Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07255196

Virtual Vs Telephone Education in Radiotherapy

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2C4, Canada

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Previous radiotherapy treatment

Treatment and study plan

Videoconferencing Software for Pre-Treatment Education

Device

Videoconferencing software used for pre-treatment education with face-to-face, patient-to-provider communication using a slide deck with images to help with pre-treatment educational material for radiotherapy

Primary outcomes

  1. Cancer Treatment Survey Procedural Fears & Concerns Subscale (CaTS-PC)

    Time frame: 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

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS-A)

    Time frame: Measured at three time points (T1-T3). T1: Baseline, T2: exactly after patient CT-Simulation and T3: exactly after patient first day of radiotherapy

    7 question survey measured on a 4 point scale (0-3). Total scores are summed and give a indication of patient anxiety levels at the time of completion based. Scores are divided as follows: 0-7 is considered normal, 8-10 is borderline or mild anxiety, and 11-21 is considered severe.

  2. Satisfaction with Pre-Treatment Radiation Therapy Education Survey

    Time frame: Delivered at T2 - exactly after CT-Simulation

    6 likert scale question survey looking at patients overall satisfaction with the specific modality used for pre-treatment education. Looking at the overall appointment, as well as the informational needs of patients. Each question will be looked at individually.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Velec, PhD

CONTACT

[email protected]

416-946-4501 ext. 4885

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Virtual Vs Telephone Education in Radiotherapy - Randomized Clinical Trial

Acronym: VIPER-RT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.