Cancer (Solid Tumors)CARE-RTNCT07367997
Comparative Effectiveness of Verbal Instruction Versus Simulation Video Education Among Cancer Patients Undergoing Radiation Therapy
A study testing Radiotherapy-Specific Educational Video in people with Cancer (Solid Tumors) and Cancer and / or Hematological Malignancy, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
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 . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer (Solid Tumors), Cancer and / or Hematological Malignancy
- What is being tested?
- Radiotherapy-Specific Educational Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who either refused consent or were ineligible based on the study's inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Radiation Oncology, Cyberknife and Tomotherapy Center, Jinnah Postgraduate Medical Centre (JPMC), Karachi, Pakistan Karachi, Pakistan
Karachi, 75510
About this study
Official title: 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.
Read more
Patients will be randomly assigned to two groups.
- Video Group - Patients will receive a WhatsApp message containing the educational video prior to their consultation.
- 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
Read the 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:
- Video Group - Patients will receive a WhatsApp message containing the educational video prior to their consultation.
- 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:
- 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.
- 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.
- Being tested
- Radiotherapy-Specific Educational Video
- Keywords
- Radiation Education
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy-Specific Educational VideoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video Group | Experimental | Patients will receive a WhatsApp message containing the educational video prior to their consultation. Receives: Behavioral: Radiotherapy-Specific Educational Video |
| Verbal Instruction Group | No intervention | Patients will receive a standard verbal education from a radiation oncologist during their consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
''Change in Patient-Reported Understanding of Radiation Therapy Between Pre- and Post-Consultation Assessments''
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.
Measured: Baseline and immediately post- educational intervention (same-day assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer (Solid Tumors)Studies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatima Shaukat, Jinnah Postgraduate Medical Centre
- Investigators
- Fatima Shaukat, MBBS, FCPS, Principal investigator, Patients Aid Foundation, JPMCYUMNA AHMED, MBBS, FCPS, Study director, Patients Aid Foundation, JPMCRabia Tahseen, MBBS, FCPS, Study chair, Patients Aid Foundation, JPMCAgha Muhammad Hammad Khan, MBBS, FCPS, Study director, Ziauddin university Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367997
- Sponsor's protocol ID
- NO.F.2-81/2024-GENL/94/JPMC
- Acronym
- CARE-RT
- Status last verified
- Aug 2026
- First submitted
- 1 Jan 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07367997
- Acronym / sponsor ID
- CARE-RT / NO.F.2-81/2024-GENL/94/JPMC
- Keywords
- Radiation Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 26 Jan 2026 (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 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.
- Video Group - Patients will receive a WhatsApp message containing the educational video prior to their consultation.
- 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
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:
- Video Group - Patients will receive a WhatsApp message containing the educational video prior to their consultation.
- 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:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Group | Experimental | Behavioral: Radiotherapy-Specific Educational VideoPatients will receive a WhatsApp message containing the educational video prior to their consultation. |
| Verbal Instruction Group | No intervention | –Patients will receive a standard verbal education from a radiation oncologist during their consultation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who either refused consent or were ineligible based on the study's inclusion criteria.
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 |
|---|---|---|
| Radiotherapy-Specific Educational VideoThis 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. | Behavioural | Video Group |
Primary outcome
''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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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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. This study is not recruiting at the moment.
Fatima Shaukat, MBBS, FCPS principal investigator
Patients Aid Foundation, JPMC
YUMNA AHMED, MBBS, FCPS study director
Patients Aid Foundation, JPMC
Rabia Tahseen, MBBS, FCPS study chair
Patients Aid Foundation, JPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy-Specific Educational Video in people with Cancer (Solid Tumors) and Cancer and / or Hematological Malignancy, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 25 Aug 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
''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)). 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 25 Aug 2026.