(Cost-) effectiveness of online self-help training for fear of cancer recurrence in breast cancer patients.

Completed

Conditions: angst voor de terugkeer van kanker
fear of cancer recurrence
10002861

Registration Number: NL-OMON41426

Lead Sponsor: Helen Dowling Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 454

Inclusion Criteria

- Female
- Diagnosis of breast cancer, between one and five years ago (part A)
- No signs for local/regional recurrence or metastatic disease (part A)
- Capable of filling out questionnaires in Dutch (part A)
- Age at disease onset at least 18 years old (part A)
- Access to the internet (part B)

Exclusion Criteria

- No exclusion criteria

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure will be fear of cancer recurrence. Fear of cancer<br /><br>recurrence will be assessed with the Fear of Cancer Recurrence Inventory<br /><br>(FCRI). The FCRI consist of the following seven subscales: triggers, severity,<br /><br>psychological distress, coping strategies, functioning impairments, insight,<br /><br>and reassurance. The severity-subscale is the first outcome measure in this<br /><br>study. The coping strategies- and functioning impairments-scale scores at<br /><br>baseline will be used in the predictor analysis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be healthcare costs and psychological distress.<br /><br>Healthcare costs will be assessed with the Medical Consumption Questionnaire<br /><br>(MCQ) and the EuroQol-5D (EQ-5D). Psychological distress will be assessed with<br /><br>the Fear of Cancer Recurrence Inventory (FCRI).<br /><br><br /><br>Other study parameters:<br /><br>Baseline level of fear of recurrence severity, psychological distress, level of<br /><br>functioning impairment, and coping strategies will be assessed with the Fear of<br /><br>Cancer Recurrence Inventory (FCRI).<br /><br>Psychosocial problems and risk factors will be assessed with the Psychosocial<br /><br>Distress Questionnaire-Breast Cancer (PDQ-BC). The PDQ-BC consists of nine<br /><br>subscales: trait anxiety, social support, state anxiety, depressive symptoms,<br /><br>social problems, physical problems, body image, financial problems, and sexual<br /><br>problems.<br /><br>Self-efficacy will be assessed with an assembled questionnaire. </p><br>