intensive therapy requiring longer in-patient stays (e.g: Intensive Care Patients)
- •≤ 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3
- •More than 75% of Energy intake is not taken oral but instead via enteral or parenteral route.
- •Operation planned during the course of the Study (next 3 months)
- •Patient who do provide not or withdraw their consent
- •Not open or willing to use E-Health tools
结局指标
主要结局
Stabilization of patient-reported nutrition nutrition status
时间窗: 12 weeks from baseline
A automated analysis embedded in the E-health tool will provide patient-tailored nutrition information and behavior advice aimed at stabilizing or improving nutrition status. Nutrition status will be measured using the scored Patient-Generated Subjective Global Assessment (scale of 1-36) whereas a higher score indicates a declining nutrition status
次要结局
- Inflammation status(12 weeks from baseline)
- Weight change(12 weeks from baseline)
- Discontinuations or delay in therapy reduction(12 weeks from baseline)
- Number and severity of patient-reported nutrition related symptoms between the groups(12 weeks from baseline)
- Improvement of nutrition intake(12 weeks from baseline)
- Quality of life improvement(12 weeks from baseline)
- Distress status(12 weeks from baseline)
研究者
PD Dr. med. Volker Heinemann
Professor Doktor
Ludwig-Maximilians - University of Munich