A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies

Sheba Medical Center

Status: Completed

Conditions: Esophageal Cancer; Gastric Cancer; Colon Cancer; Pancreas Cancer; Cholangiocarcinoma; Small Bowel Cancer; Rectal Cancer

Treatments: Other: patient engagement platform

Study type: Interventional

Funder types: Other

Identifiers

NCT04316078

SHEBA-19-6013-YL-CTIL

Details and patient eligibility

About

A randomized control trial to evaluate the feasibility of implementing a patient educational platform (PEP) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment.

Full 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.

Enrollment: 126 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

personalized engagement platform

Experimental group

Description:

Patients registered into personalized engagement platform (PEP) will receive personalized educational videos (PEV) according to disease, treatment protocol and side effects.

Treatment:

Other: patient engagement platform

control group

No Intervention group

Description:

The control group will not be registered to the PEP nor receive any PEVs.