Topic: Cancer
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Breast Q (reconstruction) is measured pre-operatively and 3, 6 and 12 months post-operatively. | — |
Secondary
| Measure | Time 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