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Patient EducationVIPER-RTNCT07255196

Virtual Vs Telephone Education in Radiotherapy

A study testing Videoconferencing Software for Pre-Treatment Education in people with Patient Education and Radiotherapy, run by University Health Network, Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Patient Education, Radiotherapy
What is being tested?
Videoconferencing Software for Pre-Treatment Education
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteCanada
Study dates
20 Dec 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Previous radiotherapy treatment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2C4

    Recruiting

Other trials in Canada

About this study

Official title: Virtual Vs Telephone Education in Radiotherapy - Randomized Clinical Trial

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.

Read the detailed description

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.

Being tested
Videoconferencing Software for Pre-Treatment Education
Keywords
Virutal Care, Videoconferencing, Patient Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Videoconferencing Software for Pre-Treatment EducationDevice

    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

Study groups in NCT07255196
Study groupRoleWhat they receive
Standard Care ArmNo intervention30 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 ArmActive comparator45 minute radiation therapist-led pre-treatment education with a videoconferencing call to explain upcoming radiotherapy treatment, side-effects, appointment logistics and answer patient questions
Receives: Device: Videoconferencing Software for Pre-Treatment Education

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

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

Secondary outcomes (2)
  1. Hospital Anxiety and Depression Scale (HADS-A)

    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.

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

  2. Satisfaction with Pre-Treatment Radiation Therapy Education Survey

    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.

    Measured: Delivered at T2 - exactly after CT-Simulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start20 Dec 2025
  3. Primary completionJul 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07255196
Sponsor's protocol ID
25-5883
Acronym
VIPER-RT
Status last verified
Nov 2025
First submitted
17 Nov 2025
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Videoconferencing Software for Pre-Treatment Education in people with Patient Education and Radiotherapy, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Velec, PhD (416-946-4501 ext. 4885, michael.velec@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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