Evaluation of information provision about fertility sparing treatments for women with breast cancer.

Effect evaluation of a Decision Aid for Fertility Preservation in Women with Breast cancer: A Randomized Controlled Trial in the Netherlands.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26732

Enrollment

400

Registered

2011-08-17

Start date

2011-06-06

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

Young premenopausal women (18-40) with breast cancer at risk for premature ovarian failure (POF)

Interventions

Information provision trough a Webbased decision aid (intervention) about fertility preservation compared to general patient brochures (control) about fertility preservation. The effect of the interve

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women; 2. 18-40 years old; 3. Diagnosed with breast cancer; 4. Will soon start their breast cancer treatment; 5. Eligible for FP; 6. Have an email address.

Exclusion criteria

Exclusion criteria: No sufficient knowledge of the Dutch language.

Design outcomes

Primary

Measure	Time frame
(Measured with a questionnaire). Decisional conflict as measured with the decisional conflict scale (DCS, O'connor, 1995).	—

Secondary

Measure	Time frame
(All measured with questionnaires). Satisfaction with decision making (subscale dcs), preparation for decision making (Bennet et al 2010), decisional regret (Brehaut et al 2003), reproductive concerns (Wenzel et al 2005), risk perception, knowledge, attitude, preference/uptake, health literacy (Chew et al 2004), anxiety and depression (Hospital Anxiety and Depression Scale), quality of life (EORTC-QLQ-C30).	—

Measure

Time frame

(All measured with questionnaires). Satisfaction with decision making (subscale dcs), preparation for decision making (Bennet et al 2010), decisional regret (Brehaut et al 2003), reproductive concerns (Wenzel et al 2005), risk perception, knowledge, attitude, preference/uptake, health literacy (Chew et al 2004), anxiety and depression (Hospital Anxiety and Depression Scale), quality of life (EORTC-QLQ-C30).

—

Contacts

Public ContactMirjam M. Garvelink

Leiden University Medical Center (LUMC) Department of gynecology - Poortgebouw Zuid (VRSP) P/O Box 9600

m.m.garvelink@lumc.nl+31 (0)71 5261545

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)