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 designNon-randomised; Interventional; Design type: Process of Care
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA multi-centred study of the effectiveness of PEGASUS: An intervention to promote shared decision making about breast reconstruction
Study acronymPEGASUS
Study objectivesThe 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) studiedTopic: Cancer; Subtopic: Breast Cancer; Disease: Breast
InterventionAll 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 typeOther
Primary outcome measureBreast Q (reconstruction) is measured pre-operatively and 3, 6 and 12 months post-operatively.
Secondary outcome measures1. 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 date11/01/2016
Completion date30/06/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsPlanned Sample Size: 180; UK Sample Size: 180
Total final enrolment147
Key inclusion criteria1. 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 criteria1. 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 enrolment11/01/2016
Date of final enrolment31/10/2017

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 logo "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 date31/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination plan1. 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 planNot 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.