Status:
COMPLETED
A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies
Lead Sponsor:
Sheba Medical Center
Conditions:
Colon Cancer
Gastric Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
A randomized control trial to evaluate the feasibility of implementing a patient educational platform (PEP) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment.
Detailed Description
Patients will be randomized in a 2:1 ratio. Patients in the experimental arm will receive automatically generated personalized educational videos (PEV) and questionnaires regarding side effects and q...
Eligibility Criteria
Inclusion
- Individuals with a newly diagnosed gastrointestinal malignancy, treated at the outpatient clinic of the Institute of Oncology at the Sheba Medical Center
- Individuals planned to receive one of the following cytotoxic chemotherapy protocols:
- FOLFOX - a combination of 5-fluoruracil, leucovorin and oxaliplatin.
- FOLFOIRI - a combination of 5-fluoruracil, leucovorin and irinotecan.
- FOLFIRINOX - a combination of 5-fluoruracil, leucovorin, oxaliplatin and irinotecan.
- De Gramont - 5-fluoruracil and leucovorin.
- Ability to read and comprehend Hebrew language text.
- Ability to see computer or cell phone screen (i.e., no visual impairment).
Exclusion
- Eastern Conference Oncology Group (ECOG) performance status greater than 2.
- Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
- Inability to read and comprehend Hebrew language text.
- Current participation in a therapeutic clinical trial.
Key Trial Info
Start Date :
March 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2022
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04316078
Start Date
March 15 2020
End Date
April 15 2022
Last Update
April 28 2022
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel, 52621