跳至主要内容
临床试验/CTRI/2024/02/062366
CTRI/2024/02/062366已完成不适用

Effectiveness of a Multimodal Oncology Rehabilitation Exercise Program (MORE) on the Cognitive, Physical and Psychosocial Domains of Head and Neck Cancer Survivors Undergoing Chemoradiotherapy (CRT) in a tertiary care hospital in Dakshina Kannada district.

Department of Physiotherapy1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年3月6日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1
主要终点
(Patient Health Questionnaire) PHQ – 4 scale

研究概览

简要总结

The study aims to determine the effectiveness of integrating an 8-week Multimodal Oncology Rehabilitation Exercise (MORE) program on the cognitive, physical and psychosocial outcomes of HNC survivors undergoing chemoradiotherapy (CRT) in tertiary care hospital in Dakshina Kannasa district. In addition, this study also aims to evaluate the effectiveness of an integrated 8 week MORE program domain as well as the overall QOL of HNC survivors. Furthermore, to evaluate the efficacy of the MORE program on the physical parameters i.e., functional capacity and muscle strength among the survivors.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • a)Histologically proven primary diagnosis of HNC.
  • TNM stages III, IVA and IVB b)Age 18 years to 100 years c)Patients planned for definitive chemoradiotherapy (CRT) d)Clearance from the attending physician (Radiation Oncologist) e)Eastern Cooperative Oncology Group (ECOG) score 0-2.

排除标准

  • a)Patients with reduced alertness b)Patients with non-ambulatory status c)Any distant metastases d)Any medical complication limiting participation in exercise e)Significant cardiac, respiratory, neurologic or orthopaedic conditions that could influence the successful completion of the exercise regime.

结局指标

主要结局

(Patient Health Questionnaire) PHQ – 4 scale

时间窗: Baseline | Week 4 | Week 8 | 3rd Month (Follow-up)

次要结局

  • 1. Functional Assessment of Cancer therapy – Cognitive Function (FACT-Cog) version 3 scale(2. The 6 – Minute Walk Test (6MWT) distance)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Hritika Pai

Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India.

研究点 (1)

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