Virtual Vs Telephone Education in Radiotherapy - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Cancer Treatment Survey Procedural Fears & Concerns Subscale (CaTS-PC)
研究概览
简要总结
The goal of this clinical trial is to compare whether the use of videoconferencing in breast cancer patients undergoing radiotherapy is better for pre-treatment education than telephone calls. The main question it aims to answer is in breast cancer patient receiving radiotherapy, does videoconferencing, compared to telephone calls for pre-treatment education result in decreased procedural fears and concerns? The investigators hypothesize that the use of videoconferencing for pre-treatment radiotherapy education will decrease breast cancer patients' procedural fears and concerns. Researchers will compare the current standard of care in a 30 minute radiation therapist led pre-treatment education call to the intervention of a 45 minute radiation therapist led videoconferencing call to see if the intervention reduces patient procedural fears and concerns, anxiety levels, and has higher patient satisfaction. Participants will be asked to complete questionnaires at three time points: 1. Baseline - at time of study consent. 2. CT-Simulation - after their radiotherapy CT-Simulation appointment. 3. Day 1 Treatment - after their first day of radiotherapy treatment.
详细描述
Rationale: Breast cancer (BC) is a major health concern worldwide. In 2024, it was stated that breast cancer makes up almost 25% of all new cancer diagnoses in women. Breast cancer was also found to be the leading cause of cancer death in women. The use of Radiation Therapy (RT) plays a major role in the treatment of breast cancer. Although RT has such a large role, the complexity of RT can be psychologically and physically demanding for patients. Many patients require and seek out a large amount of information to help facilitate understanding of RT. Evidence suggests the use of a pre-treatment education session led by a Radiation Therapist(s) has been found to reduce patients' procedural fears, concerns and overall anxiety levels. Since the COVID-19 pandemic, telephone calls became the standard for pre-treatment education. Recently a study by Magliozzi et al has found the use of videoconferencing-based education demonstrated higher levels of patient satisfaction and preference over telephone. However, evidence directly comparing these two modalities against each other is lacking.
Objective
The aim of this study is comparing the effectiveness of the current standard in pre-RT education using telephone calls versus videoconferencing led education in reducing breast cancer patients' procedural fears and concerns related to RT. The investigators hypothesize that the use of videoconferencing will decrease breast cancer patients' procedural concerns more than using telephone calls. If videoconferencing does reduce breast cancer patients' procedural fears and concerns, future directions for radiation therapy education will be to implement videoconferencing as the current standard for breast cancer patients, and eventually all patients. In addition to this, cancer centers worldwide will be able to implement a virtual approach if the cancer center has the resources to do such.
Experimental Approach: To test this hypothesis, the experimental approach is a prospective randomized clinical trial of Radiation Therapist-led patient education sessions comparing the two modalities, videoconferencing and telephone. Breast cancer patients receiving radical breast radiotherapy above the age of 18 and have a device with access to the internet and Microsoft Teams will be consented and randomized 1:1 into the intervention group (videoconferencing) or control group (telephone). The primary endpoint for this study is a change in patients' procedural fears and concerns using the Cancer Treatment Survey (CaTS). A total sample size of 130 patients, measured at 3 time points (T1: baseline, T2: post CT-Simulation, and T3: post day 1 treatment), will achieve 80% power at a 0.05 significance level to detect a mean difference of 0.44 in the CaTS procedural fears and concerns subscale between groups using a repeated measures design. Secondary endpoints for this study include patient reported anxiety levels measured by the Hospital Anxiety and Depression Scale, anxiety subscale (HADS-A), and overall patient satisfaction measured using a survey adapted from Berlin et al. Anxiety levels will be measured at all three time points, whereas satisfaction will be measured at T2 due to its close timing with the education session.
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
- 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
- •18 years or older
- •Access to an internet connected device with a microphone and camera
- •Able to communicate in English with/without a translator
- •Receiving radical breast cancer radiotherapy
排除标准
- •Previous radiotherapy treatment
研究组 & 干预措施
Standard Care Arm
30 minute radiation therapist-led pre-treatment education with a telephone call to explain upcoming radiotherapy treatment, side-effects, appointment logistics and answer patient questions
Videoconferencing Arm
45 minute radiation therapist-led pre-treatment education with a videoconferencing call to explain upcoming radiotherapy treatment, side-effects, appointment logistics and answer patient questions
干预措施: Videoconferencing Software for Pre-Treatment Education (Device)
结局指标
主要结局
Cancer Treatment Survey Procedural Fears & Concerns Subscale (CaTS-PC)
时间窗: Measured at three time points (T1-T3). T1: Baseline, T2: exactly after patient CT-Simulation and T3: exactly after patient first day of radiotherapy
11 total questions relating to patients procedural fears and concerns on a Likert-scale (1-5), mean scores are taken from this to generate a procedural fear and concern level out of 5, with lower scores indicating less procedural fears and concerns
次要结局
- Hospital Anxiety and Depression Scale (HADS-A)(Measured at three time points (T1-T3). T1: Baseline, T2: exactly after patient CT-Simulation and T3: exactly after patient first day of radiotherapy)
- Satisfaction with Pre-Treatment Radiation Therapy Education Survey(Delivered at T2 - exactly after CT-Simulation)
研究者
Michael Velec
Clinician Scientist - Radiation Therapist
University Health Network, Toronto