Improving the efficiency and quality of follow-up after curative treatment for breast cancer
| ISRCTN | ISRCTN74071417 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74071417 |
| Secondary identifying numbers | NTR121; 2 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 27/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr L J Boersma
Scientific
Scientific
MAASTRO Clinic
Postbus 5800
Maastricht
6202 AZ
Netherlands
Study information
| Study design | Randomised, active controlled, factorial multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | MaZorg studie/MaCare trial |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2005 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 320 |
| Key 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 |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
MAASTRO Clinic
Maastricht
6202 AZ
Netherlands
6202 AZ
Netherlands
Sponsor information
Maastro Clinic (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department Radiotherapy
dr. Tanslaan 12
Maastricht
6229 ET
Netherlands
"ROR" |
https://ror.org/059wkzj26 |
|---|
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | study protocol | 02/01/2007 | Yes | No | |
| Results article | results | 07/02/2009 | Yes | No | |
| Results article | results | 30/04/2010 | Yes | No | |
| Results article | economic evaluation results | 01/05/2011 | Yes | No |
