A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies

April 21, 2022 updated by: Sheba Medical Center

A Novel Patient Engagement Platform Used to Improve Understanding, Treatment Compliance and Quality of Care 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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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
  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.
No Intervention: control group
The control group will not be registered to the PEP nor receive any PEVs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of PEP (percent of patients using videos/complete questionnaires)
Time Frame: 3 years
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

Outcome Measure
Measure Description
Time Frame
Secondary clinical outcomes 1 (mean number of referrals)
Time Frame: 3 years
To monitor mean number of referrals to emergency room and admissions to the inpatient department.
3 years
Secondary clinical outcomes 2 (level of chemotoxicity)
Time Frame: 3 years
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)
Time Frame: 3 years
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)
Time Frame: 3 years
To evaluate treatment intensity and continuity measured as number of chemotherapy cycles and cumulative chemotherapy dose.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Ofer Margali, MD PhD, Sheba Medical Center

Study record dates

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 Major Dates

Study Start (Actual)

March 15, 2020

Primary Completion (Actual)

July 15, 2021

Study Completion (Actual)

April 15, 2022

Study Registration Dates

First Submitted

February 23, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-19-6013-YL-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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