Menopause care and shared decision-making after breast cancer
| ISRCTN | ISRCTN13759134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13759134 |
- Submission date
- 04/07/2023
- Registration date
- 14/07/2023
- Last edited
- 10/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Breast cancer affects 1 in 9 UK women. Breast cancer treatment can trigger early menopause and/or more severe menopause symptoms compared with natural menopause. Hormone replacement therapy (HRT) effectively treats menopausal symptoms but is not recommended for breast cancer survivors due to recurrence concerns. Non-hormonal treatments target specific symptoms but do not improve the overall quality of life or reduce long-term health risks as HRT does. The risk of recurrence with HRT is uncertain, but many women would still consider it for symptom relief and improved quality of life. Patient dissatisfaction with menopause care after breast cancer is high, and HRT is currently limited to exceptional cases. This study aims to assess the needs and experiences of UK breast cancer survivors to inform clinicians, and policymakers, and raise awareness.
Who can participate?
Women aged 18 to 70 years with a history of breast cancer and resident in the UK
What does the study involve?
Women will be invited to complete a survey that will be advertised on menopause and breast cancer charity social media sites. The survey is anonymous and takes around 20 minutes to complete. Women will be asked about their experience of menopause care since their breast cancer diagnosis. If women change their minds and wish to withdraw consent, they can simply close the survey without submitting their completed responses.
What are the possible benefits and risks of participating?
Breast cancer is an upsetting experience. Not being listened to is also upsetting. We hope that participating patients who may be struggling with menopause symptoms and/or having difficulty accessing menopause care will be given a voice and feel able to air their views and concerns. If found to be lacking, it is hoped that the survey results can be used to raise awareness about the unmet needs of breast cancer survivors and improve menopause care in this patient group. This will benefit all breast cancer survivors. There are no risks to patients who consent to participate.
The survey will be hosted on the secure and GDPR-approved University College London Qualtrics Survey Platform. This means that the survey is anonymous and the results can only be seen by the researchers.
Where is the study run from?
Newson Health Ltd (UK)
When is the study starting and how long is it expected to run for?
January 2023 to January 2024. The survey will launch in August 2023 and will be open for two months.
Who is funding the study?
Newson Health Ltd (UK)
Who is the main contact?
Dr Sarah Glynne, Sarah.glynne@newsonhealth.co.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-how-women-receive-information-make-decision-about-their-menopause-care-after-breast-cancer#undefined
Contact information
Principal Investigator
Claire Mellon & Associates
Portland Hospital
212 Great Portland Street
London
W1W 5QN
United Kingdom
| Phone | +44 (0)20 7390 6225 |
|---|---|
| sarah.glynne@newsonhealth.co.uk |
Scientific
Claire Mellon & Associates
Portland Hospital
212 Great Portland Street
London
W1W 5QN
United Kingdom
| Phone | +44 (0)20 7390 6225 |
|---|---|
| sarah.glynne@newsonhealth.co.uk |
Public
Claire Mellon & Associates
Portland Hospital
212 Great Portland Street
London
W1W 5QN
United Kingdom
| Phone | +44 (0)20 7390 6225 |
|---|---|
| sarah.glynne@newsonhealth.co.uk |
Study information
| Study design | Observational cross-sectional survey study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Community, Internet/virtual |
| Study type | Quality of life, Treatment |
| Participant information sheet | The participant information sheet is accessible by clicking the link to the online survey. Women are automatically directed to the information sheet and consent form, and can't proceed to the survey until they have ticked that they understand the information and consent to participate. |
| Scientific title | Menopause care and shared decision-making after breast cancer: a UK-based cross-sectional study |
| Study objectives | Breast cancer patients are more likely to struggle with menopause symptoms and have fewer treatment options compared with cancer-free women. Very limited evidence suggests that many breast cancer survivors suffer from debilitating symptoms but struggle to access menopause care and support. We wish to explore the scale of the problem and the types of issues that breast cancer survivors face. We hope that this will inform higher quality menopause care for women after breast cancer in the future. |
| Ethics approval(s) |
Approved 13/06/2023, UCL Research Ethics Committee (Office of the Vice Provost (Research), University College London, 2 Taviton Street, London, WC1E 6BT, United Kingdom; +44 (0)20 7679 8717; ethics@ucl.ac.uk), ref: 9093/005 |
| Health condition(s) or problem(s) studied | Menopause care in breast cancer survivors |
| Intervention | Breast cancer survivors will be invited to participate in an on-line survey that will be advertised on various breast cancer and menopause social media sites. The survey includes questions about symptoms, quality of life, menopause care including shared decision making (using the validated 9-item Shared Decision-Making Questionnaire (SDM-Q-9), and patient views and attitudes. The survey is anonymous and takes 15-20 minutes to complete. The survey will be hosted on the secure and GDPR-approved UCL Quailtrics Survey Platform. |
| Intervention type | Other |
| Primary outcome measure | Patient involvement in menopause treatment shared decision-making after breast cancer measured using the Shared Decision-Making Questionnaire (SDM-Q-9) at one timepoint |
| Secondary outcome measures | 1. The nature and severity of unmet needs in breast cancer survivors 2. Breast cancer survivor's views and attitudes about HRT after breast cancer 3. Breast cancer survivor's experience of menopause care in the UK All secondary outcome measures will be assessed using survey questions designed by the research team at one timepoint. |
| Overall study start date | 01/01/2023 |
| Completion date | 01/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | 500 to 1000 |
| Total final enrolment | 1718 |
| Key inclusion criteria | Women with a history of breast cancer aged 18-70 years and resident in the UK |
| Key exclusion criteria | 1. Women without breast cancer 2. Women aged <18 or >70 years 3. Men 4. Non-UK resident |
| Date of first enrolment | 01/08/2023 |
| Date of final enrolment | 01/10/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Church St
Stratford-upon-Avon
CV37 6HB
United Kingdom
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| Phone | +44 (0)207 679 2000 |
|---|---|
| ethics@ucl.ac.uk | |
| Website | https://www.ucl.ac.uk/womens-health/institute-womens-health |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | This is an anonymous survey so there we will have no way to disseminate the results of the study with participants directly. However, we will share the results on Newson Health's social media as well as via our breast cancer charity partners. In turn, they will publicise the findings. Data collected will be submitted for peer review and if published, a link to the published results will be also shared with participants via the same channels that were used during recruitment. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository. Data will be stored securely on password-protected UCL N hard drives during the period of the project for the purposes of data analysis. Computer storage will be in G12, Paul O’Gorman Building, Huntley Street, WC1EE 6BT. Any excess data not required for publication will be deleted. Project data will be kept for purposes of verification/peer review/further analysis as required, for a maximum of 10 years, after which it will be deleted. |
Editorial Notes
10/01/2024: Total final enrolment added.
08/08/2023: The following changes have been made:
1. The sponsor was changed from UCL Institute of Women's Health to University College London.
2. Cancer Research UK plain English summary link added to plain English summary field
06/07/2023: Trials' existence confirmed by UCL Research Ethics Committee (UK).
