SarcomaNCT04619030
Augmented Reality (AR): The Future of "Patient Information Leaflets
A study testing Augmented Reality and Traditional leaflet in people with Sarcoma and Breast Cancer, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.
Trial summary
This project aims to assess a new type of Augmented Reality Patient Information leaflet, in order to demonstrate that it is a beneficial information resource to patients when facing the diagnosis of sarcoma, breast cancer or to explain difficult concepts such as cleft lip repair. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Sarcoma, Breast Cancer, Cleft Lip and Palate
- What is being tested?
- Augmented Reality and Traditional leaflet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 30 Nov 2020to 30 Mar 2022
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who have undergone reconstructive surgery
- patients who are awaiting reconstructive surgery
- patients with sarcoma
- patients with breast cancer
- patients with reconstructive flaps
- patients with or parents of patients with cleft lip and palate
- Patients with dyslexia will be included
Who cannot join
- Cannot speak or read English
- Blind/severely visually impaired
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Canniesburn Regional Plastic Surgery and Burns Unit
Glasgow, Scotland, G4 0SF
Steven Lo, FRCS Plast, 0141 2114000 ext. 4475, steven.lo@nhs.net
David McGill, FRCS Plast, 0141 211 4000
- Recruiting
Glasgow Royal Infirmary
Glasgow, Scotland, G4 0SF
Steven Lo, 01412114000, Steven.lo@ggc.scot.nhs.uk
- Recruiting
Royal Hospital for Children
Glasgow, Scotland, G51 4TF
Steven Lo, 01412114000, Steven.lo@ggc.scot.nhs.uk
About this study
This project aims to assess a new type of Augmented Reality Patient Information leaflet, in order to demonstrate that it is a beneficial information resource to patients when facing the diagnosis of sarcoma, breast cancer or to explain difficult concepts such as cleft lip repair. There are no published studies on the use of AR in patient leaflets.
Read the detailed description
At present, the traditional approach to patient education regarding diseases such as a new cancer diagnosis, is the patient information leaflet. Patient information leaflets often fail to convey the required medical information due to poor levels of literacy in the population, with 20% patients in the UK having the lowest level of adult literacy (equivalent to an individual who is unable to determine how much medicine to give a child from information printed on the package). "Health literacy" - the ability to obtain, understand, act on and communicate health information - is even lower, with estimates that 40% of patients have inadequate levels of health literacy. Additionally, there is a large knowledge gap between what doctors perceive patients understand about an illness, medication, or operation, and what patients actually comprehend and retain during consultation.
The plethora of problems of inadequate information, poor health literacy and patient-doctor knowledge disconnect, may be addressed with an approach to patient information leaflets using a platform that is entirely simulative and visual, thereby overcoming the problem of health literacy. The study builds upon pilot work by this research team on patient leaflets using AR to aid in patient education, visualisation and retention of information (Lo et al 2019).
- Conditions
- Sarcoma, Breast Cancer, Cleft Lip and Palate, Surgical Flap
- Being tested
- Augmented Reality, Traditional leaflet
- Keywords
- patient information leaflet, augmented reality
- Medical subject headings
- Sarcoma, Breast Neoplasms, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented RealityOther
The patient leaflet has an Augmented Reality model that appears out of the leaflet when viewed with a smartphone
Traditional leafletOther
Traditional leaflet with no Augmented Reality capability
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality Leaflet | Experimental | Patient Leaflet with Augmented reality component Receives: Other: Augmented Reality |
| Traditional Leaflet | Active comparator | Traditional leaflet without Augmented Reality component Receives: Other: Traditional leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Effort Rating Scale
Validated scale for cognitive load/ ease of understanding leaflet. Single item scale with rating 1 = very, very low mental effort to 9 = very, very high mental effort. Lower score is better
Measured: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Secondary outcomes (3)
Overall Patient Satisfaction
Visual analogue scale, overall satisfaction with patient leaflet. Visual analogue scale will be converted to numerical scale 0-100, with higher being better or more satisfied
Measured: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Instructional Motivation Materials Survey
Assessment of patient learning motivation after reading leaflet. 36 items, each item rated by Likert scale 1-5. Higher score is better.
Measured: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Usefulness Scale for Patient Information (USE scale)
9 item scale with Likert rating 0-10 for each item. Total score out of 90, with 3 sub scales measuring cognitive, emotional and behavioural dimensions. Higher score is better.
Measured: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start30 Nov 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- The Glasgow School of Art
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619030
- Sponsor's protocol ID
- GN19HS442
- Status last verified
- May 2021
- First submitted
- 2 Nov 2020
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available on reasonable written request following publication.
Publications
Lo SJ, Chapman P, Young D, Drake D, Devlin M, Russell C. The Cleft Lip Education with Augmented Reality (CLEAR) VR Phase 2 Trial: A Pilot Randomized Crossover Trial of a Novel Patient Information Leaflet. Cleft Palate Craniofac J. 2023 Feb;60(2):179-188. doi: 10.1177/10556656211059709. Epub 2022 Jan 4.
PubMed 34982018
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality (AR): The Future of "Patient Information Leaflets
- ClinicalTrials.gov ID
- NCT04619030
- Acronym / sponsor ID
- GN19HS442
- Conditions
- Sarcoma, Breast Cancer, Cleft Lip and Palate, Surgical Flap
- Keywords
- patient information leaflet, augmented reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- The Glasgow School of Art
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 6 Nov 2020 (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.
This project aims to assess a new type of Augmented Reality Patient Information leaflet, in order to demonstrate that it is a beneficial information resource to patients when facing the diagnosis of sarcoma, breast cancer or to explain difficult concepts such as cleft lip repair. There are no published studies on the use of AR in patient leaflets.
Detailed description
At present, the traditional approach to patient education regarding diseases such as a new cancer diagnosis, is the patient information leaflet. Patient information leaflets often fail to convey the required medical information due to poor levels of literacy in the population, with 20% patients in the UK having the lowest level of adult literacy (equivalent to an individual who is unable to determine how much medicine to give a child from information printed on the package). "Health literacy" - the ability to obtain, understand, act on and communicate health information - is even lower, with estimates that 40% of patients have inadequate levels of health literacy. Additionally, there is a large knowledge gap between what doctors perceive patients understand about an illness, medication, or operation, and what patients actually comprehend and retain during consultation.
The plethora of problems of inadequate information, poor health literacy and patient-doctor knowledge disconnect, may be addressed with an approach to patient information leaflets using a platform that is entirely simulative and visual, thereby overcoming the problem of health literacy. The study builds upon pilot work by this research team on patient leaflets using AR to aid in patient education, visualisation and retention of information (Lo et al 2019).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised crossover
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality Leaflet | Experimental | Other: Augmented RealityPatient Leaflet with Augmented reality component |
| Traditional Leaflet | Active comparator | Other: Traditional leafletTraditional leaflet without Augmented Reality component |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- patients who have undergone reconstructive surgery
- patients who are awaiting reconstructive surgery
- patients with sarcoma
- patients with breast cancer
- patients with reconstructive flaps
Key exclusion criteria (2 listed)
- Cannot speak or read English
- Blind/severely visually impaired
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 |
|---|---|---|
| Augmented RealityThe patient leaflet has an Augmented Reality model that appears out of the leaflet when viewed with a smartphone | Other | Augmented Reality Leaflet |
| Traditional leafletTraditional leaflet with no Augmented Reality capability | Other | Traditional Leaflet |
Primary outcome
Mental Effort Rating Scale
Time frame: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Validated scale for cognitive load/ ease of understanding leaflet. Single item scale with rating 1 = very, very low mental effort to 9 = very, very high mental effort. Lower score is better
3 secondary outcomes
Overall Patient Satisfaction
Time frame: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Instructional Motivation Materials Survey
Time frame: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Usefulness Scale for Patient Information (USE scale)
Time frame: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Derived from this study: PubMed 34982018Lo SJ, Chapman P, Young D, Drake D, Devlin M, Russell C. The Cleft Lip Education with Augmented Reality (CLEAR) VR Phase 2 Trial: A Pilot Randomized Crossover Trial of a Novel Patient Information Leaflet. Cleft Palate Craniofac J. 2023 Feb;60(2):179-188. doi: 10.1177/10556656211059709. Epub 2022 Jan 4.
- Individual participant dataSharing planned: Yes. Available on reasonable written request following publication.
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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.
Canniesburn Regional Plastic Surgery and Burns Unit
Glasgow, United Kingdom
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality and Traditional leaflet in people with Sarcoma and Breast Cancer, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.
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 7 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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Effort Rating Scale (time frame: Single point at day 1 (Patient assesses leaflet once after reading leaflet)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04619030, which also lists 1 linked publication.
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 10 Jun 2021.