PEGASUS: The effectiveness of an intervention designed to promote shared decision making about breast reconstruction
| ISRCTN | ISRCTN18000391 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18000391 |
| Protocol serial number | 19624 |
| Sponsor | University of the West of England, Bristol |
| Funder | Breast Cancer Campaign |
- Submission date
- 27/01/2016
- Registration date
- 27/01/2016
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Public
University of the West of England
Frenchay Campus
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom
| Phone | +44 (0)117 3287657 |
|---|---|
| Nicole.Paraskeva@uwe.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Interventional; Design type: Process of Care |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A multi-centred study of the effectiveness of PEGASUS: An intervention to promote shared decision making about breast reconstruction |
| Study acronym | PEGASUS |
| Study objectives | The aim of this study is to evaluate the impact and cost effectiveness of a patient-centred, goal-focused intervention to support shared decision making for women contemplating breast reconstruction. |
| Ethics approval(s) | National Research Ethics Service Committee South Central - Berkshire B, 01/07/2015, ref: 15/SC/033 |
| Health condition(s) or problem(s) studied | Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast |
| Intervention | All participants are invited to take part in PEGASUS. This involves meeting a decision facilitator (specialist nurse/psychologist trained in its use) during which the patient elicits her individual breast reconstruction goals, what would indicate a successful outcome and the importance of each goal. The PEGASUS intervention can last between 20 minutes to an hour, depending on the participant. Participants take the completed PEGASUS sheet into the surgical consultation where it is used to set shared goals and promote concordance between the patient and surgeon so they approach surgery as a shared endeavor. PEGASUS facilitates the disclosure and discussion of expectations, enabling the surgeon to decide the extent to which they are realistic and if necessary take appropriate steps to address unrealistic expectations. Data will be collected from at the time of decision making, and then 3, 6 and 12 months after surgery. Health professionals and a purposefully selected sample of participants will be interviewed about whether their expectations of reconstruction were met and their experiences of PEGASUS (if appropriate). |
| Intervention type | Other |
| Primary outcome measure(s) |
Breast Q (reconstruction) is measured pre-operatively and 3, 6 and 12 months post-operatively. |
| Key secondary outcome measure(s) |
1. Regret is measured using the Decisional Regret Scale at 3, 6 and 12 months post-operatively |
| Completion date | 30/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 180 |
| Total final enrolment | 147 |
| Key inclusion criteria | 1. Women over the age of 18 2. Those who have been offered the option of immediate or delayed breast reconstruction (any type) because they have been diagnosed as having breast cancer or Ductal Carcinoma in Situ (DCIS), or are undergoing risk-reducing mastectomy |
| Key exclusion criteria | 1. Those who are unsuitable for breast reconstruction 2. Insufficient grasp of English to participate in an intervention and study conducted in English |
| Date of first enrolment | 11/01/2016 |
| Date of final enrolment | 31/10/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centres
Romsey Road
Winchester
SO22 5DG
United Kingdom
Combe Park
Bath
BA1 3NG
United Kingdom
Treliske
Truro
TR1 3LQ
United Kingdom
Southmead Way
Bristol
BS10 5NB
United Kingdom
Health Park
Cardiff
CF14 4XW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/11/2021 | 14/11/2022 | Yes | No | |
| Protocol article | protocol | 02/10/2017 | Yes | No | |
| Other publications | intervention design | 01/01/2020 | 30/01/2020 | Yes | No |
| Other publications | patients' and health professionals' experiences | 24/05/2021 | 25/05/2021 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 18/05/2022 | No | Yes |
Editorial Notes
14/11/2022: Publication reference added.
18/05/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
25/05/2021: Publication reference added.
30/01/2020: Publication reference added.
04/10/2017: Publication reference added.
26/06/2017: Added University Hospital Wales as a trial participating site.
13/01/2017: Cancer Help UK lay summary link added to plain English summary field.
03/02/2016: Verified study information with principal investigator.
