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

NCT06187610 | Unknown

• 1 other identifier: CancerEducationTau
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Digital Education Interventions; Knowledge Types (Mechanistic Versus Procedural)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Self-efficacy in symptom management

  The questionnaire will be administered three times: Time 0 (pre) and Time 2 (after two months)

• Confidence in decision making

  The questionnaire will be administered in two time-points of the study, Time 0 (pre) and Time 2 (after two months)

• Patients engagement while learning

  on Time 2, namely about two weeks to four weeks after recruitment

Study Arms (2)

Educational intervention group

EXPERIMENTAL

Behavioral: Digital education

Control group

NO INTERVENTION

Interventions

Digital education BEHAVIORAL

Patients assigned to the experimental group will learn about symptom self-management in a digital learning environment.

Educational intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel Aviv University: lead
• Weizmann Institute of Science: collaborator

Study Sites (1)

Ichilov Hospital

Tel Aviv, 6423906, Israel

RECRUITING

Central Study Contacts

Ilana Dubovi

CONTACT

+97254-7922358; tairvi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 2, 2024
• Study Start: October 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)