Digital Delivery of Patient Education: A Case Study of Symptom Self-Management During Cancer Treatment

Digital Intervention for Gastrointestinal (GI) Cancer Patients: A Case Study on Enhancing Symptom Self-Management During Treatment

The increasing shift from face-to-face to online patient-clinician encounters in the healthcare system requires patients to be more involved in their medical care. This raises the urgent need to evaluate the extent to which proactive patients' self-care can be supported, particularly by informed telemedicine digital channels. Despite this imperative, research offering evidence-based instructional design of digital education remains surprisingly scarce. Embracing the framework of science education, which highlights the functional role of different knowledge types in educational processes, the current study seeks to evaluate an educational approach aimed at supporting cancer patients undergoing chemotherapy.

Cancer treatment serves as an exemplar health condition, demanding daily self-management from patients. The objectives of our research are as follows: (1) To delineate the types of knowledge required for effective symptom management, active participation in one's healthcare, and judicious decision-making regarding emergency room (ER) visits, with a focus on mechanistic knowledge pertaining to the rationale for treatment and procedural knowledge concerning the treatment regimen. (2) To appraise the impact of a digital learning environment in contrast to traditional methods on patients' acquisition of mechanistic and procedural knowledge. (3) To identify how patients engage with the digital patient education environment aiming to outline leaning patterns.

The investigators hypothesize that implementing digital education will enhance patients' understanding of both the 'why' (mechanistic) and 'how' (procedural) aspects of their treatment. Importantly, the investigators expect that mechanistic knowledge will be more impactful than procedural knowledge, leading to better symptom management and patient involvement, and ultimately reducing unnecessary visits to the ER.

Study Overview

• Status: Recruiting
• Conditions: Digital Education Interventions; Knowledge Types (Mechanistic Versus Procedural)
• Intervention / Treatment: Behavioral: Digital education

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilana Dubovi; Phone Number: +97254-7922358; Email: tairvi@gmail.com

Study Locations

• Israel
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Ichilov Hospital
    • Contact: Tair Vizel; Phone Number: +97254-2444245; Email: tairvi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Gastrointestinal (GI) cancer patients
• Chemotherapy session within a specific round of treatment, with eligible treatments including FOLFOX, FOLFIRINOX, and FLOT.
• Hebrew speakers.

Exclusion Criteria:

• Impaired or degraded cognitive capabilities that may hinder effective learning.
• Individuals who discontinue their treatments due to terminal advancement of their disease or death.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Educational intervention group	Behavioral: Digital education; Patients assigned to the experimental group will learn about symptom self-management in a digital learning environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom self-management knowledge	Measured by performance accuracy in a cancer-specific knowledge test	The test will be conducted in two time-points of the study, Time 0 (pre) and Time 2 (after two months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients engagement while learning	Patients engagement with patient education material will be captured by psychophysiological parameters of eye-tracking and facial expressions	on Time 2, namely about two weeks to four weeks after recruitment
Self-efficacy in symptom management	Measured by self-report Self-Efficacy for Managing Chronic Disease 6-Item Scale. The scale ranges from 1 (not confident) to 10 (very confident). A higher score is interpreted as a better self-efficacy.	The questionnaire will be administered three times: Time 0 (pre) and Time 2 (after two months)
Confidence in decision making	Measured by the self-report Decision Self-Efficacy Scale, which assesses patients' self-confidence in their ability to make decisions. It includes 11 items on a scale ranging from 0 (not at all confident) to 4 (very confident). A higher score is interpreted as higher confidence.	The questionnaire will be administered in two time-points of the study, Time 0 (pre) and Time 2 (after two months)

Collaborators and Investigators

• Sponsor: Tel Aviv University
• Collaborators: Weizmann Institute of Science

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: December 29, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 31, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CancerEducationTau

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No