InterventionGoCheckNCT07147283
Protocol: Feasibility of an Online Intervention to Increase Awareness of Gynaecological Cancer in UK Students
A study testing Educational film and volitional help sheet in people with Intervention, run by Leeds Beckett University at 1 site in United Kingdom.
Trial summary
In the UK more than 2500 young people are diagnosed with cancer each year, including gynaecological cancers) and almost a third will be diagnosed within accident and emergency departments. Early diagnosis is essential to improve cancer outcomes. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intervention
- What is being tested?
- Educational film and volitional help sheet
- 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 siteUnited Kingdom
- Study dates
- 20 Oct 2022to 24 Aug 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 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female students (or those at risk of gynaecological cancer e.g., have ovaries, a uterus, cervix).
- over 18 years of age
- attending UK universities
- resident in the UK
- able to understand written English.
Who cannot join
- non- female students and those who are not at risk of gynaecological cancer e.g. (don't have ovaries, a uterus, cervix)
- under 18 years of age
- non UK residents
- not able to understand written English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Beckett University
Leeds, West Yorkshire, LS1 3HE
About this study
Official title: Study Protocol, Increasing Awareness and Early Detection in Students at Risk of Gynaecological Cancer: Feasibility of an Online Educational and Behaviour Change Intervention
In the UK more than 2500 young people are diagnosed with cancer each year, including gynaecological cancers) and almost a third will be diagnosed within accident and emergency departments. Early diagnosis is essential to improve cancer outcomes. However, despite awareness of warning signs, most young people would delay or avoid seeking help altogether. The key to lifelong monitoring and early detection of cancer is early exposure to cancer information at a formative age. University is seen as a key life transition phase which will enable students to establish positive health behaviours.
We have developed an online intervention to change behaviour for university students to support the early detection and intention to seek help for symptoms of gynaecological cancer. The intervention consists of a gynaecological cancer awareness educational film and a help sheet to plan future help seeking. The aim of this study is to find out if the intervention is acceptable for participants and practicable to run.
Read more
Methods We aim to recruit 86 participants who are women (or those at risk of gynaecological cancer e.g., have ovaries, a uterus, cervix) over 18 at UK universities who can understand English. The educational film provides information about the signs and symptoms of the five different forms of gynaecological cancer and will be delivered online to participants. The help sheet encourages participants to self-monitor for gynaecological symptoms and then identify cues to help-seeking/action. Cancer awareness and willingness to seek help for symptoms will be assessed by questionnaires four times at the beginning, and at 4 weeks, 3 months and 6 months). Interviews will be carried out with participants to understand how acceptable the intervention is.
Results Acceptability will be measured by looking at how many people have been recruited and how many have dropped out of the study, how long they have taken to watch the film and to complete the help sheet. Interviews will be analysed by theme.
Conclusion We hope that the findings from this study will provide evidence of how the intervention can increase cancer awareness and likelihood of help seeking for cancer symptoms. The long-term goal is to use these findings to use this intervention in other universities in the UK.
Read the detailed description
Background In the UK more than 2500 Teenage and Young Adult (TYA) are diagnosed with cancer each year, the majority being melanomas or carcinomas (including gynaecological cancers). Alarmingly, almost a third (29%) of TYA cancers are diagnosed within accident and emergency departments. Early diagnosis is key to improved cancer outcomes. However, although a sample of university students, could identify the common cancer warning signs, (e.g. lumps, bleeding) they could not identify those less common including; constipation, frequency in urination and bloating. Further, despite awareness of warning signs, most young people would delay or avoid seeking help altogether. The key to lifelong monitoring and early detection of cancer is early exposure to cancer information and body awareness at a formative age. University is seen as a key life transition phase which will enable students to establish positive health behaviours.
We have developed an online behaviour change intervention for university students to support the early detection and intention to seek help for symptoms of gynaecological cancer. The intervention consists of a bespoke online gynaecological cancer awareness educational film and a volitional help sheet to plan future gynaecological help seeking. Aim: To establish the feasibility and acceptability of the intervention and to understand the barriers and enablers to uptake and how to improve the intervention to develop a definitive study for launch in UK Universities.
Methods A longitudinal 1:1 randomised mixed methods feasibility study design will be employed. Eligible participants are women (or those at risk of gynaecological cancer e.g., have ovaries, a uterus, cervix) over 18 at UK universities who can understand English. We aim to recruit N=86 participants online from UK Universities. The educational film provides information about the signs and symptoms of the five different forms of gynaecological cancer and will be delivered online to participants via Qualtrics™. The volitional help sheet encourages participants to self-monitor for gynaecological symptoms and then use a standard implementation intention exercise to identify cues to help-seeking/action. Cancer awareness will be assessed by the Young Person's Cancer Awareness Measure (YPCAM) at baseline, 4 weeks, 3 months and 6 months, along with assessment of the Theory of Planned Behaviour (TPB) domains. Semi-structured interviews with a subsection of the intervention group will explore the barriers and enablers to uptake.
Results Feasibility will be measured by assessing the proportion of recruitment and attrition rates per time point, study completion and adherence to the educational film and volitional help sheet. Mean score changes (intervention vs control) will be examined over the four timepoints adjusting for a single covariate (baseline scores). Interview data will be analysed using the six stages of reflexive thematic analysis. Progression criteria to a main trial would be the successful recruitment of 80% of the target sample.
Conclusion We hope the findings from this study will provide empirical evidence on the potential of the intervention to enhance cancer awareness and help-seeking behaviours for symptoms of gynaecological cancer among TYA. The long-term goal is to harness the insight gained form this study to provide evidence-based data that support the broader integration of open cancer awareness initiatives within university settings.
- Conditions
- Intervention
- Being tested
- Educational film and volitional help sheet
- Keywords
- Behaviour change, Theory of planned behaviour, Gynaecological Cancer, Volitional help sheet, Educational film
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational film and volitional help sheetBehavioural
The intervention consists of a bespoke online gynaecological cancer awareness educational film and a volitional help sheet to plan future gynaecological help seeking and monitoring based on implementation intention principles [24]. The intervention will be delivered online using Qualtrics™.
| Study group | Role | What they receive |
|---|---|---|
| No cancer awareness film and help sheet | No intervention | Participants assigned to the control condition will have no exposure to cancer education over and above what is available generally and be assessed on their previously accrued cancer information. They will take part in the study and complete the questionnaires at baseline, 4 weeks, 3 months and 6 months. |
| Intervention: cancer awareness film and help sheet | Experimental | The intervention consists of a bespoke online gynaecological cancer awareness educational film and a volitional help sheet to plan future gynaecological help seeking and monitoring based on implementation intention principles. The intervention will be delivered online using Qualtrics™. Receives: Behavioral: Educational film and volitional help sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Young Person Cancer Awareness Measure
Young Person's Cancer Awareness Measure (YPCAM) (supplementary information 1) at Baseline, 4-weeks, 3, 6 months. This 10-item measure is based on the adult Cancer Awareness Measure (CAM). Validated in adults (aged 18), assessing knowledge of cancer types, incidence rates, warning signs/symptoms and risk factors, and explores help-seeking intervals, past experience, and potential help-seeking barriers. A further iteration of this instrument (the YPCAM for TYA ≥16) was developed by the Teenage Cancer Trust and Dr Martin McCabe University of Manchester and includes the addition of advocacy and decision-making questions and has been utilised in UK studies However, the YPCAM has not yet been formally validated in TYA and therefore this limits the reliability of the findings. Scores range from one to five with five showing greater cancer awareness and willingness to help seek.
Measured: From enrolment to 6 months
Secondary outcomes (1)
Theory of Planned Behaviour
Theory of Planned Behaviour (TPB) (supplementary information 2) questionnaire at Baseline, 4-weeks, 3, 6 months. The TPB is the most widely used effective model in predicting intention, stating that intention is the precursor of behaviour. We have developed a questionnaire incorporating these factors based around a cervical cancer questionnaire used with young women in Ireland. This will explore participants attitudes, intentions, subjective norms, anticipated regret and perceived behavioural control in relation to cancer awareness and help-seeking. Scores on the TPB range from questionnaire range from 1-7 and lower scores within each of the domains translate to increased positive attitudes from themselves and friends and family; greater perceived behavioural control and behavioural intentions and greater anticipated regret.
Measured: From enrolment to the end of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start20 Oct 2022
- Primary completion21 Aug 2024
- Study completion24 Aug 2024
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 InterventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Design This is a randomised mixed methods feasibility study with repeated measures and adheres to the Medical Research Council (MRC) guidance on the development, implementation, and evaluation of complex health care interventions. Young women (or transexual or non- binary individuals with female anatomy) at UK universities will be randomised with 1:1 allocation to either an intervention (an online gynaecological cancer awareness film and volitional help sheet implementation behaviour change intervention) or the control condition via the randomisation facility in Qualtrics™. Cancer awareness and plans for self-monitoring will be assessed at baseline, 4 weeks, 3 months and 6 months, along with assessment of the theory of planned behaviour domains (supplementary information 2). Feasibility of the intervention will be assessed by recruitment and retention rates and qualitative interviews.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leeds Beckett University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trish Holch, Leeds Beckett University
- Investigators
- Trish Holch, PhD, Principal investigator, Leeds Beckett University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147283
- Sponsor's protocol ID
- HOLCH_EVE_APPEAL
- Other IDs
- EVE/0032
- Acronym
- GoCheck
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared due to ethical reasons.
Publications
Holch P, Bagnall AM, Hughes S, McSorley LK. Study protocol, increasing awareness and early detection in students at risk of gynaecological cancer: feasibility of an online educational and behaviour change intervention. Pilot Feasibility Stud. 2026 Apr 21;12(1):83. doi: 10.1186/s40814-026-01801-1.
PubMed 42010640
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol, Increasing Awareness and Early Detection in Students at Risk of Gynaecological Cancer: Feasibility of an Online Educational and Behaviour Change Intervention
- ClinicalTrials.gov ID
- NCT07147283
- Acronym / sponsor ID
- GoCheck / HOLCH_EVE_APPEAL
- Conditions
- Intervention
- Keywords
- Behaviour change, Theory of planned behaviour, Gynaecological Cancer, Volitional help sheet, Educational film
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Leeds Beckett UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 24 Aug 2024 (actual)
- First posted
- 29 Aug 2025 (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.
In the UK more than 2500 young people are diagnosed with cancer each year, including gynaecological cancers) and almost a third will be diagnosed within accident and emergency departments. Early diagnosis is essential to improve cancer outcomes. However, despite awareness of warning signs, most young people would delay or avoid seeking help altogether. The key to lifelong monitoring and early detection of cancer is early exposure to cancer information at a formative age. University is seen as a key life transition phase which will enable students to establish positive health behaviours.
We have developed an online intervention to change behaviour for university students to support the early detection and intention to seek help for symptoms of gynaecological cancer. The intervention consists of a gynaecological cancer awareness educational film and a help sheet to plan future help seeking. The aim of this study is to find out if the intervention is acceptable for participants and practicable to run.
Methods We aim to recruit 86 participants who are women (or those at risk of gynaecological cancer e.g., have ovaries, a uterus, cervix) over 18 at UK universities who can understand English. The educational film provides information about the signs and symptoms of the five different forms of gynaecological cancer and will be delivered online to participants. The help sheet encourages participants to self-monitor for gynaecological symptoms and then identify cues to help-seeking/action. Cancer awareness and willingness to seek help for symptoms will be assessed by questionnaires four times at the beginning, and at 4 weeks, 3 months and 6 months). Interviews will be carried out with participants to understand how acceptable the intervention is.
Results Acceptability will be measured by looking at how many people have been recruited and how many have dropped out of the study, how long they have taken to watch the film and to complete the help sheet. Interviews will be analysed by theme.
Conclusion We hope that the findings from this study will provide evidence of how the intervention can increase cancer awareness and likelihood of help seeking for cancer symptoms. The long-term goal is to use these findings to use this intervention in other universities in the UK.
Detailed description
Background In the UK more than 2500 Teenage and Young Adult (TYA) are diagnosed with cancer each year, the majority being melanomas or carcinomas (including gynaecological cancers). Alarmingly, almost a third (29%) of TYA cancers are diagnosed within accident and emergency departments. Early diagnosis is key to improved cancer outcomes. However, although a sample of university students, could identify the common cancer warning signs, (e.g. lumps, bleeding) they could not identify those less common including; constipation, frequency in urination and bloating. Further, despite awareness of warning signs, most young people would delay or avoid seeking help altogether. The key to lifelong monitoring and early detection of cancer is early exposure to cancer information and body awareness at a formative age. University is seen as a key life transition phase which will enable students to establish positive health behaviours.
We have developed an online behaviour change intervention for university students to support the early detection and intention to seek help for symptoms of gynaecological cancer. The intervention consists of a bespoke online gynaecological cancer awareness educational film and a volitional help sheet to plan future gynaecological help seeking. Aim: To establish the feasibility and acceptability of the intervention and to understand the barriers and enablers to uptake and how to improve the intervention to develop a definitive study for launch in UK Universities.
Methods A longitudinal 1:1 randomised mixed methods feasibility study design will be employed. Eligible participants are women (or those at risk of gynaecological cancer e.g., have ovaries, a uterus, cervix) over 18 at UK universities who can understand English. We aim to recruit N=86 participants online from UK Universities. The educational film provides information about the signs and symptoms of the five different forms of gynaecological cancer and will be delivered online to participants via Qualtrics™. The volitional help sheet encourages participants to self-monitor for gynaecological symptoms and then use a standard implementation intention exercise to identify cues to help-seeking/action. Cancer awareness will be assessed by the Young Person's Cancer Awareness Measure (YPCAM) at baseline, 4 weeks, 3 months and 6 months, along with assessment of the Theory of Planned Behaviour (TPB) domains. Semi-structured interviews with a subsection of the intervention group will explore the barriers and enablers to uptake.
Results Feasibility will be measured by assessing the proportion of recruitment and attrition rates per time point, study completion and adherence to the educational film and volitional help sheet. Mean score changes (intervention vs control) will be examined over the four timepoints adjusting for a single covariate (baseline scores). Interview data will be analysed using the six stages of reflexive thematic analysis. Progression criteria to a main trial would be the successful recruitment of 80% of the target sample.
Conclusion We hope the findings from this study will provide empirical evidence on the potential of the intervention to enhance cancer awareness and help-seeking behaviours for symptoms of gynaecological cancer among TYA. The long-term goal is to harness the insight gained form this study to provide evidence-based data that support the broader integration of open cancer awareness initiatives within university settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Design This is a randomised mixed methods feasibility study with repeated measures and adheres to the Medical Research Council (MRC) guidance on the development, implementation, and evaluation of complex health care interventions. Young women (or transexual or non- binary individuals with female anatomy) at UK universities will be randomised with 1:1 allocation to either an intervention (an online gynaecological cancer awareness film and volitional help sheet implementation behaviour change intervention) or the control condition via the randomisation facility in Qualtrics™. Cancer awareness and plans for self-monitoring will be assessed at baseline, 4 weeks, 3 months and 6 months, along with assessment of the theory of planned behaviour domains (supplementary information 2). Feasibility of the intervention will be assessed by recruitment and retention rates and qualitative interviews.
| Arm | Type | Receives |
|---|---|---|
| No cancer awareness film and help sheet | No intervention | –Participants assigned to the control condition will have no exposure to cancer education over and above what is available generally and be assessed on their previously accrued cancer information. They will take part in the study and complete the questionnaires at baseline, 4 weeks, 3 months and 6 months. |
| Intervention: cancer awareness film and help sheet | Experimental | Behavioral: Educational film and volitional help sheetThe intervention consists of a bespoke online gynaecological cancer awareness educational film and a volitional help sheet to plan future gynaecological help seeking and monitoring based on implementation intention principles. The intervention will be delivered online using Qualtrics™. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female students (or those at risk of gynaecological cancer e.g., have ovaries, a uterus, cervix).
- over 18 years of age
- attending UK universities
- resident in the UK
- able to understand written English.
Key exclusion criteria (4 listed)
- non- female students and those who are not at risk of gynaecological cancer e.g. (don't have ovaries, a uterus, cervix)
- under 18 years of age
- non UK residents
- not able to understand written English
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 |
|---|---|---|
| Educational film and volitional help sheetThe intervention consists of a bespoke online gynaecological cancer awareness educational film and a volitional help sheet to plan future gynaecological help seeking and monitoring based on implementation intention principles [24]. The intervention will be delivered online using Qualtrics™. | Behavioural | Intervention: cancer awareness film and help sheet |
Primary outcome
Young Person Cancer Awareness Measure
Time frame: From enrolment to 6 months
Young Person's Cancer Awareness Measure (YPCAM) (supplementary information 1) at Baseline, 4-weeks, 3, 6 months. This 10-item measure is based on the adult Cancer Awareness Measure (CAM). Validated in adults (aged 18), assessing knowledge of cancer types, incidence rates, warning signs/symptoms and risk factors, and explores help-seeking intervals, past experience, and potential help-seeking barriers. A further iteration of this instrument (the YPCAM for TYA ≥16) was developed by the Teenage Cancer Trust and Dr Martin McCabe University of Manchester and includes the addition of advocacy and decision-making questions and has been utilised in UK studies However, the YPCAM has not yet been formally validated in TYA and therefore this limits the reliability of the findings. Scores range from one to five with five showing greater cancer awareness and willingness to help seek.
1 secondary outcome
Theory of Planned Behaviour
Time frame: From enrolment to the end of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Derived from this study: PubMed 42010640Holch P, Bagnall AM, Hughes S, McSorley LK. Study protocol, increasing awareness and early detection in students at risk of gynaecological cancer: feasibility of an online educational and behaviour change intervention. Pilot Feasibility Stud. 2026 Apr 21;12(1):83. doi: 10.1186/s40814-026-01801-1.
- Individual participant dataSharing planned: No. Individual data will not be shared due to ethical reasons.
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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.
Trish Holch, PhD principal investigator
Leeds Beckett University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational film and volitional help sheet in people with Intervention, run by Leeds Beckett University at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 29 Aug 2025. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Young Person Cancer Awareness Measure (time frame: From enrolment to 6 months). 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 NCT07147283, 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 29 Aug 2025.