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临床试验/CTRI/2024/09/073331
CTRI/2024/09/073331尚未招募1 期

Effectiveness of Video-Based Education Program On Post-Radiotherapy Side-Effects Among Patients With Head and Neck Cancer in a Tertiary Care Center: A Quasi-Experimental Study

All India Institute of Medical Sciences, Jodhpur1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
Post-radiotherapy side effects: fatigue, weight loss, dysphagia, xerostomia, nausea and vomiting, oral mucositis, radiation dermatitis

研究概览

简要总结

Aim of the study

This study aims to assess the effectiveness of of video-based educational programs on post-radiotherapy side effects and to determine its association with selected socio-demographic and clinical variables.

Objectives

1)     To assess and compare the effectiveness of a video-based education program on selected post-radiotherapy side effects among patients with head and neck cancer receiving radiotherapy.

 2)     To determine the association of selected post-radiotherapy side effects with selected socio-demographic and clinical variables.

Hypotheses

H01- There will be no significant difference in the post-radiotherapy side effects in experimental and control groups after the administration of video-based education.

H02**-** There will be no significant association of post-radiotherapy side effects and patients with head and neck cancers with selected sociodemographic variables.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with head and neck cancer who are more than 18 years old and attending the Oncology Day Care OPD of AIIMS, Jodhpur.
  • Patients with head and neck cancer attending the Oncology Day Care OPD of AIIMS, Jodhpur, to receive radiotherapy, adjuvant radiotherapy, or neo-adjuvant radiotherapy for the first time.

排除标准

  • Patients who are not able to follow instructions.
  • Patients who are not willing to participate.

结局指标

主要结局

Post-radiotherapy side effects: fatigue, weight loss, dysphagia, xerostomia, nausea and vomiting, oral mucositis, radiation dermatitis

时间窗: The post-radiotherapy side effects will be measured at 3 points in time: | Baseline data will be collected at the time of enrolment | Assessment I: One week after receiving the first radiotherapy | Assessment II- At the end of the first month (4 weeks). | Assessment III- At the end of 6 weeks.

次要结局

  • Association of selected post-radiotherapy side effects with selected socio-demographic and clinical variables.(Sociodemographic and clinical data will be collected at the time of enrolment)

研究者

发起方
All India Institute of Medical Sciences, Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Riya Pan

All India Institute of Medical Sciences Jodhpur

研究点 (1)

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