Breast cancer patients treated with curative intent
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients with breast cancer without distant metastases; 2. WHO performance scale 0-2; 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 < 8 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
Exclusion criteria: Not fulfilling the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cancer-specific QoL at 12 months after randomisation, measured by the global health status/QoL scale of the EORTC QLQ-C30. | — |
Secondary
| Measure | Time frame |
|---|---|
| The other QoL scales, including breast cancer specific items, EuroQoL, perceived behavioural control, anxiety, and patients' satisfaction with follow-up. In addition, costs will be determined based on standardized cost-diaries filled out by the patients over a predefined period, at the same time points. Finally, we will register the incidence of local recurrences and distant metastases, by whom these recurrences are detected, and whether they are detected with or without symptoms. | — |
Contacts
MAASTRO Clinic P.O. Box 5800