Improving the efficiency and quality of follow-up after curative treatment for breast cancer.
|- candidate number||1195|
|- NTR Number||NTR121|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||14-aug-2005|
|- Secondary IDs||2 |
|- Public Title||Improving the efficiency and quality of follow-up after curative treatment for breast cancer.
|- Scientific Title||Improving the efficiency and quality of follow-up after curative treatment for breast cancer.
|- ACRONYM||MaZorg studie / MaCare trial|
|- 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 < 5 points)|
2. An informative/educational group intervention (Info-Care-Programme) in the first 3 months of follow-up improves the QoL in breast cancer patients treated with curative intent. (change in QoL > 10 points)
|- Healt Condition(s) or Problem(s) studied||Breast cancer|
|- 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||Not fulfilling the inclusion criteria.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jun-2005|
|- planned closingdate||1-jan-2008|
|- Target number of participants||320|
|- 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 3 months during the first year, every 6 months during the second year, and thereafter once a year until at least 5 years.
Mammography will be taken once a year, if needed supplemented by a breast ultrasound.
In arms 2 and 4, where the effect of "telephone follow-up" is studied, follow-up will consist of a first follow-up visit 2-6 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 3, 6, 9, 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 3 and 4, with an additional group intervention, the patients and their partners will follow the Info-Care Programme (ICP) led by 2 NPs, within 3 months the end of the treatment. This programme, given at a central location in the region, consists of 2 interactive group sessions of about 2-3 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).
|- Primary outcome||Cancer-specific QoL at 12 months after randomisation, measured by the global health status/QoL scale of the EORTC QLQ-C30. |
|- Secondary outcome||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.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. L.J. Boersma|
|- CONTACT for SCIENTIFIC QUERIES||Dr. L.J. Boersma|
|- Sponsor/Initiator ||Maastro Clinic, Department Radiotherapy|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||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.|
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.
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.
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.
5. Kimman MLš, 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.
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.
|- Brief summary||AIM:|
To investigate the cost-effectiveness (C-E) of different follow-up (f-up) strategies in curatively treated breast cancer patients (BCPs).
RESEARCH QUESTIONS in this patient group:
1) Can regular physical f-up partly be replaced by nurse-led telephone f-up (T-f-up), with similar quality of life (QoL)?
2) Does an informative/ educational group intervention (Info-Care-Programme (ICP)) improve QoL?
3) Which f-up strategy is the most cost-effective?
A randomised multicentre trial, with a 2x2 factorial design, 4 arms:
1) f-up as usual;
2) f-up once a year in combination with T-f-up;
3) arm 1 combined with an ICP;
4) arm 2 combined with an ICP.
BCPs treated with curative intent.
The ICP consists of 2 sessions in the first 3 months after treatment, and is led by two nurse-practitioners (NPs). At this ICP, BCPs and their partners will be informed about the psychosocial and physical consequences of the disease and its treatment, and where to present any problems. This is aimed at stimulating the perceived behavioural control (PBC), thereby improving QoL.
Partly replacing the physical f-up by T-f-up is expected to reduce health care costs.
Cancer-specific QoL (primary endpoint), QoL, anxiety, PBC, patients' satisfaction, costs, determined at randomisation, 3, 6, 12, and 18 months after inclusion.
320 BCPs will be included, to show with a power of 0.8 and a significance level of 0.05, that the cancer-specific (CS) QoL of T-f-up, measured at 12 months, is not more than 5 points less than after usual f-up. This will also allow detection of a difference of 10 points in CS QoL at 12 months between BCPs treated with or without the ICP, with a power of 0.95 and a significance level smaller than 0.01.
ECONOMIC EVALUATION will be performed from a societal perspective. Costs will consist of health care costs and costs outside health care. The incremental C-E ratios will be expressed as costs per quality adjusted life expectancy. The time perspective of the C-E analysis will be 5 years. Sensitivity analyses will be performed. Costs and effects occurring after 1 year will be discounted. Bootstrap analyses will be performed in order to quantify the uncertainty surrounding the C-E data.
month 1: training of NPs, months 1-19: inclusion of patients; months 19-31: f-up; months 31-36: data-analysis.
|- Main changes (audit trail)|
|- RECORD||11-aug-2005 - 5-aug-2012|
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