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

Plain English Summary

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

Study website

Type

Public

Contact name

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

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

19624

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(s)

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

Study setting(s)

Other

Study 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

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

Overall study end date

30/06/2019

Reason abandoned (if study stopped)

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(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

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

Countries of recruitment

England, United Kingdom, Wales

Study participating centre

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

Study participating centre

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

Study participating centre

Royal Cornwall Hospital
2 Penventinnie Lane
Treliske
Truro
TR1 3LQ
United Kingdom

Study participating centre

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

Study participating centre

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

Organisation

University of the West of England, Bristol

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

ROR

https://ror.org/02nwg5t34

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

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

Individual participant data (IPD) sharing plan

Not provided at time of registration

IPD sharing plan summary

Available on request

Study outputs