Improving the efficiency and quality of follow-up after curative treatment for breast cancer
Completed
- Conditions
- Breast cancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN74071417
- Lead Sponsor
- Maastro Clinic (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 320
Inclusion Criteria
1. Female patients with breast cancer without distant metastases
2. World Health Organisation (WHO) performance scale zero to two
3. No concomitant/previous malignant disease or psychiatric disorders
4. Treated with curative intent (i.e. lumpectomy or mastectomy, with or without radiotherapy and/or chemotherapy)
5. Treatment completed less than eight weeks prior to randomisation
6. Not included in another trial, requiring frequent follow-up
7. Able to read and speak fluently in Dutch
8. No medical diseases (treatment-related side-effects, concomitant tumours) requiring frequent follow-up
Exclusion Criteria
Does not comply with the above inclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cancer-specific QoL at 12 months after randomisation, measured by the global health status/QoL scale of the EORTC QLQ-C30.
- Secondary Outcome Measures
Name Time Method 1. Other QoL scales, including breast cancer specific items, EuroQoL, perceived behavioural control, anxiety, and patients' satisfaction with follow-up<br>2. Costs will be determined based on standardised cost-diaries filled out by the patients over a predefined period, at the same time points. <br>3. The incidence of local recurrences and distant metastases, by whom these recurrences are detected, and whether they are detected with or without symptoms