Multiphasic Prehabilitation in Patients Undergoing Surgery for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Quality of life: Functional Assessment of Cancer Therapy-Head and Neck Version 4 (FACT-H&N)
研究概览
简要总结
Implementing a multiphasic, multimodal prehabilitation intervention for people undergoing surgery with free flap reconstruction for the treatment of head and neck cancer.
详细描述
BACKGROUND: Head and neck cancer (HNC) is the 7th most common cancer worldwide, and treatment often involves surgery. HNC surgery is intensive, complications are common, and quality of life (QOL) is negatively impacted. Support must be expanded to not only help patients survive HNC but to recover faster and live well following surgery. Prehabilitation, or optimizing a patient's condition before surgery, is a key opportunity to integrate supportive care early in the clinical care pathway for this underserved patient group. RESEARCH DESIGN AND METHODS: Using a mixed-methods approach, the aims of this hybrid implementation-effectiveness study are to (i) implement a multiphasic exercise prehabilitation program for HNC patients in a real-world setting and describe factors influencing implementation across the phases; (ii) determine the safety and tolerability of a multiphasic exercise prehabilitation program for HNC patients; (iii) explore the potential benefits of a multiphasic exercise prehabilitation program for HNC patients, and (iv) build a systematic screening and referral pathway into exercise oncology resources post-operatively. Outcomes are detailed below and include patient-reported outcomes, physical function, mobility (step count) and hospital length of stay.
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
- •Aged ≥18 years;
- •Histologically verified primary head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or in lymph nodes of the neck from an unknown primary tumour
- •Scheduled to undergo oncologic resection or resection for benign disease with free flap reconstruction
- •Approval received from a clinical exercise physiologist (CSEP-CEP) and/or clinician
- •Ability to provide written informed consent and understand study information in English
排除标准
- •Neurological or musculoskeletal co-morbidity inhibiting exercise
- •Diagnosed psychotic, addictive, or major cognitive disorders
- •Severe coronary artery disease (Canadian Cardiovascular Society class III or greater)
- •Significant congestive heart failure (New York Heart Association class III or greater)
结局指标
主要结局
Quality of life: Functional Assessment of Cancer Therapy-Head and Neck Version 4 (FACT-H&N)
时间窗: Baseline, 6 weeks, 6 months and 12 months after surgery (6 months is primary).
Total score ranges from 0-156. A higher score is a better outcome.
次要结局
- Self-reported moderate and strenuous physical activity score: Godin Leisure-Time Exercise Questionnaire (GLTEQ)(Pre-intervention, 6 weeks after surgery, 6 and 12 months after cancer treatment)
- Self-reported physical activity (leisure score index): Godin Leisure-Time Exercise Questionnaire (GLTEQ)(Baseline, 6 weeks after surgery, 6 and 12 months after cancer treatment)
- Fatigue severity: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F). Total score.(Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up)
- Weekly step counts(Phase 3 (0-6 weeks after hospital discharge))
- Weekly "intensity minutes"(Phase 3 (0-6 weeks after hospital discharge))
- Anxiety score: Hospital Anxiety and Depression Scale (HADS)(Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up)
- Self-reported health status: EQ VAS (visual analogue) score(Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up)
- Mobilization after surgery (ii)(The in hospital period after surgery (typically 10-14 days))
- Symptom burden: Edmonton Symptom Assessment System (ERAS-r).(Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up)
- Functional exercise capacity (total steps)(Before surgery, 6 weeks after surgery, 6 and 12 months follow-up)
- Hospital length of stay (total number of days)(The in-hospital period after surgery (from surgery to hospital discharge))
- Number of complications(Within 1 year after surgery.)
- Depression score: Hospital Anxiety and Depression Scale (HADS)(Baseline, 10-14 days after surgery, 6 weeks after surgery, 6 and 12 months follow-up)
- Single-leg balance (s)(Before surgery, 6 weeks after surgery, 6 and 12 months follow-up)
- Lower-limb muscular endurance (number of sit-to-stands)(Before surgery, 6 weeks after surgery, 6 and 12 months follow-up)
- Mobilization after surgery (i)(The mean of the hospital period after surgery (typically 10-14 days))