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

NCT ID: NCT07147283

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2024-08-24

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

No cancer awareness film and help sheet

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention: cancer awareness film and help sheet

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™.

Group Type: EXPERIMENTAL

Educational film and volitional help sheet

Intervention Type: 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™.

Interventions

Educational film and volitional help sheet

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Leeds Beckett University

OTHER

Sponsor Role: lead

Responsible Party

Trish Holch

Professor of Applied Health Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trish Holch, PhD

Role: PRINCIPAL_INVESTIGATOR

Leeds Beckett University

Locations

Leeds Beckett University

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

EVE/0032

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HOLCH_EVE_APPEAL

Identifier Type: -

Identifier Source: org_study_id