Contact information
Type
Public
Primary contact
Ms Nicole Paraskeva
ORCID ID
Contact details
University of the West of England
Frenchay Campus
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom
+44 (0)117 3287657
Nicole.Paraskeva@uwe.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
19624
Study information
Scientific title
A multi-centred study of the effectiveness of PEGASUS: An intervention to promote shared decision making about breast reconstruction
Acronym
PEGASUS
Study hypothesis
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
National Research Ethics Service Committee South Central - Berkshire B, 01/07/2015, ref: 15/SC/033
Study design
Non-randomised; Interventional; Design type: Process of Care
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
Breast Q (reconstruction) is measured pre-operatively and 3, 6 and 12 months post-operatively.
Secondary outcome measures
1. Regret is measured using the Decisional Regret Scale at 3, 6 and 12 months post-operatively
2. Health related quality of life is measured using the EQ5DL and ICECAP-A questionnaires pre-operatively and 3, 6 and 12 months post operatively
3. Health economic measures are measured at 3, 6 and 12 months post operatively
4. Shared decision making is measured using the decisional conflict scale, VAS items and CollaboRATE pre-operatively
Overall trial start date
11/01/2016
Overall trial end date
30/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 180; UK Sample Size: 180
Participant 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
Recruitment start date
11/01/2016
Recruitment end date
31/10/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Hampshire County Hospital
Hampshire Hospitals NHS Foundation Trust
Romsey Road
Winchester
SO22 5DG
United Kingdom
Trial participating centre
Royal United Hospital
Royal United Hospitals Bath NHS Foundation Trust
Combe Park
Bath
BA1 3NG
United Kingdom
Trial participating centre
Royal Cornwall Hospital
2 Penventinnie Lane
Treliske
Truro
TR1 3LQ
United Kingdom
Trial participating centre
Southmead Hospital
North Bristol NHS Trust
Southmead Way
Bristol
BS10 5NB
United Kingdom
Trial participating centre
University Hospital Wales
Cardiff and Vale University Health Board
Health Park
Cardiff
CF14 4XW
United Kingdom
Funders
Funder type
Charity
Funder name
Breast Cancer Campaign
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. Planned publication of the study protocol and results in peer-reviewed, open access journals
2. Planned presentation of results at national and international conferences
Intention to publish date
31/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/28969622
2020 intervention design in https://www.ncbi.nlm.nih.gov/pubmed/31994007 (added 30/01/2020)