2020-03-15
2021-07-15
2022-04-15
126
NCT04316078
Sheba Medical Center
Sheba Medical Center
INTERVENTIONAL
A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies
A randomized control trial to evaluate the feasibility of implementing a patient educational platform (PEP) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-02-23 | N/A | 2022-04-21 |
2020-03-19 | N/A | 2022-04-28 |
2020-03-20 | N/A | 2020-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Health Services Research
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: personalized engagement platform Patients registered into personalized engagement platform (PEP) will receive personalized educational videos (PEV) according to disease, treatment protocol and side effects. | OTHER: patient engagement platform
|
| NO_INTERVENTION: control group The control group will not be registered to the PEP nor receive any PEVs. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Feasibility of PEP (percent of patients using videos/complete questionnaires) | To assess the feasibility of implementing a PEP in the outpatient gastrointestinal malignancies service, at Sheba Medical Center, for patients undergoing active chemotherapy treatment. This outcome will be measured as percent of patients using the videos and percent of patients that complete the questionnaires. | 3 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Secondary clinical outcomes 1 (mean number of referrals) | To monitor mean number of referrals to emergency room and admissions to the inpatient department. | 3 years |
| Secondary clinical outcomes 2 (level of chemotoxicity) | To measure level of chemotoxicity - Neuropathy, diarrhea, nausea and vomiting, stomatitis and fever; using total number and percent of patients with side effects in each arm and Common Terminology Criteria for side effects (CTCAE) grading scale. | 3 years |
| Secondary clinical outcomes 3 (Quality of Life) | To measure patient assessment of Quality of Life (QoL) using a validated questionnaire (QLQ-C30). | 3 years |
| Secondary clinical outcomes 4 (treatment intensity and continuity) | To evaluate treatment intensity and continuity measured as number of chemotherapy cycles and cumulative chemotherapy dose. | 3 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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