A randomized control trial to evaluate the feasibility of implementing a patient educational platform (PEP) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
126
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.
Sheba Medical Center
Ramat Gan, Israel
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.
Time frame: 3 years
Secondary clinical outcomes 1 (mean number of referrals)
To monitor mean number of referrals to emergency room and admissions to the inpatient department.
Time frame: 3 years
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.
Time frame: 3 years
Secondary clinical outcomes 3 (Quality of Life)
To measure patient assessment of Quality of Life (QoL) using a validated questionnaire (QLQ-C30).
Time frame: 3 years
Secondary clinical outcomes 4 (treatment intensity and continuity)
To evaluate treatment intensity and continuity measured as number of chemotherapy cycles and cumulative chemotherapy dose.
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.