Comparative Effectiveness of Verbal Instruction Versus Simulation Video Education Among Cancer Patients Undergoing Radiation Therapy in Lower Middle Income Country Centre: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ''Change in Patient-Reported Understanding of Radiation Therapy Between Pre- and Post-Consultation Assessments''
研究概览
简要总结
The goal of this Randomized Controlled Trial is to compare the effectiveness of radiotherapy-specific, physician-led educational videos introduced before the initial Radiation Therapy consultation .
The primary objective is to assess the impact on patient-reported knowledge of RT, with secondary objectives including assessment of patient-reported anxiety and satisfaction with the educational process.
Patients will be randomly assigned to two groups.
- Video Group - Patients will receive a WhatsApp message containing the educational video prior to their consultation.
- Verbal Instruction Group - Patients will receive standard verbal education from a radiation oncologist during their consultation.
The participants will fill Pre and post intervention questionnaire forms
详细描述
The stress and fatigue associated with cancer treatment are significant concerns that can greatly affect a patient's quality of life. Few studies discussed how common and debilitating cancer-related fatigue can be, highlighting the need for better educational tools to help patients manage their treatment and its side effects. Providing clear, engaging information through videos could help reduce anxiety and make the treatment process less overwhelming for patients.
This study aims to evaluate the effectiveness of radiotherapy-specific, physician-led educational videos introduced before the initial RT consultation. The primary objective is to assess the impact on patient-reported knowledge of RT, with secondary objectives including assessment of patient-reported anxiety and satisfaction with the educational process. Through this approach, we aim to contribute to emerging strategies that optimize patient preparedness and emotional well-being in radiation oncology
Video Development
A single educational video was developed to provide a general overview of radiation therapy for cancer patients undergoing treatment at the Cyber Knife and Tomotherapy Centre, JPMC. The video was designed to enhance patient understanding of the radiation treatment process, and reduce anxiety The volunteers of the student led forum Tumor Board Establishment Facilitation Forum (TEFF), were approached to direct, organize, and film the video. The content of video was developed by a team of radiation oncology from Pakistan and Canada. The video was created in Urdu, the native language of Pakistan, ensuring accessibility for a broad patient population. It was approximately 3.5 minutes long. The editing process was iterative, involving multiple draft scripts and a trial video. Feedback on content, style, and delivery was gathered from all stakeholders before finalizing the videos. The video was assessed using the Patient Education Materials Assessment Tool for Audiovisual Materials (PEMAT-A/V), scoring 100% on understandability and 100% on action ability.
Physicians, resident medical officers, and departmental staff participated in the video, each signing a Consent to Photograph release form. The videos include sections on overview, simulation, treatment, side effects, and post-treatment follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cancer and scheduled for radiation therapy at Tomotherapy unit of Cyber knife and Tomotherapy Centre of JPMC.
- •Fluent in Urdu.
- •No prior experience with radiation therapy.
- •Must have smart phone
排除标准
- •Patients who either refused consent or were ineligible based on the study's inclusion criteria.
研究组 & 干预措施
Video Group
Patients will receive a WhatsApp message containing the educational video prior to their consultation.
干预措施: Radiotherapy-Specific Educational Video (Behavioral)
Verbal Instruction Group
Patients will receive a standard verbal education from a radiation oncologist during their consultation.
结局指标
主要结局
''Change in Patient-Reported Understanding of Radiation Therapy Between Pre- and Post-Consultation Assessments''
时间窗: Baseline and immediately post- educational intervention (same-day assessment)
The primary outcome of this study is the change in patient-reported knowledge and understanding of radiation therapy (RT) following exposure to educational intervention. This outcome is measured by comparing pre- and post-consultation knowledge and understanding scores between the two study arms (video education vs. verbal instruction) using a self-administered 5-point Likert questionnaire (1 = very poor, 5 = excellent). Higher scores indicate better understanding. Anxiety is measured on a 10-point Visual Analog Scale (0 = no anxiety, 10 = maximum), with higher scores indicating worse anxiety. The questionnaire evaluates patient understanding across key domains of the radiation therapy process, including RT purpose and goals, simulation and immobilization, treatment delivery, expected side effects, and follow-up. The primary endpoint is the mean change in composite knowledge score from baseline to post-consultation, with greater improvement indicating better understanding.
次要结局
未报告次要终点
研究者
Fatima Shaukat
Consultant Radiation Oncologist
Jinnah Postgraduate Medical Centre