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

Jinnah Postgraduate Medical Centre

Status: Not yet enrolling

Conditions: Cancer and / or Hematological Malignancy; Cancer (Solid Tumors)

Treatments: Behavioral: Radiotherapy-Specific Educational Video

Study type: Interventional

Funder types: Other

Identifiers

NCT07367997

NO.F.2-81/2024-GENL/94/JPMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Video Group

Experimental group

Description:

Patients will receive a WhatsApp message containing the educational video prior to their consultation.

Treatment:

Behavioral: Radiotherapy-Specific Educational Video

Verbal Instruction Group

No Intervention group

Description:

Patients will receive a standard verbal education from a radiation oncologist during their consultation.