High Intensity Functional Training in the Rehabilitation of Cancer Survivors: A Protocol for a Pragmatic Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Health related quality of life
研究概览
简要总结
The primary aim of this study is to investigate changes in health related quality of life (HRQoL) and cancer-related fatigue (CRF) following a 16-weeks of HIFT as a part of the rehabilitation of cancer survivors.
Additionally, we will investigate the continuation of participation in any High Intensity Functional Training (HIFT) program, three as well as 12 months following completion of the exercise intervention.
The intervention containing high intensity functional training will take place in a pragmatic clinical setting at the Center for Cancer and Health in Copenhagen.
We hypothesize that the HIFT will be be associated with improved HRQoL and CRF.
详细描述
Sample size Due to the exploratory nature of this study, no power calculation will be conducted. As the inclusion of participants will be consecutive, the anticipated number of included participants will be estimated based on the average monthly number of patients that begins the group based training during clinical practise at the centre. The average number of patients who is referred to the rehabilitation centre and who begins the HIFT training every month is 6 and thus, it is expected that a total of approximately 30 participants will be included in this study during a 22-week consecutive inclusion period that runs from august 5th 2019 to January 5th. All participants will be asked to complete both baseline-, end point- and three-month follow-up assessment.
Recruitment Due to the pragmatic design there will be no recruitment though advertisement. Recruitment will take place by asking eligible patients referred to CCHC, if they would like to participate in the study. This recruitment will take place during an initial rehabilitation planning session with a physiotherapist two days prior to the first HIFT session. Patients will be made aware that they have two days to consider participating in the study (informed consent material and written participant information can be found in appendix 3).
Methods: Data collection, management and analysis Data collection methods Plan for assessment and collection of outcomes All primary and secondary outcomes are participant-reported and will be administered through the online survey tool: SurveyXact. All included participants will receive an email with an electronic SurveyXact-invitation to the baseline questionnaire the same days as providing written consent to participate in the study. On the day of the final HIFT session (week 16), the participants will receive a similar SurveyXact-invitation with the end-point questionnaire. The three and 12-month follow up assessments will be administered in identical ways to the end-point assessment.
Patient characteristics Demographic variables will be included in the baseline questionnaire. These will include self-reported information about: sex, body mass index, educational level, employment, smoking status and physical activity level, and will be collected together with information on cancer type, time since cancer diagnosis, time since active treatment and cancer treatment type (See table 1 for data collection time points of patient characteristics and patient-reported outcome measures).
Registration of adverse events, plans to promote participant retention and complete follow up:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Health related quality of life
时间窗: For each participant at baseline + end point at 16 weeks + follow up at 3 month and 12 months)
Change in HRQoL from baseline to end point and from end point to follow up at 3 and 12 months, will be evaluated using the Global Health Status/Quality of Life item from the EORTC QLQ-C-30 questionnaire. EORTC QLQ-C-30 includes five functional domains (physical, role, cognitive, emotional and social, where higher scores represent greater function or quality of life) and three symptom scales (fatigue, pain and nausea). Functional and symptom scales range from 0 to 100. Higher values on functional scales equal a higher level of functioning. Higher values on symptom scales equal higher symptom burden. EORTC QLQ-C-30 is chosen for it's established reliability and validity with specific emphasis on use in cancer populations
次要结局
- Symptoms and function(For each participant at baseline + end point at 16 weeks + follow up at 3 month and 12 months))
- Leisure time physical activity level(Time frame for each participant: Baseline + end point at 16 weeks + follow up at 3 months and 12 months)
- Continued participation in high intensity functional training (post-intervention)(Time frame: for each participant at follow up at 3 month and 12 months)
研究者
Andreas Lund Hessner
Principal investigator
University of Copenhagen