Clinical trial NCT06187610: Digital Delivery of Patient Education: A Case Study of Symptom Self-Management During Cancer Treatment
Official title: Digital Intervention for Gastrointestinal (GI) Cancer Patients: A Case Study on Enhancing Symptom Self-Management During Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Digital Education Interventions
Knowledge Types (Mechanistic Versus Procedural)
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Weizmann Institute of Science
First posted: 2024-01-02
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Symptom self-management knowledge
timeFrame: The test will be conducted in two time-points of the study, Time 0 (pre) and Time 2 (after two months)
Secondary outcomes:
measure: Self-efficacy in symptom management
timeFrame: The questionnaire will be administered three times: Time 0 (pre) and Time 2 (after two months)
measure: Confidence in decision making
timeFrame: The questionnaire will be administered in two time-points of the study, Time 0 (pre) and Time 2 (after two months)
measure: Patients engagement while learning
timeFrame: on Time 2, namely about two weeks to four weeks after recruitment
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Ichilov Hospital
Study officials:
References: