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Improving the efficiency and quality of follow-up after curative treatment for breast cancer.

Improving the efficiency and quality of follow-up after curative treatment for breast cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26348
Enrollment
320
Registered
2005-08-14
Start date
2005-06-01
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

Breast cancer patients treated with curative intent

Interventions

The first arm is the standard arm, and consists of usual follow-up as described in the regional guidelines. The patient has an appointment with the medical specialist and/or nurse-practitioner every

Sponsors

Prof.dr. Ph. Lambin, MAASTRO clinic, Dr. Tanslaan 12, 6229 ET Maastricht
Lead Sponsor

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

MeasureTime frame
Cancer-specific QoL at 12 months after randomisation, measured by the global health status/QoL scale of the EORTC QLQ-C30.

Secondary

MeasureTime 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

Public ContactL.J. Boersma

MAASTRO Clinic P.O. Box 5800

+31 (0)88 4455666

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)