跳至主要内容
临床试验/NCT05613699
NCT05613699已完成不适用

Implementation and Evaluation of Physical Exercise Services for Young Adults With Cancer

University Hospital Heidelberg2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
Feasibility of the three exercise interventions

研究概览

简要总结

Over the past decade, importance of supportive care in cancer treatment of young cancer patients has increased. However, most common cancer-related side effects, such as physical deconditioning, psychological problems, infertility, and cancer-related fatigue, are particularly problematic for young adults (AYA). Short- and long-term side effects result in impaired quality of life, social life, and physical activity levels. While there is growing evidence that physical exercise is effective in reducing disease- or treatment-related side effects, programs are generally not tailored to the unique needs of young adults. In addition, social media or web-based programs are rarely structurally integrated into existing care programs. The objective of the Your Exercise Program (YOUEX) study is therefore to address these specific needs and to improve physical exercise services for young people in Germany. To this end, this pilot study presents three approaches to physical activity enhancement, with a particular focus on web-based and cross-regional programs. All three approaches will be evaluated for their feasibility and effectiveness on fatigue, distress, quality of life, and activity levels, as well as sustained effects over 24 weeks. The YOUEX study is an exploratory intervention study in the form of a 12-week exercise program for patients aged 18 to 39 years who currently have or have had a cancer diagnosis within the past 5 years. Eligible patients can choose from three support programs: Social Media Exercise Program, Online Exercise Platform, Supervised Exercise Program. The goal is to recruit 70 to 80 patients over an 8-month period. Evaluation questionnaires will be sent at three time points (T0: start of exercise program, T1: after 6 weeks; T2: after 12 weeks; T3: after 24 weeks) with a short weekly questionnaire between T0 and T2 to assess weekly adherence and changes in fatigue. YOUEX study will collect detailed information on the acceptability and feasibility of different physical activity programs for young people and their lasting effects on fatigue, quality of life and physical activity. Should these be positive, the findings can directly inform health care practice, which would be highly relevant especially in light of the COVID pandemic.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • cancer diagnosis within the past five years
  • signed informed consent

排除标准

  • cancer-related cognitive impairment
  • lack of sports clearance from the attending oncologist (e.g. in case of fragile bone metastases)
  • current participation in another exercise intervention
  • insufficient German language skills

结局指标

主要结局

Feasibility of the three exercise interventions

时间窗: During 12 week of the intervention

Participants ability to follow the exercise prescription (measured by % of training frequency as well as type of the exercise)

次要结局

  • Health-related quality of life(Baseline, 6 weeks, 12 weeks, 24 weeks)
  • Physical activity level(12 weeks and 24 weeks)
  • Module Selection and preferences(Baseline, 6 weeks, 12 weeks)
  • Fatigue Thermometer(Daily till week 12)
  • Impact of COVID-19 pandemic(Baseline, 6 weeks, 12 weeks, 24 weeks)
  • Fatigue(Baseline, 6 weeks, 12 weeks, 24 weeks)
  • Patient Satisfaction(Baseline, 6 weeks, 12 weeks, 24 weeks)
  • Social Support(Baseline, 6 weeks, 12 weeks, 24 weeks)
  • Distress(Baseline, 6 weeks, 12 weeks, 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joachim Wiskemann

Head Exercise Oncology

University Hospital Heidelberg

研究点 (2)

Loading locations...

相似试验