Testing an education programme to help people impacted by cancer assess health information and spot misinformation
| ISRCTN | ISRCTN17391470 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17391470 |
- Submission date
- 30/04/2025
- Registration date
- 08/05/2025
- Last edited
- 08/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The Informed Health Choices-Cancer (IHC-C) programme is an online educational programme designed to help those impacted by cancer develop the skills and knowledge necessary to think critically about the reliability of health claims and make well-informed choices. It was developed by this research team working together with current cancer patients, cancer survivors, caregivers, loved ones, oncologists, cancer nurses, cancer researchers, and educators. The development of the program was supported by the Irish Cancer Society. This study aims to find out if the programme is feasible and acceptable for use by people impacted by cancer.
Who can participate?
Adults aged 18 years and older who are impacted by cancer can take part. This includes current patients, survivors, informal caregivers, and loved ones of people diagnosed with cancer. Participants must have internet access.
What does the study involve?
This study is conducted entirely online, providing participants with the flexibility to access resources at times and locations that are most convenient for them.
To begin, participants are required to carefully read the provided information sheet. If they choose to participate, they must sign a consent form. Participants will then be randomly assigned to one of two groups. The first group will commence the programme immediately, while the second group will start four weeks later. This random assignment, akin to flipping a coin, is used to help researchers better understand the programme's effectiveness.
During the study, participants will access and complete the online Informed Health Choices-Cancer programme, following the provided instructions at their own pace. The programme is designed to run for four weeks.
Participants are also required to complete a survey at the beginning of the study and a follow-up survey at the end of the four weeks. All activities, including the surveys, can be completed from home or any location with internet access.
What are the possible benefits of taking part?
Participants will get free access to the Informed Health Choices-Cancer programme. This can help improve how people impacted by cancer think about whether health information is reliable and how they make decisions about their health. They will also have the chance to share their experiences and help influence cancer research.
What are the risks or disadvantages of taking part?
There is a small chance that some information might be upsetting; however, this risk is considered to be very small. If this happens, participants can:
• Contact the research team at ihccancer@universityofgalway.ie,
• Reach out to the Irish Cancer Society for free advice or assistance in finding support in your community at supportline@irishcancer.ie or by calling 1800 200 700.
• Stop taking part at any time, and there will be no problems if you choose to do so.
Where is the study run from?
The School of Nursing & Midwifery, University of Galway, Ireland.
When is the study starting and how long is it expected to run for?
December 2024 to November 2025. Study recruitment is expected to start in May 2025 and run for approximately four months, including recruitment, programme delivery, and follow-up.
Who is funding the study?
The College of Medicine, Nursing and Health Sciences at the University of Galway.
Who is the main contact?
Mengqi Li, School of Nursing & Midwifery, University of Galway, Ireland, Email: m.li10@nuigalway.ie
Contact information
Public, Scientific
Áras Moyola, School of Nursing & Midwifery, University of Galway
Galway
H91 TK33
Ireland
 ORCID ID |
0000-0001-5751-7164 |
|---|---|
| Phone | +353 0894950907 |
| m.li10@nuigalway.ie |
Principal Investigator
Áras Moyola, School of Nursing & Midwifery, University of Galway
Galway
H91 TK33
Ireland
| ORCID ID |
0000-0002-9393-7075 |
|---|---|
| Phone | +353 91 524411 |
| declan.devane@universityofgalway.ie |
Principal Investigator
Trinity College Dublin, The University of Dublin.
College Green, Dublin 2
Dublin
D02 PN40
Ireland
| ORCID ID |
0000-0002-2428-0188 |
|---|---|
| Phone | +353 1 896 1000 |
| tiernem5@tcd.ie |
Study information
| Study design | Pilot randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Charity/Voluntary sector, Community, Home, Internet/virtual |
| Study type | Prevention, Quality of life |
| Participant information sheet | 47258_PIS.pdf |
| Scientific title | Evaluating the feasibility and acceptability of the Informed Health Choices-Cancer programme: a pilot randomised trial |
| Study acronym | IHC-C |
| Study objectives | The Informed Health Choices-Cancer (IHC-C) programme is a feasible and acceptable online education intervention to strengthen health literacy and critical thinking about health information and misinformation among people impacted by cancer. |
| Ethics approval(s) |
Approved 21/01/2025, University of Galway Research Ethics Committee (University Road, Galway, H91 TK33, Ireland; +353 91 524411; ethics@universityofgalway.ie), ref: 2024.12.018 |
| Health condition(s) or problem(s) studied | Prevention of harm from health misinformation in people impacted by cancer |
| Intervention | • Participants are randomised 1:1 to either an intervention group or a waitlist control group. • The intervention group receives access to the Informed Health Choices–Cancer (IHC-Cancer) programme: an online education programme consisting of nine self-paced units delivered over four weeks. The programme is co-created with patients and public contributors, and is designed to strengthen health literacy, critical thinking, and decision-making skills about health information and misinformation. • The intervention includes text, short videos, real-life examples, interactive questions, and reflection activities. It is delivered entirely online through a secure learning platform (Moodle), and no face-to-face contact is required. Participants use their own devices (computer, tablet, or phone) and are encouraged to complete two to three units per week, though they may work at their own pace. • Automated email reminders are used to encourage engagement. The research team manages the programme, and no additional staff training is needed to deliver the content. • The waitlist control group receives no intervention during the first four weeks but will gain full access to the same online programme after completing the follow-up assessment. • Total follow-up is four weeks from enrolment for both groups. • Randomisation is carried out using a computer-generated sequence with permuted blocks of varying sizes. To minimise allocation bias, randomisation is stratified to ensure balanced distribution across different participant types (e.g. patients, caregivers, loved ones). Block sizes remain concealed until the completion of the trial. Allocation is implemented automatically via a secure online survey platform (QuestionPro) following consent and baseline data submission. • The intervention is not tailored or personalised, and no modifications are currently planned. Adherence will be assessed by the research team using learning platform data, including login frequency, time spent on each unit, and completion rates. To support engagement and intervention fidelity, automated email reminders will be sent, and participants will receive a welcome message and technical guidance. No direct supervision or facilitator support is provided during delivery. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Feasibility: Recruitment efficiency, retention, adherence, technical feasibility, and data collection efficacy will be measured using learning platform data, researcher logs and self-reported questionnaire items developed for this study at four weeks post-randomisation. 2. Acceptability: Participation rates, participation burden, participants’ perspectives, and general acceptability will be assessed using self-reported questionnaire items developed for this study at four weeks post-randomisation. |
| Secondary outcome measures | 1. Critical thinking and decision-making skills will be measured using a scenario-based assessment questionnaire developed for this study at four weeks post-randomisation. 2. eHealth literacy will be measured using the eHealth Literacy Scale (eHEALS) at four weeks post-randomisation. 3. Cognition and behaviour change will be measured using self-reported questionnaire items developed for this study at 4 weeks post-randomisation. |
| Overall study start date | 10/12/2024 |
| Completion date | 01/11/2025 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient, Carer, Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Age ≥ 18 years 2. Current patients and survivors – diagnosed with any type of cancer 3. Current patients – person currently undergoing treatment for any type of cancer 4. Survivors – those who have completed treatment and with or without current care/follow-up 5. Informal caregivers – those who provide the majority of unpaid, informal care, and self-identify as informal caregivers for a person diagnosed with cancer 6. Loved ones – family member, friend, or someone who cares about a person diagnosed with cancer, and who self-identifies as a loved one of a person diagnosed with cancer 7. Be able to commit to the study for at least four weeks 8. Can give informed consent 9. Can access the internet |
| Key exclusion criteria | 1. Currently involved in another similar study 2. Irregular and frequently changing caregivers (for informal caregivers) |
| Date of first enrolment | 12/05/2025 |
| Date of final enrolment | 01/10/2025 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Galway
H91 TK33
Ireland
Sponsor information
University/education
School of Nursing & Midwifery, University Road
Galway
H91 TK33
Ireland
| Phone | +353 91 524411 |
|---|---|
| nursing.midwifery@universityofgalway.ie | |
| Website | https://www.universityofgalway.ie/medicine-nursing-and-health-sciences/nursing-midwifery/ |
"ROR" |
https://ror.org/03bea9k73 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- College of Medicine, Nursing and Health Sciences, National University of Ireland, Galway, College of Medicine Nursing & Health Sciences, NUI Galway - College of Medicine, Nursing and Health Sciences, College of Medicine, Nursing & Health Sciences - NUI Galway
- Location
- Ireland
Results and Publications
| Intention to publish date | 01/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| Publication and dissemination plan | Both the design protocol and the results of this pilot randomised trial will be published in peer-reviewed journals and shared through presentations at conferences. A lay summary of the findings will also be provided to participants. |
| IPD sharing plan | Individual participant data will not be made available due to data protection requirements. Aggregated, analysed data will be included in future journal publications and conference presentations. Only summarised results will be reported. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/05/2025 | No | Yes |
Additional files
Editorial Notes
30/04/2025: Study's existence confirmed by the University of Galway Research Ethics Committee.
