Decision Aid for Breast Reconstruction after Mastectomy: A Randomized Controlled Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28003

Enrollment

120

Registered

2019-08-06

Start date

2020-06-01

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

We developed a decision aid for breast reconstruction after mastectomy (validated in Dutch): https://www.keuzehulp.info/pp/type-borstreconstructie/intro, utilizing the Ottawa Decision Support Framewor

Eligibility

Inclusion criteria

Inclusion criteria: - Females. - Unilateral or bilateral mastectomy. - Oncologic mastectomy or prophylactic mastectomy. - Women that quality for a delayed or immediate breast reconstruction. - Sufficient computer skills. - Written informed consent.

Exclusion criteria

Exclusion criteria: - Patients < 18 years old. - History of breast reconstruction. - Prior visit to discuss breast reconstruction. - Previous access to an online decision aid per patient report after direct questioning. - Partial mastectomy or lumpectomy. - Metastatic disease at presentation. - Loco regional, distance or contralateral recurrence of illness or death before breast reconstruction. - Not being able to understand and speak the Dutch language sufficiently.

Design outcomes

Primary

Measure	Time frame
Decisional conflict (measured by the decisional conflict scale [DSC]) directly after the reconstructive decision	—

Secondary

Measure	Time frame
Immediately after the reconstructive decision: - Satisfaction with the visit on a 0-10 numerical scale - Satisfaction with information on a 0-10 numerical scale - Shared decision making questionnaire (SDM-Q-9) score - Treatment choice - Consultation time - Number of consultations - Patient-rated physician empathy (measured by CARE) - Symptoms of depression (measured by PROMIS Short Form Adult V1.0 item bank for depression) - Symptoms of anxiety (measured by PROMIS Short Form Adult V1.0 item bank for anxiety) At 12 - 14 months after reconstruction: - Decision regret (measured by the Decision Regret Scale [DRS]) - Decisional conflict (measured by the Decisional Conflict Scale [DCS]) - Satisfaction with information on a 0-10 numerical scale - Breast related satisfaction and quality of life (measured by BREAST-Q) - Subscale Body Image of the EORTC QLQ-BR23 - Subscale Breast Symptoms of the EORTC QLC-BR23 - Symptoms of depression (measured by PROMIS Short Form adult V1.0 item bank for depression) - Symptoms of anxiety (measured by PROMIS Short Form adult V1.0 item bank for anxiety) - Changes in treatment choice - Satisfaction with the treatment on a 0-10 numerical scale - Change in plastic surgeon	—

Measure

Time frame

Immediately after the reconstructive decision: - Satisfaction with the visit on a 0-10 numerical scale - Satisfaction with information on a 0-10 numerical scale - Shared decision making questionnaire (SDM-Q-9) score - Treatment choice - Consultation time - Number of consultations - Patient-rated physician empathy (measured by CARE) - Symptoms of depression (measured by PROMIS Short Form Adult V1.0 item bank for depression) - Symptoms of anxiety (measured by PROMIS Short Form Adult V1.0 item bank for anxiety) At 12 - 14 months after reconstruction: - Decision regret (measured by the Decision Regret Scale [DRS]) - Decisional conflict (measured by the Decisional Conflict Scale [DCS]) - Satisfaction with information on a 0-10 numerical scale - Breast related satisfaction and quality of life (measured by BREAST-Q) - Subscale Body Image of the EORTC QLQ-BR23 - Subscale Breast Symptoms of the EORTC QLC-BR23 - Symptoms of depression (measured by PROMIS Short Form adult V1.0 item bank for depression) - Symptoms of anxiety (measured by PROMIS Short Form adult V1.0 item bank for anxiety) - Changes in treatment choice - Satisfaction with the treatment on a 0-10 numerical scale - Change in plastic surgeon

—

Contacts

Public ContactClaudia Bargon

St. Antonius Nieuwegein

c.bargon@antoniusziekenhuis.nl0653952756

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026