A brief TELephone intervention to increase uptake of BREast Cancer Screening (TELBRECS)
| ISRCTN | ISRCTN06039270 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06039270 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/12/2013
- Registration date
- 16/01/2014
- Last edited
- 05/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Prof Ronan O'Carroll
Scientific
Scientific
Psychology, School of Natural Sciences
University of Stirling
Stirling
FK9 4LA
United Kingdom
Study information
| Study design | Simple between groups four-arm prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study 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(s) | NHS Tayside, East of Scotland Research Ethics Service REC1, 04/11/2013, Ref: 13/ES/0128 |
| 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 didnt make another appointment to attend for breast cancer screening, would you later wish you had?; If you didnt attend for breast screening, would you later regret it?. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/12/2013 |
| Overall study end date | 30/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | We will target 600 individuals (150 in each arm) |
| 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 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
- Scotland
- United Kingdom
Study participating centre
Psychology, School of Natural Sciences
Stirling
FK9 4LA
United Kingdom
FK9 4LA
United Kingdom
Sponsor information
University of Stirling (UK)
University/education
University/education
c/o Julia Campbell
Research and Enterprise Office
Stirling
FK9 4LA
Scotland
United Kingdom
| Website | http://www.stir.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/045wgfr59 |
Funders
Funder type
Hospital/treatment centre
NHS Tayside (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/08/2014 | Yes | No | |
| Results article | results | 01/09/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
05/10/2018: Publication reference added.
