Digital Education InterventionsNCT06187610
Digital Delivery of Patient Education: A Case Study of Symptom Self-Management During Cancer Treatment
A study testing Digital education in people with Digital Education Interventions and Knowledge Types (Mechanistic Versus Procedural), run by Tel Aviv University at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Digital Education Interventions, Knowledge Types (Mechanistic Versus Procedural)
- What is being tested?
- Digital education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2022to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gastrointestinal (GI) cancer patients
- Chemotherapy session within a specific round of treatment, with eligible treatments including FOLFOX, FOLFIRINOX, and FLOT.
- Hebrew speakers.
Who cannot join
- Impaired or degraded cognitive capabilities that may hinder effective learning.
- Individuals who discontinue their treatments due to terminal advancement of their disease or death.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ichilov Hospital
Tel Aviv, 6423906
Tair Vizel, +97254-2444245, tairvi@gmail.com
About this study
Official title: 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.
- Being tested
- Digital education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital educationBehavioural
Patients assigned to the experimental group will learn about symptom self-management in a digital learning environment.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention group | Experimental | Not described Receives: Behavioral: Digital education |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom self-management knowledge
Measured by performance accuracy in a cancer-specific knowledge test
Measured: 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
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.
Measured: 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.
Measured: 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
Patients engagement with patient education material will be captured by psychophysiological parameters of eye-tracking and facial expressions
Measured: on Time 2, namely about two weeks to four weeks after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Oct 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Education InterventionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Principal investigator, Ilana Dubovi, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187610
- Sponsor's protocol ID
- CancerEducationTau
- Status last verified
- Dec 2023
- First submitted
- 17 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: upon request
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Intervention for Gastrointestinal (GI) Cancer Patients: A Case Study on Enhancing Symptom Self-Management During Treatment
- ClinicalTrials.gov ID
- NCT06187610
- Acronym / sponsor ID
- CancerEducationTau
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Weizmann Institute of Science
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational intervention group | Experimental | Behavioral: Digital education |
| Control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gastrointestinal (GI) cancer patients
- Chemotherapy session within a specific round of treatment, with eligible treatments including FOLFOX, FOLFIRINOX, and FLOT.
- Hebrew speakers.
Key exclusion criteria (2 listed)
- Impaired or degraded cognitive capabilities that may hinder effective learning.
- Individuals who discontinue their treatments due to terminal advancement of their disease or death.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital educationPatients assigned to the experimental group will learn about symptom self-management in a digital learning environment. | Behavioural | Educational intervention group |
Primary outcome
Symptom self-management knowledge
Time frame: The test will be conducted in two time-points of the study, Time 0 (pre) and Time 2 (after two months)
Measured by performance accuracy in a cancer-specific knowledge test
3 secondary outcomes
Self-efficacy in symptom management
Time frame: The questionnaire will be administered three times: Time 0 (pre) and Time 2 (after two months)
Confidence in decision making
Time frame: 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
Time frame: on Time 2, namely about two weeks to four weeks after recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No. upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital education in people with Digital Education Interventions and Knowledge Types (Mechanistic Versus Procedural), run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilana Dubovi (+97254-7922358, tairvi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom self-management knowledge (time frame: The test will be conducted in two time-points of the study, Time 0 (pre) and Time 2 (after two months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.