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

Completed
Conditions
Breast cancer patients treated with curative intent
Registration Number
NL-OMON26348
Lead Sponsor
Prof.dr. Ph. Lambin, MAASTRO clinic, Dr. Tanslaan 12, 6229 ET Maastricht
Brief Summary

1. Kimman ML, Voogd AC, Dirksen CD, Falger P, Hupperets P, Keymeulen K, Hebly M, Dehing C, Lambin Ph, Boersma LJ. Follow-up after curative treatment for breast cancer: why do we still adhere to frequent outpatient clinic visits? Eur J Cancer 43: 647-653, 2007.<br> 2. Kimman ML, Voogd AC, Dirksen CD, Falger P, Hupperets P, Keymeulen K, Hebly M, Dehing C, Lambin Ph, Boersma LJ. Improving the quality and efficiency of follow-up after curative treatment for breast cancer - rationale and study design of the MaCare trial. BMC Cancer 7:1, 2007.<br> 3. Kimman ML, Dirksen CD, Lambin Ph, Boersma LJ. Responsiveness of the EQ-5D compared to the EORTC QLQ-C30 in primary breast cancer patients after treatment. BMC Health and Quality of Life Outcomes 7:11, 2009.<br> 4. Kimman ML Bloebaum MMF, Dirksen CD, Houben RMA, Lambin P, Boersma LJ Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer. BMC Cancer 30;10:174, 2010.<br> 5. Kimman ML¹, Dirksen CD, Voogd AC, Falger P, Gijsen BCM, Thuring M, Lenssen A, van der Ent F, Verkeyn J, Haekens C, Hupperets P, Nuytinck JKS, van Riet Y, Brenninkmeijer SJ, Scheijmans L, Kessels A, Lambin Ph, Boersma LJ Nurse-led telephone follow-up and an educational group programme after breast cancer treatment: results of a 2x2 randomised controlled trial. Eur J Cancer, 47(7):1027-36, 2011.<br> 6. Kimman ML, Dirksen CD, Voogd AC Falger P, Gijsen BC, Thuring M, Lenssen A, van der Ent F, Verkeyn J, Haekens C, Hupperets P, Nuytinck JK, van Riet Y, Brenninkmeijer SJ, Scheijmans LJ, Kessels A, Lambin P, Boersma LJ.An economic evaluation of four follow-up strategies after curative treatment for breast cancer: results of an RCT. Eur J Cancer 47(8):1175-85, 2011.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
320
Inclusion Criteria

1. Female patients with breast cancer without distant metastases;

2. WHO performance scale 0-2;

Exclusion Criteria

Not fulfilling the inclusion criteria.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cancer-specific QoL at 12 months after randomisation, measured by the global health status/QoL scale of the EORTC QLQ-C30.
Secondary Outcome Measures
NameTimeMethod
The other QoL scales, including breast cancer specific items, EuroQoL, perceived behavioural control, anxiety, and patients' satisfaction with follow-up.<br /> 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.<br /> 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.
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