Clinical trial NCT04316078: A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies
Official title: A Novel Patient Engagement Platform Used to Improve Understanding, Treatment Compliance and Quality of Care Among Patients With Gastrointestinal Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Gastric Cancer
Pancreas Cancer
Rectal Cancer
Cholangiocarcinoma
Small Bowel Cancer
Esophageal Cancer
Keywords: patient reported outcome
quality of life
personalized videos
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-03-20
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control study (2:1 allocation)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of PEP (percent of patients using videos/complete questionnaires)
timeFrame: 3 years
Secondary outcomes:
measure: Secondary clinical outcomes 1 (mean number of referrals)
timeFrame: 3 years
measure: Secondary clinical outcomes 2 (level of chemotoxicity)
timeFrame: 3 years
measure: Secondary clinical outcomes 3 (Quality of Life)
timeFrame: 3 years
measure: Secondary clinical outcomes 4 (treatment intensity and continuity)
timeFrame: 3 years
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Ofer Margali, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: