A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies

Not Applicable

Completed

• Conditions: Rectal Cancer; Small Bowel Cancer; Esophageal Cancer; Colon Cancer; Pancreas Cancer; Cholangiocarcinoma; Gastric Cancer
• Interventions: Other: patient engagement platform

• Registration Number: NCT04316078
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study First Submitted: 2020-02-23
• Status Verified: 2020-03
• Study Start: 2020-03-15
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-20
• Primary Completion: 2021-07-15
• Study Completion: 2022-04-15
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Feasibility of PEP (percent of patients using videos/complete questionnaires)	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.

Secondary Outcome Measures

Name	Time	Method
Secondary clinical outcomes 1 (mean number of referrals)	3 years	To monitor mean number of referrals to emergency room and admissions to the inpatient department.
Secondary clinical outcomes 2 (level of chemotoxicity)	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.
Secondary clinical outcomes 3 (Quality of Life)	3 years	To measure patient assessment of Quality of Life (QoL) using a validated questionnaire (QLQ-C30).
Secondary clinical outcomes 4 (treatment intensity and continuity)	3 years	To evaluate treatment intensity and continuity measured as number of chemotherapy cycles and cumulative chemotherapy dose.

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel