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.
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
- Recruiting
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2C4
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.
- Conditions
- Patient Education, Radiotherapy
- 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 group | Role | What they receive |
|---|---|---|
| Standard Care Arm | No intervention | 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 | Active comparator | 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 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.
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)
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
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.
- First posted28 Nov 2025
- Study start20 Dec 2025
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EducationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Velec, University Health Network, Toronto
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Vs Telephone Education in Radiotherapy - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07255196
- Acronym / sponsor ID
- VIPER-RT / 25-5883
- Conditions
- Patient Education, Radiotherapy
- Keywords
- Virutal Care, Videoconferencing, Patient Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Arm | No intervention | –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 | Active comparator | Device: Videoconferencing Software for Pre-Treatment Education45 minute radiation therapist-led pre-treatment education with a videoconferencing call to explain upcoming radiotherapy treatment, side-effects, appointment logistics and answer patient questions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Previous radiotherapy treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videoconferencing Software for Pre-Treatment EducationVideoconferencing 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 | Device | Videoconferencing Arm |
Primary outcome
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
2 secondary outcomes
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
Satisfaction with Pre-Treatment Radiation Therapy Education Survey
Time frame: Delivered at T2 - exactly after CT-Simulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.