Condition category
Cancer
Date applied
14/05/2013
Date assigned
06/06/2013
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study of 3,000 young people and 1,500 of their parents/carers to find out whether hearing about cancer in school increases young people’s and their parents’/carers’ cancer awareness and whether families talk more about cancer at home. The study’s findings will help teenage cancer charities and governments across the UK and elsewhere around the world to decide whether education about cancer should be delivered in other schools as part of the curriculum.

Who can participate?
The study aims to recruit 3,000 adolescents and 1,500 of their parents/carers from 20 secondary schools in Glasgow, Scotland. Young people involved in the study are in their second year of secondary school (S2) and are 12-13 years old. Parents/carers can take part if their child is involved in the study.

What does the study involve?
Schools will be randomly allocated so that students in half of the schools will receive a lesson about cancer in August/September 2013 (the intervention schools) and the other half will receive a lesson about cancer in August/September 2014 (the control schools). Young people in the 10 intervention schools and their parents/carers will complete a questionnaire that asks them about their cancer awareness and family communication about cancer in June 2013 and then, again, two weeks and six months after they have taken part in a lesson about cancer. Young people in the 10 control schools and their parents/carers will complete the same questionnaires at the same time points as the students and parents/carers in the intervention schools. Only after they have completed the final questionnaire will students in the 10 control schools receive a lesson about cancer. We are doing this so that we can compare the impact of education about cancer between groups of young people and their parents/carers who have received a lesson about cancer with a group of young people and their parents/carers who had not received a lesson about cancer at that time.

What are the possible benefits and risks of participating?
There is no immediate direct benefit to those taking part. However, our previous research indicated that the lesson about cancer raised cancer awareness, which may mean that young people are more likely to know and be able to identify the signs and symptoms of cancer, which may help them during adolescence and in later life. The main risk is that the study raises anxiety around cancer among young people and their parents/carers. At the moment, we do not know whether this will be the case so we are measuring anxiety as part of the study to find this out.

Where is the study run from?
The study has been set up by the Cancer Care Research Centre at the University of Stirling and is being run in collaboration with Teenage Cancer Trust, a UK teenage and young adult (TYA) cancer charity who are delivering the lesson about cancer in schools.

When is the study starting and how long is it expected to run?
The study started in April 2013 and will run until June 2014.

Who is funding the study?
Teenage Cancer Trust and the Scottish Government’s Detect Cancer Early Programme.

Who is the main contact?
Dr Gill Hubbard
gill.hubbard@stir.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gill Hubbard

ORCID ID

Contact details

Cancer Care Research Centre
School of Nursing
Midwifery and Health
University of Stirling
Stirling
FK9 4LA
United Kingdom
-
gill.hubbard@stir.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Adolescent Cancer Education (ACE): a two-arm pragmatic cluster randomised controlled trial to assess the effectiveness of a secondary school-based educational intervention to increase adolescents' and parents'/carers' cancer awareness and family cancer communication

Acronym

ACE

Study hypothesis

The study aims to determine the effectiveness of a secondary school-based educational intervention on:
1. adolescents’ cancer awareness
2. parents’/carers’ cancer awareness
3. family cancer communication

Ethics approval

The study was reviewed and approved by the School Research Ethics Committee (SREC) in the School of Nursing, Midwifery and Health, University of Stirling, UK, 20/03/13

Study design

Two-arm cluster randomised controlled trial (RCT)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer awareness

Intervention

The intervention comprises two key components: 1) a one hour verbal and visual presentation delivered by a Teenage Cancer Trust educator to adolescents in school, and; 2) provision of a parent-adolescent homework activity.
1. Presentation:
The adolescent component comprises a verbal and visual presentation delivered by a Teenage Cancer Trust educator with 3.5 years’ experience of delivering the intervention in secondary schools. The educator will deliver the presentation to a whole year group on school premises (e.g., large hall) during school time. The presentation is 50-60 minutes in duration, with variation within this timeframe to accommodate differences in the school timetable. The presentation encourages interaction between the educator and students through the use of a true or false quiz and open questions to the audience. The educator will also utilise video clips to inform adolescents about: cancer signs, symptoms, diagnosis and treatment; its emotional impact; and how young people can reduce their risk of developing cancer in the future.
2. Homework activity:
The parental component comprises a homework sheet given to pupils at the end of the presentation to take home and complete with a parent/carer. The pupils will be encouraged to ask their parent/carer six questions relating to cancer and have a discussion with them around these questions. This is designed to encourage conversations about the Teenage Cancer Trust presentation which may subsequently raise parents’ cancer awareness.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Cancer awareness: assessed at baseline (June 2013), 2 weeks and 6 months later in intervention schools and at the same time points in control schools. All outcome measurement instruments will be combined into single and separate self-completion paper questionnaires for adolescents and parents. Adolescent questionnaires will be administered by teachers in the classroom. Teachers will be available to answer any queries and to assist the students with reading and writing as necessary. Students will be asked to complete the questionnaire in complete silence but will be informed that it is not a test. Parent questionnaires will be sent home from and returned to school with adolescents. Trial researchers will be available by telephone and email to answer any queries parents may have when completing the questionnaire.

Secondary outcome measures

1. Family Cancer Communication
2. Health-related Behaviours
3. Anxiety

Adolescent outcomes will be assessed at three timepoints:
1. Baseline (T0), when adolescents are in school year S1
2. Two-week follow-up (T1), when adolescents are in the first term of S2
3. Six-month follow-up (T2), when adolescents are in the second term of S2
Parent outcomes will be assessed at baseline (T0) and 2-week follow-up (T1).

Overall trial start date

01/04/2013

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. School students in Secondary 2 (aged 12-13) enrolled in schools run by Glasgow city council local authority.
2. Parents/carers of school students recruited to the study

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

3,000 Adolescents and 1,500 Parents/Carers.

Participant exclusion criteria

School students in Secondary 2 enrolled in independent (private) schools within Glasgow city council local authority area

Recruitment start date

01/04/2013

Recruitment end date

30/06/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Care Research Centre
Stirling
FK9 4LA
United Kingdom

Sponsor information

Organisation

University of Stirling (UK)

Sponsor details

Research and Enterprise Office
University of Stirling
Stirling
FK9 4LA
United Kingdom
-
carol.johnstone@stir.ac.uk

Sponsor type

University/education

Website

http://www.stir.ac.uk/

Funders

Funder type

Charity

Funder name

Teenage Cancer Trust (UK) and Scottish Government Detect Cancer Early Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24011093

Publication citations

  1. Protocol

    Kyle RG, Macmillan I, Rauchhaus P, O'Carroll R, Neal RD, Forbat L, Haw S, Hubbard G, Adolescent Cancer Education (ACE) to increase adolescent and parent cancer awareness and communication: study protocol for a cluster randomised controlled trial., Trials, 2013, 14, 286, doi: 10.1186/1745-6215-14-286.

Additional files

Editorial Notes