Trials / Completed
CompletedNCT04316078
A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies
A Novel Patient Engagement Platform Used to Improve Understanding, Treatment Compliance and Quality of Care Among Patients With Gastrointestinal Malignancies
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 126 (actual)
- Sponsor
- Sheba Medical Center · Other Government
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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 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
- Colon Cancer
- Gastric Cancer
- Pancreas Cancer
- Rectal Cancer
- Cholangiocarcinoma
- Small Bowel Cancer
- Esophageal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
Timeline
- Start date
- 2020-03-15
- Primary completion
- 2021-07-15
- Completion
- 2022-04-15
- First posted
- 2020-03-20
- Last updated
- 2022-04-28
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT04316078. Inclusion in this directory is not an endorsement.