Clinical trial · Interventional
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
NCT04316078CI-TRIAL-00058114completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A randomized control trial to evaluate the feasibility of implementing a patient educational platform (PEP) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Small Bowel Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| patient engagement platform | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- personalized engagement platform
- description
- Patients registered into personalized engagement platform (PEP) will receive personalized educational videos (PEV) according to disease, treatment protocol and side effects.
- interventionNames
- Other: patient engagement platform
- type
- NO_INTERVENTION
- label
- control group
- description
- The control group will not be registered to the PEP nor receive any PEVs.
Primary outcomes (1)
- measure
- Feasibility of PEP (percent of patients using videos/complete questionnaires)
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Individuals with a newly diagnosed gastrointestinal malignancy, treated at the outpatient clinic of the Institute of Oncology at the Sheba Medical Center 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: 1. Eastern Conference Oncology Group (ECOG) performance status greater than 2. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.