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The BREATH study: Online self-management to facilitate adjustment after curative breast cancer.

Recruiting
Conditions
breast cancer, mamma carcinoma, borstkanker, Internet, web-based intervention, self-management
Registration Number
NL-OMON28971
Lead Sponsor
Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
170
Inclusion Criteria

1. Histologically proven malignancy of the breast;

2. Breast cancer is treated with curative intent surgery and adjuvant chemotherapy and/or radiotherapy;

Exclusion Criteria

1. Patients treated only with surgery;

2. Patients with metastatic breast carcinoma;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Psychological distress (SCL-90 ; Arrindell, 2003) and empowerment (Cancer Empowerment Questionnaire; Van den Berg, 2010).<br><br /><br /><br>1. Arrindell WA, Ettema JHM. SCL-90: Handleiding bij een multidimensionele psychopathologie-indicator [SCL-90: Manual for a multifaceted measure of psychopathology]. Lisse, Swets & Zeitlinger, 2003;<br /><br>2. Van den Berg SW, Gielissen M, Prins JP. Validation of an empowerment questionnaire in breast cancer survivors. Meeting abstract 12th World Congress of Psycho-Oncology, May 2010.
Secondary Outcome Measures
NameTimeMethod
1. Quality of life generally (EORTC QLQ C30) and specifically for breast cancer patients (BR23);<br /><br>2. Anxiety and depression (HADS);<br /><br>3. Remoralization (RS);<br /><br>4. Perceived control (Mastery-scale);<br /><br>5. Positive adjustment (PAQ);<br /><br>6. Personality (BFI);<br /><br>7. Coping (Cope);<br /><br>8. Impact of events (IES);<br /><br>9. Illness cognitions (ICQ);<br /><br>10. Fear of cancer recurrence (CWS);<br /><br>11. Openness to discuss cancer (ODHCF);<br /><br>12. Self-efficacly (SE-28);<br /><br>13. Fatigue (CIS-fatigue).<br><br /><br /><br>For patients in the experimental group, also medical disease-specific data are collected and technical data on the use of the web-based intervention, in addition to the standardized questionnaires.
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