A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies
NCT ID: NCT04316078
Last Updated: 2022-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2020-03-15
2022-04-15
Brief Summary
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Detailed Description
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Patients in the experimental arm will receive automatically generated personalized educational videos (PEV) and questionnaires regarding side effects and quality of life (QOL) to either their cell phone or email. The videos will be personalized to each patient based on their demographics, specific medical instructions and treatment plan. Data collected regarding side effects and QOL in the experimental arm will be used in order to facilitate real time intervention through real time provider alert system.
A link to the first PEV will be sent before the first chemotherapy cycle, addressing the diagnosis and type of malignancy, chemotherapy protocol, common side effects and their management. Side effects questionnaire will be sent every week while QOL questionnaire will be sent every 6 weeks.
Patients will be followed from recruitment through three weeks after completion of the planned treatment protocol. If treatment is discontinued prior to completion of the protocol, follow-up will end three weeks after the last administered treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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personalized engagement platform
Patients registered into personalized engagement platform (PEP) will receive personalized educational videos (PEV) according to disease, treatment protocol and side effects.
patient engagement platform
1. Allows patients to receive the action plan as educational videos on demand.
2. Allows patients to report side effects and quality of life via questionnaires and receive immediate targeted education based on the predefined action plan.
control group
The control group will not be registered to the PEP nor receive any PEVs.
No interventions assigned to this group
Interventions
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patient engagement platform
1. Allows patients to receive the action plan as educational videos on demand.
2. Allows patients to report side effects and quality of life via questionnaires and receive immediate targeted education based on the predefined action plan.
Eligibility Criteria
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Inclusion Criteria
2. Individuals planned to receive one of the following cytotoxic chemotherapy protocols:
1. FOLFOX - a combination of 5-fluoruracil, leucovorin and oxaliplatin.
2. FOLFOIRI - a combination of 5-fluoruracil, leucovorin and irinotecan.
3. FOLFIRINOX - a combination of 5-fluoruracil, leucovorin, oxaliplatin and irinotecan.
4. De Gramont - 5-fluoruracil and leucovorin.
3. Ability to read and comprehend Hebrew language text.
4. Ability to see computer or cell phone screen (i.e., no visual impairment).
Exclusion Criteria
2. Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
3. Inability to read and comprehend Hebrew language text.
4. Current participation in a therapeutic clinical trial.
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Ofer Margali, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Sheba Medical Center
Ramat Gan, , Israel
Countries
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Other Identifiers
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SHEBA-19-6013-YL-CTIL
Identifier Type: -
Identifier Source: org_study_id
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