Impact of prehabilitation on Cancer Related Fatigue (CRF), Functional Capacity and Quality of life (QOL) of Head and Neck Cancer patients undergoing neck dissection surgery.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Functional Assessment Of Chronic Illness Therapy Head and Neck Cancer FACT HN Version4 to measure Quality of life
研究概览
简要总结
The main objective of this study is to evaluate the impact of prehabilitation on Head and Neck Cancer patients undergoing neck dissection surgery. All patients undergoing Selective Neck Dissection lymph node levels 1,2,3; Modified Radical Neck Dissection lymph node levels 1,2,3,4,5; Pectoralis Major Myocutaneous Flap will be included in the study. Patients will be recruited 3-4 weeks prior to their surgery and divided into two groups based on the computer generated randomized number. Based on the group they are in they will either be given the routine treatment which would include range of motion exercises for the neck, shoulder and mouth, postural re-education and scar mobilization techniques. Whereas the participants undergoing prehabilitation will have to undergo a 3-4 week home based program of which they have to complete a minimum of 10 sessions to continue to be part of the study. The prehabilitation intervention would include Progressive Resistance Exercise training, Stretching exercises and Aerobic exercise (Walking) ; participants would be expected to continue the same set of exercises even after their surgery once they get clearance from the surgeon. Before the commencement of any of the two exercise interventions the patients will be evaluated using the FACT H&N - Quality of life, FACIT Fatigue- Cancer related fatigue, 6 Minute Walk Test- Sub maximal Exercise Testing used to record functional capacity of the patient, the resting heart rate of the patient will be recorded and the Physical Activity Readiness Questionnaire (PARQ) will be used to check for any comorbidities. A second assessment using the same tools mentioned above will be carried out 1 day prior to their surgery. The 3rd assessment will be carried out 2-3 weeks following surgery which will include the same tools mentioned above however two new questionnaires for the evaluation of patient related outcomes for neck and shoulder disability (Neck Disability Index, Shoulder Pain And Disability Index) will be added during this phase of the assessment. Also, their duration of stay at the hospital will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients undergoing Selective Neck Dissection -1,2,3; Modified Radical Neck Dissection 1,2,3,4,5; Pectoralis Major Myocutaneous Flap European Cooperative Oncology Group (ECOG) : 0-2 Negative response to all questions from Physical Activity Readiness Questionnaire (PAR-Q) Platelet count more than 50,000 Haemoglobin more than 10.0 g/dl Absolute neutrophil count more than 0.5× 10â¹ WBC more than 5000/mm³ Hematocrit more than 25%.
排除标准
- •Patients who are unable to comprehend the instructions given to them Patients with pre-existing physical disability involving shoulder/neck Primary treatment as chemotherapy/radiotherapy Distant Metastases.
结局指标
主要结局
Functional Assessment Of Chronic Illness Therapy Head and Neck Cancer FACT HN Version4 to measure Quality of life
时间窗: FACT HN and FACIT Fatigue will be used along with 6 Minute Walk test in the assessments that will be done 3 weeks prior to surgery,once before surgery and 3 weeks after surgery | Goniometer assessment will be done 3 weeks after surgery
6 Minute Walk Test to record the Functional Capacity
时间窗: FACT HN and FACIT Fatigue will be used along with 6 Minute Walk test in the assessments that will be done 3 weeks prior to surgery,once before surgery and 3 weeks after surgery | Goniometer assessment will be done 3 weeks after surgery
Goniometer to measure Range of motion of shoulder
时间窗: FACT HN and FACIT Fatigue will be used along with 6 Minute Walk test in the assessments that will be done 3 weeks prior to surgery,once before surgery and 3 weeks after surgery | Goniometer assessment will be done 3 weeks after surgery
FACIT Fatigue scale Version 4 to evaluate Cancer related fatigue
时间窗: FACT HN and FACIT Fatigue will be used along with 6 Minute Walk test in the assessments that will be done 3 weeks prior to surgery,once before surgery and 3 weeks after surgery | Goniometer assessment will be done 3 weeks after surgery
次要结局
- Duration of stay in the hospital(Shoulder Pain And Disability Index SPADI Patient reported functional limitation)