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

A multi-centred study of the effectiveness of PEGASUS: An intervention to promote shared decision making about breast reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18000391
Enrollment
180
Registered
2016-01-27
Start date
2016-01-11
Completion date
Unknown
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cancer

Interventions

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 br

Sponsors

University of the West of England, Bristol
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Breast Q (reconstruction) is measured pre-operatively and 3, 6 and 12 months post-operatively.

Secondary

MeasureTime frame
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

Countries

England, United Kingdom, Wales

Contacts

Public ContactNicole Paraskeva
Nicole.Paraskeva@uwe.ac.uk+44 (0)117 3287657

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026