Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR121; 2
Study information
Scientific title
Acronym
MaZorg studie/MaCare trial
Study hypothesis
1. Regular physical follow-up can partly be replaced by nurse-led telephone follow-up, with at least similar Quality of Life (QoL), in breast cancer patients treated with curative intent (change in QoL less than five points)
2. An informative/educational group intervention (Info-Care-Programme) in the first three months of follow-up improves the QoL in breast cancer patients treated with curative intent (change in QoL more than ten points)
Ethics approval
Received from the local medical ethics committee
Study design
Randomised, active controlled, factorial multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Breast cancer
Intervention
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 three months during the first year, every six months during the second year, and thereafter once a year until at least five years. A mammography will be taken once a year, if needed supplemented by a breast ultrasound.
In arms two and four, where the effect of 'telephone follow-up' is studied, follow-up will consist of a first follow-up visit two to six weeks after treatment as usual, to evaluate the acute treatment related side effects. Thereafter, patients will only once a year be seen by either the medical oncologist/surgeon/Nurse-Practitioner (NP) or the radiation oncologist. This visit will be combined with the annual mammography. At the regular follow-up times (i.e. at three, six, nine, and 18 months), the NP will have a telephone interview with the patients. This telephone interview will be done by open discussion, and a semi structured questionnaire, including screening for physical and psychosocial symptoms, and compliance to hormonal therapy (if applicable). In addition, data about the side effects of treatment are collected during this telephone interview.
In the arms three and four, with an additional group intervention, the patients and their partners will follow the Info-Care Programme (ICP) led by two NPs, within three months of the end of the treatment. This programme, given at a central location in the region, consists of two interactive group sessions of about two to three hours of psycho-education, including mutual contact between participants for sharing. The ICP intervention is aimed at improving perceived behavioural control, and reduction of anxiety. To improve the feeling of self control and self reliance, information will be given about being alert to physical and psychosocial symptoms related to breast cancer and the (side) effects of the treatment. Information is given about the actions (e.g. call for professional help) that may be undertaken when symptoms occur, and about the scale of health care workers and interventions that are available. Discussions will also be conducted addressing issues such as how to deal with anxiety, mood changes, and changes in intimacy (i.e. altered feminity, body image, sexuality).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Cancer-specific QoL at 12 months after randomisation, measured by the global health status/QoL scale of the EORTC QLQ-C30.
Secondary outcome measures
1. Other QoL scales, including breast cancer specific items, EuroQoL, perceived behavioural control, anxiety, and patients' satisfaction with follow-up
2. Costs will be determined based on standardised cost-diaries filled out by the patients over a predefined period, at the same time points.
3. The incidence of local recurrences and distant metastases, by whom these recurrences are detected, and whether they are detected with or without symptoms
Overall trial start date
01/06/2005
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
320
Participant exclusion criteria
Does not comply with the above inclusion criteria
Recruitment start date
01/06/2005
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
MAASTRO Clinic
Maastricht
6202 AZ
Netherlands
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/17199887
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19200391
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20429948
4. 2011 economic evaluation results in http://www.ncbi.nlm.nih.gov/pubmed/21257305
Publication citations
-
Study protocol
Kimman ML, Voogd AC, Dirksen CD, Falger P, Hupperets P, Keymeulen K, Hebly M, Dehing C, Lambin P, 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, 2007, 7, 1, doi: 10.1186/1471-2407-7-1.
-
Results
Kimman ML, Dirksen CD, Lambin P, Boersma LJ, Responsiveness of the EQ-5D in breast cancer patients in their first year after treatment., Health Qual Life Outcomes, 2009, 7, 11, doi: 10.1186/1477-7525-7-11.
-
Results
Kimman ML, Bloebaum MM, Dirksen CD, Houben RM, Lambin P, Boersma LJ, Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer., BMC Cancer, 2010, 10, 174, doi: 10.1186/1471-2407-10-174.
-
Economic evaluation results
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, Economic evaluation of four follow-up strategies after curative treatment for breast cancer: results of an RCT., Eur. J. Cancer, 2011, 47, 8, 1175-1185, doi: 10.1016/j.ejca.2010.12.017.