PEGASUS: The effectiveness of an intervention designed to promote shared decision making about breast reconstruction

ISRCTN	ISRCTN18000391
DOI	https://doi.org/10.1186/ISRCTN18000391
Secondary identifying numbers	19624

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-a-new-way-to-help-women-decide-about-breast-reconstructive-surgery-pegasus

Contact information

Ms Nicole Paraskeva
Public

University of the West of England
Frenchay Campus
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom

Phone	+44 (0)117 3287657
Email	Nicole.Paraskeva@uwe.ac.uk

Study information

Study design	Non-randomised; Interventional; Design type: Process of Care
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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	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 study start date	11/01/2016
Completion date	30/06/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned Sample Size: 180; UK Sample Size: 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

England
United Kingdom
Wales

Study participating centres

Royal Hampshire County Hospital

Hampshire Hospitals NHS Foundation Trust
Romsey Road
Winchester
SO22 5DG
United Kingdom

Royal United Hospital

Royal United Hospitals Bath NHS Foundation Trust
Combe Park
Bath
BA1 3NG
United Kingdom

Royal Cornwall Hospital

2 Penventinnie Lane
Treliske
Truro
TR1 3LQ
United Kingdom

Southmead Hospital

North Bristol NHS Trust
Southmead Way
Bristol
BS10 5NB
United Kingdom

University Hospital Wales

Cardiff and Vale University Health Board
Health Park
Cardiff
CF14 4XW
United Kingdom

Sponsor information

University of the West of England, Bristol
Hospital/treatment centre

University of the West of England
Frenchay Campus
Coldharbour Lane
Bristol
BS16 1QY
England
United Kingdom

"ROR"	https://ror.org/02nwg5t34

Funders

Funder type

Charity

Breast Cancer Campaign
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Plain English results			18/05/2022	No	Yes
Results article		15/11/2021	14/11/2022	Yes	No

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.