Back to resultsA Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies
Primary Purpose
Colon Cancer, Gastric Cancer, Pancreas Cancer
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
patient engagement platform
Sponsored by
About this trial
This is an interventional health services research trial for Colon Cancer focused on measuring patient reported outcome, quality of life, personalized videos
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
personalized engagement platform
control group
Arm Description
Patients registered into personalized engagement platform (PEP) will receive personalized educational videos (PEV) according to disease, treatment protocol and side effects.
The control group will not be registered to the PEP nor receive any PEVs.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Secondary clinical outcomes 1 (mean number of referrals)
To monitor mean number of referrals to emergency room and admissions to the inpatient department.
Secondary clinical outcomes 2 (level of chemotoxicity)
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.
Secondary clinical outcomes 3 (Quality of Life)
To measure patient assessment of Quality of Life (QoL) using a validated questionnaire (QLQ-C30).
Secondary clinical outcomes 4 (treatment intensity and continuity)
To evaluate treatment intensity and continuity measured as number of chemotherapy cycles and cumulative chemotherapy dose.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04316078
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
April 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Gastric Cancer, Pancreas Cancer, Rectal Cancer, Cholangiocarcinoma, Small Bowel Cancer, Esophageal Cancer
Keywords
patient reported outcome, quality of life, personalized videos
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control study (2:1 allocation)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
personalized engagement platform
Arm Type
Experimental
Arm Description
Patients registered into personalized engagement platform (PEP) will receive personalized educational videos (PEV) according to disease, treatment protocol and side effects.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group will not be registered to the PEP nor receive any PEVs.
Intervention Type
Other
Intervention Name(s)
patient engagement platform
Intervention Description
Allows patients to receive the action plan as educational videos on demand.
Allows patients to report side effects and quality of life via questionnaires and receive immediate targeted education based on the predefined action plan.
Primary Outcome Measure Information:
Title
Feasibility of PEP (percent of patients using videos/complete questionnaires)
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Secondary clinical outcomes 1 (mean number of referrals)
Description
To monitor mean number of referrals to emergency room and admissions to the inpatient department.
Time Frame
3 years
Title
Secondary clinical outcomes 2 (level of chemotoxicity)
Description
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.
Time Frame
3 years
Title
Secondary clinical outcomes 3 (Quality of Life)
Description
To measure patient assessment of Quality of Life (QoL) using a validated questionnaire (QLQ-C30).
Time Frame
3 years
Title
Secondary clinical outcomes 4 (treatment intensity and continuity)
Description
To evaluate treatment intensity and continuity measured as number of chemotherapy cycles and cumulative chemotherapy dose.
Time Frame
3 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofer Margali, MD PhD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies
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