NUTRI-HAB - A Randomised Controlled Trial on the Effect of a Targeted Residential Rehabilitation Program With a Focus on Eating Problems After Treatment for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Percentage change in body weight from baseline to follow up
研究概览
简要总结
The study is a randomised controlled trial that aims to test the effect of a residential rehabilitation program with a focus on eating problems after treatment in head and neck cancer survivors. The study will furthermore investigate whether selected nutrition screening and assessment tools can be used to identify head and neck cancer survivor who benefit from the program.
详细描述
This study is a randomised controlled trial with following objectives:
- To test the effect of a targeted residential rehabilitation program with focus on the physical, psychological and social aspects of eating problems on body weight, health-related quality of life and physical function in curatively treated head and neck cancer survivors 1-5 years after completion of radiation therapy
- To test whether a potential effect of the program is associated with/dependent of the participants' score in Scores Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF), Nutrition Risk Screening 2002 (NRS 2002) or M.D. Anderson Dysphagia Inventory (MDADI) at baseline
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 (Investigator)
盲法说明
The investigator will be blinded when performing the data analyses. Hence, data will be anonymised before analysis and the investigator will not know whether the group of subjects were allocated to the control or the intervention group.
Results from blinded data analyses will be interpreted by project group before unblinding.
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 of the larynx, pharynx or oral cavity
- •Treatment with radiation therapy completed 1-5 years before inclusion
- •Curatively treated
- •Expression of interest in participating in the rehabilitation program in a preceding survey
- •Self-reliant and no need for assistance with personal hygiene etc.
排除标准
- •Active cancer disease at the time of recruitment
- •Not being able to speak and understand Danish
- •No permanent residence in Denmark
结局指标
主要结局
Percentage change in body weight from baseline to follow up
时间窗: Difference between measurements at baseline and at follow-up after 3 and 6 months
Body weight will be measured with a calibrated scale at baseline and at follow up. Measurements will be performed by trained health professionals and standardised protocols will be followed. The change in percent will be calculated for each individual participant and be used as the primary outcome.
次要结局
- Change in health-related quality of life (EORTC QLQ-C30) from baseline to follow up(Difference between measurements at baseline and at follow-up after 3 and 6 months)
- Percentage change in '30 seconds sit-to-stand-test' from baseline to follow up(Difference between measurements at baseline and at follow-up after 3 and 6 months)
- Percentage change in '6 minutes walk test' from baseline to follow up(Difference between measurements at baseline and at follow-up after 3 and 6 months)
- Percentage change in mouth opening from baseline to follow up(Difference between measurements at baseline and at follow-up after 3 and 6 months)
- Change in health-related quality of life (EORTC QLQ-H&N35) from baseline to follow up(Difference between measurements at baseline and at follow-up after 3 and 6 months)
- Percentage change in hand grip strength from baseline to follow up(Difference between measurements at baseline and at follow-up after 3 and 6 months)
- Change in health-related quality of life (EQ-5D-5L) from baseline to follow up(Difference between measurements at baseline and at follow-up after 3 and 6 months)
- Change in symptoms of anxiety and depression from baseline to follow up(Difference between measurements at baseline and at follow-up after 3 and 6 months)
研究者
Marianne Boll Kristensen
PhD student, Clinical dietitian
Odense University Hospital