NCT04316078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

March 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

April 28, 2022

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

February 23, 2020

Last Update Submit

April 21, 2022

Conditions

Colon CancerGastric CancerPancreas CancerRectal CancerCholangiocarcinomaSmall Bowel CancerEsophageal Cancer

Keywords

patient reported outcomequality of lifepersonalized videos

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Secondary clinical outcomes 1 (mean number of referrals)

    3 years

  • Secondary clinical outcomes 2 (level of chemotoxicity)

    3 years

  • Secondary clinical outcomes 3 (Quality of Life)

    3 years

  • Secondary clinical outcomes 4 (treatment intensity and continuity)

    3 years

Study Arms (2)

personalized engagement platform

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

patient engagement platformOTHER

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.

personalized engagement platform

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with a newly diagnosed gastrointestinal malignancy, treated at the outpatient clinic of the Institute of Oncology at the Sheba Medical Center
  • Individuals planned to receive one of the following cytotoxic chemotherapy protocols:
  • FOLFOX - a combination of 5-fluoruracil, leucovorin and oxaliplatin.
  • FOLFOIRI - a combination of 5-fluoruracil, leucovorin and irinotecan.
  • FOLFIRINOX - a combination of 5-fluoruracil, leucovorin, oxaliplatin and irinotecan.
  • De Gramont - 5-fluoruracil and leucovorin.
  • Ability to read and comprehend Hebrew language text.
  • Ability to see computer or cell phone screen (i.e., no visual impairment).

You may not qualify if:

  • Eastern Conference Oncology Group (ECOG) performance status greater than 2.
  • Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
  • Inability to read and comprehend Hebrew language text.
  • Current participation in a therapeutic clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Colonic NeoplasmsStomach NeoplasmsPancreatic NeoplasmsRectal NeoplasmsCholangiocarcinomaEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesRectal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeHead and Neck NeoplasmsEsophageal Diseases

Study Officials

  • Ofer Margali, MD PhD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized control study (2:1 allocation)
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2020

First Posted

March 20, 2020

Study Start

March 15, 2020

Primary Completion

July 15, 2021

Study Completion

April 15, 2022

Last Updated

April 28, 2022

Record last verified: 2020-03

Locations

IL(1)