The minimal clinically important difference for decisional conflict, impact of event, body image scale and the Short Form-36 among women with breast cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22847

Enrollment

120

Registered

2020-02-25

Start date

2020-02-25

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Breast cancer

Interventions

Consenting subjects are invited to fill out a panel of standardized questionnaires, including the DCS, IES, BIS, SF-36, PROMIS Short Form Anxiety and Depression, PCS, GSE (self-efficacy), and a study

Eligibility

Inclusion criteria

Inclusion criteria: - Women with the diagnosis of in situ or invasive breast cancer visiting the outpatient clinic of the oncological surgery department in the St. Antonius Hospital. - Indication for surgical treatment. - Written informed consent.

Exclusion criteria

Exclusion criteria: - History of breast cancer. - No indication for surgery. - Age < 18 years old. - Not being able to understand and speak the Dutch language sufficiently.

Design outcomes

Primary

Measure	Time frame
Difference in Decisional conflict scale (DCS) score before and 2 - 4 weeks after surgical decision.	—

Secondary

Measure	Time frame
- Difference in Impact of event scale (IES) score before and 4 - 6 weeks/6 months after surgical decision. - Difference in Body Image after Breast Cancer Questionnaire (BIS) before and 4 - 6 weeks/6 months after surgical decision. - Difference in Short form 36 Health Survey Questionnaire (SF-36) before and 4 - 6 weeks/6 months after surgical decision.	—

Contacts

Public ContactClaudia Bargon

St. Antonius Nieuwegein

c.bargon@antoniusziekenhuis.nl0031653952756

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)