Protocol: Feasibility of an Online Intervention to Increase Awareness of Gynaecological Cancer in UK Students

NCT07147283 | Completed

• 2 other identifiers: HOLCH_EVE_APPEALEVE/0032
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intervention

Keywords

Behaviour change; Theory of planned behaviour; Gynaecological Cancer; Volitional help sheet; Educational film

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrolment to 6 months

Secondary Outcomes (1)

• Theory of Planned Behaviour

  From enrolment to the end of 6 months

Study Arms (2)

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™.

Behavioral: Educational film and volitional help sheet

Interventions

Educational film and volitional help sheet BEHAVIORAL

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™.

Intervention: cancer awareness film and help sheet

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Leeds Beckett University: lead

Study Sites (1)

Leeds Beckett University

Leeds, West Yorkshire, LS1 3HE, United Kingdom

Location

Study Officials

• Trish Holch, PhD

  Leeds Beckett University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Applied Health Psychology

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 29, 2025
• Study Start: October 20, 2022
• Primary Completion: August 21, 2024
• Study Completion: August 24, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)