Support for lifestyle behaviour change after breast cancer treatment
| ISRCTN | ISRCTN14717202 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14717202 |
| IRAS number | 332207 |
| Secondary identifying numbers | CPMS 57719, NIHR206118, IRAS 332207 |
- Submission date
- 02/07/2024
- Registration date
- 12/08/2024
- Last edited
- 11/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Breast cancer is the most common cancer. More than half of people who have breast cancer weigh more than a healthy weight. When people weigh more than a healthy weight, cancer treatments may not work as well, and breast cancer is more likely to return after treatment. It is recommended that patients with breast cancer do regular exercise and eat healthy foods. For those who have excess weight it is suggested that they try to lose between 5% and 10% of their body weight. Activities which help people lose weight can improve quality of life and mental health. Examples of these activities are eating healthily, exercising and accessing psychological (therapy) support. However, there is no clear way to help people with breast cancer do this, and different activities are provided in different places. We also need to know more about what people with breast cancer do if they are offered support.
This study aims to describe what lifestyle and behaviour change support is offered by the NHS to breast cancer survivors after their diagnosis or during their treatment, and to understand what helps or hinders health services offering support or patients taking up support.
Who can participate?
Breast care nurses and cancer navigators working in NHS Trusts across England, and breast cancer patients who have been diagnosed up to 12 months before the study at one of five participating NHS Trust study sites.
What does the study involve?
The study involves exploring what activities to lose weight and help with lifestyle change are offered to people with breast cancer by NHS services. We will also look at what activities they do. We will do this by sending surveys to breast care nurses working across England and people diagnosed with breast cancer within the last 12 months from five selected NHS Trusts across England. We will also carry out interviews with around 20 nurses and 20 people with breast cancer to talk about their experiences in more detail. At the end of the study, we will bring together the information from the surveys and interviews and have an event to discuss our results with people working in health services and patients, to learn what works well and what doe not work well for breast cancer patients and services.
What are the possible benefits and risks of participating?
There are no anticipated risks to taking part in this study. Participants who complete a survey will be offered a £20 voucher to thank them for their time. Those who go on to participate in a semi-structured interview will receive an additional £20 voucher to thank them for taking part.
Where is the study run from?
The University of Birmingham and Shrewsbury and Telford NHS Trust (UK)
When is the study starting and how long is it expected to run for?
June 2024 to November 2025
Who is funding the study?
The National Institute for Health and Care Research (NIHR) Research for Patient Benefit (RfPB) programme (UK)
Who is the main contact?
Dr Sarah Damery; s.l.damery@bham.ac.uk
Contact information
Public, Scientific
Institute of Applied Health Research, Murray Learning Centre, University of Birmingham
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0003-3681-8608 |
|---|---|
| Phone | +44 (0)1214143343 |
| s.l.damery@bham.ac.uk |
Study information
| Study design | Observational cross-sectional |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Understanding the offer and uptake of support for lifestyle behaviour change following breast cancer treatment |
| Study objectives | Eating healthily, undertaking physical activity and accessing wellbeing support (together termed as lifestyle behaviour change support (LBCS)) may improve quality of life, response to treatment and mental health for people diagnosed with breast cancer. However, we do not know what support patients are offered by healthcare services, what activities patients do, and what the barriers and facilitators to the offer/uptake of LBCS are. These issues need to be explored with both healthcare staff and patients. |
| Ethics approval(s) |
Approved 02/08/2024, Wales Research Ethics Committee 5 (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2071048197; Wales.REC5@wales.nhs.uk), ref: 24/WA/0201 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | This mixed methods study will combine three work packages. 1. Work package 1 will focus on collecting quantitative data via surveys of healthcare professionals (breast cancer nurses/cancer navigators) working in NHS Trusts across England. Any individuals who choose to complete the survey will be participants in the research for up to 20 minutes, which is the estimated completion time for the survey. WP1 will also include surveys of breast cancer patients who had been diagnosed 12 months previously. Patients at five participating NHS Trust research sites will be sent the survey for completion by the direct care team at the Trust. Those who choose to complete it will be participants in the research for up to 20 minutes, which is the estimated completion time for the survey. 2. Work package 2 will use semi-structured interviews (qualitative data collection) with breast cancer nurses/cancer navigators (up to 20 interviews). Interview participants will be drawn from the pool of respondents to the survey in WP1 and will be approached to participate in an interview if they had indicated on their survey return that they may be interested in being interviewed. Participants will be interviewed once, for up to 45 minutes. Work package 2 will also use semi-structured interviews with patients (up to 20 interviews). Interview participants will be purposively sampled from the pool of respondents to the survey from WP1 and will be approached to participate in an interview if they had indicated on their survey return that they may be interested in being interviewed. Participants will be interviewed once, for up to 45 minutes. For healthcare professionals/patients who wish to participate in the survey only, their participation in the research will last for up to 20 minutes. For healthcare professionals/patients who participate in the survey and an interview, their participation in the research will last for up to 70 minutes in total (including time for taking consent at the start of any interview). 3. Work package 3 will being together the data from WP1 and WP2 and there will be a stakeholder workshop to identify recommendations from the research about how lifestyle and behaviour change support for people with breast cancer could/should be offered. |
| Intervention type | Other |
| Primary outcome measure | Factors that explain the offer and/or uptake of lifestyle and behaviour change support activities by patients with breast cancer measured using semi-structured interviews at a single time point |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/06/2024 |
| Completion date | 30/11/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 670; UK Sample Size: 670 |
| Key inclusion criteria | Work package 1 (healthcare staff) 1.1. Breast cancer nurses/cancer navigators currently working in breast care services in the NHS across England 1.2. Breast cancer nurses/cancer navigators who have regular contact with breast cancer patients and who engage in treatment discussions 1.3. Aged 18+ years Work package 1 (patients) 1.4. Aged 18+ years 1.5. Patients diagnosed with early or locally-advanced breast cancer within the previous 12 month period who will be between 6-12 months post-diagnosis at the time the survey is administered 1.6. Treated at any of five participating NHS Trust sites Work package 2 (healthcare professionals) 2.1. Respondents to the WP1 survey who indicated they would be interested in being interviewed Work package 2 (patients) 2.2. Respondents to the WP1 survey who indicated they would be interested in being interviewed |
| Key exclusion criteria | Work package 1 (healthcare staff) 1.1. Breast cancer nurses/cancer navigators who are not currently working in breast care services in the NHS across England 1.2. Breast cancer nurses/cancer navigators who do not have regular contact with breast cancer patients and do not engage in treatment discussions Work package 1 (patients) 1.3. Unable to consent to take part, as determined by clinical review of patient lists at participating NHS sites before survey packs are sent 1.4. Unable to take part in a survey for any other reason (e.g. mental health issues), as determined by clinical review of patient lists at participating NHS sites before survey packs are sent |
| Date of first enrolment | 01/09/2024 |
| Date of final enrolment | 31/05/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Shrewsbury
SY3 8XQ
United Kingdom
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Sponsor information
Hospital/treatment centre
Mytton Oak Road
Shrewsbury
SY3 8XQ
England
United Kingdom
| Phone | +44 7703388049 |
|---|---|
| joanne.sawyer1@nhs.net | |
| Website | https://www.sath.nhs.uk/ |
"ROR" |
https://ror.org/047feaw16 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/11/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Sarah Damery, s.l.damery@bham.ac.uk once the study has completed in November 2025 for up to 3 years after study conclusion. Deanonymised survey data and deanomymised qualitative interview transcripts will be made available to bona fide researchers for the purposes of quantitative or qualitative analysis as long as suitable permissions are obtained for data analysis. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.0 | 01/08/2024 | 12/09/2024 | No | No |
Additional files
Editorial Notes
11/03/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2025 to 31/05/2025.
2. The study participating centre Guy's and St Thomas' NHS Foundation Trust was removed.
12/09/2024: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The ethics approval was added.
3. The participant level data sharing statement was added.
02/07/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
