Condition category
Cancer
Date applied
27/01/2016
Date assigned
27/01/2016
Last edited
24/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

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
+44 117 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 below 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 measures

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

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

Sponsor information

Organisation

University of the West of England, Bristol

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Breast Cancer Campaign

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review. 03/02/2016: Verified study information with principal investigator.