Comparative Effectiveness of Verbal Instruction Versus Simulation Video Education Among Cancer Patients Undergoing Radiation Therapy (CARE-RT)

January 20, 2026 updated by: Fatima Shaukat, Jinnah Postgraduate Medical Centre

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

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.

  1. Video Group - Patients will receive a WhatsApp message containing the educational video prior to their consultation.
  2. 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Design This is a Phase 2, single-center, randomized controlled trial (RCT) designed to compare the effectiveness of verbal instruction versus simulation video education among cancer patients undergoing radiation therapy. The study will be conducted at JPMC's Cyber Knife and Tomotherapy Centre, a specialized facility providing cost-free radiation therapy services in Karachi, Pakistan 100 Patients will be randomly assigned to two groups. Randomization will be performed using an online randomization tool (www.randomizer.org) at a 1:1 ratio:

  1. Video Group - Patients will receive a WhatsApp message containing the educational video prior to their consultation.
  2. Verbal Instruction Group - Patients will receive a standard verbal education from a radiation oncologist during their consultation.

Educational videos specific to our department or physicians are not previously available. Patients scheduled for a simulation, who agree to participate will be sent either to video group or verbal instruction group as per randomization Participants

Patients will be recruited in a span of 6 months. Eligible participants meet the following criteria:

  • 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 All patients will be offered to participate. Those who did not consent will be excluded.

Outcome Measures

Primary and secondary outcomes will be assessed using validated patient-reported surveys at two time points:

  1. Pre-consultation survey - Administered before the radiation oncology consultation to assess baseline patient reported understanding, knowledge and expectations for RT simulation process. It also assesses anxiety and fear related to radiation treatment.
  2. Post-consultation survey - Administered after the consultation to measure improvement in understanding, treatment confidence, and satisfaction.

Responses will be collected on a 5-point Likert scale, and comparisons between the two groups will be analyzed to determine the impact of video education versus verbal instruction.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

Patients who either refused consent or were ineligible based on the study's inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Video Group
Patients will receive a WhatsApp message containing the educational video prior to their consultation.
Behavioral: Radiotherapy-Specific Educational Video

This intervention consists of a radiotherapy-specific, physician-led educational video delivered prior to the first radiation oncology consultation. The video was locally developed, filmed within the actual CyberKnife and Tomotherapy facility, and features real radiation oncologists, residents, and departmental staff familiar to patients. It demonstrates real simulation rooms, immobilization devices, and treatment machines that patients will encounter during their care.

The video is 3.5 minutes in duration, delivered in Urdu, the native language of the study population, and specifically designed for radiation therapy-naïve patients in a lower-middle-income country setting. Content includes an overview of radiation therapy, simulation procedures, treatment delivery, common side effects, and post-treatment follow-up.
No Intervention: Verbal Instruction Group
Patients will receive a standard verbal education from a radiation oncologist during their consultation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
''Change in Patient-Reported Understanding of Radiation Therapy Between Pre- and Post-Consultation Assessments''
Time Frame: 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.
Baseline and immediately post- educational intervention (same-day assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jinnah Postgraduate Medical Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fatima Shaukat, MBBS, FCPS, Patients Aid Foundation, JPMC
  • Study Director: YUMNA AHMED, MBBS, FCPS, Patients Aid Foundation, JPMC
  • Study Chair: Rabia Tahseen, MBBS, FCPS, Patients Aid Foundation, JPMC
  • Study Director: Agha Muhammad Hammad Khan, MBBS, FCPS, Ziauddin university Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NO.F.2-81/2024-GENL/94/JPMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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