- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06805773
Evaluating the Use of Educational Videos in Newly Diagnosed Patients in a Medical Oncology Sarcoma Clinic
Evaluating the Use of Educational Videos in a Medical Oncology Sarcoma Clinic to Improve Patient Knowledge and Satisfaction.
This study aims to evaluate how sarcoma-specific educational videos improve patients' knowledge of their disease and treatment options before their first clinic appointment.
Participants will watch four educational videos before their first appointment with a medical oncologist. Participants will be asked to complete surveys to assess their understanding of sarcoma and its treatment options before and after their first medical oncology clinic appointment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clinical Trials Manager
- Phone Number: 416-586-8440
- Email: Oncology.Research@sinaihealth.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Recruiting
- Mount Sinai Hospital
-
Contact:
- Clinical Trials Manager
- Phone Number: 4165868440
- Email: Oncology.Research@sinaihealth.ca
-
Principal Investigator:
- Geoffrey Watson
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Signed written and voluntary informed consent.
- Have histologically documented advanced metastatic sarcoma, or is a caregiver of a patient with histologically documented advanced metastatic sarcoma.
- Age ≥ 18 years.
- Have not received any previous systemic treatment for sarcoma, or is a caregiver of a sarcoma patient who has not received any previous systemic treatment for sarcoma.
- Willing/able to complete questionnaires.
- Able to read and write in English.
Exclusion Criteria:
- Inability to provide informed consent.
- Previously seen by a medical oncologist for their sarcoma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Standard of Care
|
Participants in the control arm will be provided with the educational videos after their consult with the medical oncologist.
|
|
Experimental: Educational Videos
|
Participants will be provided with four educational videos in clinic prior to their initial medical oncology consult.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess differences in patients' and caregivers' knowledge and perceptions of sarcoma and its treatment before and after educational intervention
Time Frame: up to 2 weeks (date when given appointment and date of first appointment)
|
Evaluate the changes in global responses between baseline surveys and post educational intervention surveys.
|
up to 2 weeks (date when given appointment and date of first appointment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess understandability and actionability of sarcoma educational videos.
Time Frame: up to 2 weeks (date when given appointment and date of first appointment)
|
The Patient Education Materials Assessment Tool (PEMAT) for Audiovisual Materials will be used to assess the video's understandability and actionability.
The higher the score (>80%), the more understandable or actionable the material.
|
up to 2 weeks (date when given appointment and date of first appointment)
|
|
Assess understandability and actionability of sarcoma educational videos.
Time Frame: up to 2 weeks (date when given appointment and date of first appointment)
|
The Suitability Assessment of Materials (SAM) will be used for evaluation of health-related information for adults to objectively assess the suitability of these educational materials for sarcoma patients.
|
up to 2 weeks (date when given appointment and date of first appointment)
|
|
Assess patient's and caregivers' satisfaction with the educational videos
Time Frame: up to 2 weeks (date when given appointment and date of first appointment)
|
Based on responses from a post-educational intervention survey.
The scores will be measured using a Likert Scale (1-5), with higher scores indicating greater satisfaction.
|
up to 2 weeks (date when given appointment and date of first appointment)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4693
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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