A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cholangiocarcinoma
- Colon Cancer
- Esophageal Cancer
- Gastric Cancer
- Pancreas Cancer
- Rectal Cancer
- Small Bowel Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized control study (1:1 allocation)Masking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
Patients will be randomized in a 1:1 ratio by the last digit of the patient's identification number, where odd numbers will be assigned to the control group (receiving standard of care follow-up) and even numbers will be assigned to the experimental group. Patients in the experimental arm will recei...
Patients will be randomized in a 1:1 ratio by the last digit of the patient's identification number, where odd numbers will be assigned to the control group (receiving standard of care follow-up) and even numbers will be assigned to the experimental group. 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 2 weeks 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.
Tracking Information
- NCT #
- NCT04316078
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ofer Margali, MD PhD Sheba Medical Center