Condition category
Cancer
Date applied
02/12/2013
Date assigned
16/01/2014
Last edited
12/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Ronan O'Carroll

ORCID ID

Contact details

Psychology
School of Natural Sciences
University of Stirling
Stirling
FK9 4LA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of a brief telephone reminder and support intervention to increase the uptake of breast cancer screening in women from socially deprived areas in Scotland

Acronym

TELBRECS

Study hypothesis

Our aim is to elicit and address barriers and facilitators to breast screening attendance in women from lower socioeconomic areas via a brief, personalised, telephone intervention, aimed at increasing screening uptake. We will also test whether asking questions about anticipated regret (AR) leads to additional increases in screening uptake, and examine whether this brief intervention is feasible and acceptable to low-income women.

Our research questions are:
1. Is a simple, telephone reminder intervention, aimed at eliciting and addressing the barriers and concerns of women in socially deprived areas regarding attending screening at the East of Scotland Breast Screening Service, feasible and acceptable to participants?
2. Can this brief, telephone intervention increase uptake in non-attenders from socially deprived areas?
3. Does adding anticipated regret to the telephone intervention have any additional benefit in terms of increasing uptake of screening in non-attenders?

Ethics approval

NHS Tayside, East of Scotland Research Ethics Service REC1, 04/11/2013, Ref: 13/ES/0128

Study design

Simple between groups four-arm prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

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

Condition

Breast cancer screening.

Intervention

Participants will be randomised to one of the four treatment groups:
1. Letter reminder (i.e., treatment as usual: Control)
2. Telephone reminder (TEL)
3. Telephone reminder plus telephone support (TEL-SUPP)
4. Telephone reminder plus support plus anticipated regret (TEL-SUPP-AR)

Letter reminder group (Control)
Participants randomised to the control group will receive the reminder letter only, as current practice.

All telephone groups (TEL, TEL-SUPP, TEL-SUPP-AR)
All telephone groups will receive the standard reminder letter in the same manner as the control group. Participants in each of the three telephone groups will also be telephoned by the Research Fellow from the University of Stirling.

Telephone reminder group (TEL)
The telephone reminder (TEL) will be a simple telephone call to remind non-attenders that they did not attend their scheduled appointment and provide information on how they can rearrange this appointment. Women wishing to rearrange their appointment will be given the option of being transferred directly to the appointments service at the Breast Screening Centre in Dundee.

Telephone support groups (TEL-SUPP and TEL-SUPP-AR)
Participants who are allocated to the telephone support intervention arms (TEL-SUPP and TEL-SUPP-AR) will be told that we are trying to understand why some women do not take up their invitation to attend for breast screening when invited and asked whether they would be prepared to answer some questions about breast screening. Those declining at this point would be assumed to have not given consent and would not be contacted further. The Patient Information Sheet would then be read out to prospective participants. This explains the nature and purpose of this research and reassures participants about the confidentiality and anonymity of their responses. They will also be given the option of being able to talk to a Health Psychologist, who is independent of this research. They will be asked whether they agree to take part now (Yes/No), or whether they would prefer to be phoned back later.

In both telephone support arms (TEL-SUPP and TEL-SUPP-AR), consenting patients will be asked to describe any reasons they had for not taking up the invitation to attend their appointment, and where appropriate, any barriers they mention will be addressed using a pre-specified list of responses, which will be generated from previous research. Any patient queries or concerns about the process of breast screening will also be addressed, using responses from existing materials. Whether or not specific barriers are mentioned by individuals will be recorded on a check-list of barriers generated from the existing research and previous telephone interviews. Any additional barriers mentioned will be added to this check-list.

Participants in the TEL-SUPP and TEL-SUPP-AR groups would also be asked to say whether they now intended to make an appointment to attend for breast screening.

Participants will be reassured throughout that it is their choice whether or not to take up their invitation to attend breast screening, but that the researcher is there to seek their views on attending and to provide them with additional help and information, should they wish to make another appointment to attend.

In order to check the acceptability and feasibility of the telephone support intervention, participants will be asked whether they minded being phoned up about breast screening, and also whether they found the telephone call helpful in addressing any concerns, queries or issues they might have regarding attending breast screening.

It is envisaged each phone call would last 5-10 minutes, although some may take longer, if a participant has a lot of issues she wants to discuss, and some would be shorter, if the participant does not mention any barriers or does not wish to take part. Women who express a desire to rearrange their appointment will be given the option of being transferred directly to the appointments service at the Breast Screening Centre in Dundee at the end of the telephone intervention.

Telephone support plus anticipated regret only (TEL-SUPP-AR)
In the TEL-SUPP-AR group, participants will receive exactly the same intervention as the TEL-SUPP condition, with the addition of two questions relating to Anticipated Regret, ‘If you didn’t make another appointment to attend for breast cancer screening, would you later wish you had?’; ‘If you didn’t attend for breast screening, would you later regret it?’.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Attendance at the breast screening service within 3 months of the reminder letter being sent out

Secondary outcome measures

1. Intention to make another appointment
2. Anticipated regret
3. Number of barriers to breast screening mentioned by participants
4. Specific barriers reported
5. To determine the likely effect size of the intervention

All of the secondary outcome measures are recorded at interview

Overall trial start date

01/12/2013

Overall trial end date

30/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female members of the Scottish general public who are invited to participate in the national breast screening programme and who do not attend their screening appointment
2. Aged between 50 and 70 years
3. The intervention will be targeted at lower income women; thus, only those from Scottish Index of Multiple Deprivation vigintiles 1-12 (representing the highest 60% of areas of deprivation) will be included

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

We will target 600 individuals (150 in each arm)

Participant exclusion criteria

1. Participants who have already telephoned to cancel or rebook their appointment for breast screening
2. Participants who, when telephoned, appear to have difficulty in understanding the intervention and/or appear unable to give verbal informed consent
3. Participants who have a medical reason for not attending breast screening (e.g., current breast cancer diagnosis)

Recruitment start date

01/12/2013

Recruitment end date

30/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Psychology, School of Natural Sciences
Stirling
FK9 4LA
United Kingdom

Sponsor information

Organisation

University of Stirling (UK)

Sponsor details

c/o Julia Campbell
Research and Enterprise Office
Stirling
FK9 4LA
United Kingdom

Sponsor type

University/education

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

NHS Tayside (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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25106506

Publication citations

  1. Protocol

    Chambers JA, O'Carroll RE, Cook A, Cavanagh J, Archibald D, Millar R, A pilot telephone intervention to increase uptake of breast cancer screening in socially deprived areas in Scotland (TELBRECS): study protocol for a randomised controlled trial., BMC Public Health, 2014, 14, 1, 824, doi: 10.1186/1471-2458-14-824.

Additional files

Editorial Notes