A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies

Gastric Cancer Clinical Trial

Official title:

A Novel Patient Engagement Platform Used to Improve Understanding, Treatment Compliance and Quality of Care Among Patients With Gastrointestinal Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316078
• Other study ID #: SHEBA-19-6013-YL-CTIL
• Status: Completed
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: April 15, 2022

Study information

• Verified date: March 2020
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: April 15, 2022
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Colon Cancer
• Esophageal Cancer
• Gastric Cancer
• Pancreas Cancer
• Pancreatic Neoplasms
• Rectal Cancer
• Small Bowel Cancer

Intervention

Other:
• patient engagement platform
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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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