Head and Neck Cancer Rehabilitation: the CaRe Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Programme feasibility
研究概览
简要总结
Introduction: As both the number of cancer survivors and the length of survival time are increasing, long-term health issues related to cancer and its treatment are becoming more prevalent. Research suggests that exercise can mitigate a number of negative health consequences of head and neck cancer and improve physical function and quality of life. Multi-modal exercise interventions have been proposed as a cornerstone for survivorship care. However, studies evaluating exercise programmes in head and neck cancer populations are lacking.
Purpose: To evaluate the feasibility and acceptability of a multi-modal exercise rehabilitation programme for survivors of head and neck cancer in a real-world, standard practice setting.
Methods and analysis: In this single-arm prospective feasibility study, survivors of head and neck cancer (n=29) will undergo a 10-week multi-modal exercise programme. The study population will comprise of cancer survivors attending outpatient services in an Irish national cancer centre. Participants will be aged 18 or older and have completed treatment with curative intent.
Feasibility will be evaluated in terms of recruitment, adherence and compliance to the programme. Secondary outcomes will examine physical function and quality of life measures. In addition, the acceptability of the programme will be assessed through patient feedback.
Ethics and dissemination: Ethical approval is pending from the St. James's Hospital and Tallaght University Hospital Research and Ethics Committee. The study results will be used to optimise the intervention content, and may serve as the foundation for a larger definitive trial. Results will be disseminated through peer-review journals, congresses and relevant clinical groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Informed Consent
- •Over 18 years old
- •In the first two years after treatment for head and neck cancer
- •Medically fit to participate in low to moderate physical activity
排除标准
- •Individuals with moderate or severe cognitive impairment
- •Pregnancy
- •Receiving treatment in the palliative setting
结局指标
主要结局
Programme feasibility
时间窗: From enrolment until end of study intervention at 10 weeks
Recruitment rates (percentage of eligible study population that consented to participation), programme adherence (number of prescribed supervised and unsupervised sessions completed), retention, acceptability of the intervention and adverse events. Reasons for attrition or non-compliance will be identified through qualitative evaluation with participants.
次要结局
- The Neck Disability Index(From enrolment until end of study intervention at 10 weeks)
- Quality of Life(From enrolment until end of study intervention at 10 weeks)
- Physical Function(From enrolment until end of study intervention at 10 weeks)
- Physical Activity(From enrolment until end of study intervention at 10 weeks)
- Cancer Related Fatigue(From enrolment until end of study intervention at 10 weeks)
- Oral Intake(From enrolment until end of study intervention at 10 weeks)
- Lymphoedema(From enrolment until end of study intervention at 10 weeks)
研究者
Grainne Sheill
Adjunct Assistant Professor
University of Dublin, Trinity College