Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
27/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr L J Boersma

ORCID ID

Contact details

MAASTRO Clinic
Postbus 5800
Maastricht
6202 AZ
Netherlands

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 measures

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

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

Sponsor information

Organisation

Maastro Clinic (Netherlands)

Sponsor details

Department Radiotherapy
dr. Tanslaan 12
Maastricht
6229 ET
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes