Breast Cancer Clinical Trial
— NABOROfficial title:
Effectiveness of persoNalized Care After Treatment for Nonmetastasized Breast Cancer Based On Risk of Recurrence, Personal Needs and Risk on (Late) Health Effects: the NABOR Study
Verified date | August 2023 |
Source | Comprehensive Cancer Centre The Netherlands |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Surveillance and aftercare for curatively treated primary breast cancer patients is currently mostly 'one-size-fits-all', but can be personalized based on patients' risk of recurrence (depending on patient-, tumor- and treatment-related characteristics) and their personal needs and preferences. The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) based on individual risks and needs might reduce unnecessary burden to the patient, increase quality of life and lower the costs of follow-up. The NABOR study will examine the effectiveness of personalized follow-up care, consisting of personalized surveillance (PSP) and personalized aftercare plans (PAP) incorporating individual recurrence risks and personal needs of breast cancer patients. The main question it aims to answer is: 'what is the effectiveness of personalized surveillance (PSP) and aftercare plans (PAP), compared to current follow-up care, on cancer worry and self-rated overall quality of life (EQ-VAS)'. Also the effect of PSP and PAP on health-related quality of life (EQ-5D), societal participation, risk perception, patient satisfaction, patients' need for support, shared decision-making, health care costs and resource use, cost-effectiveness, and number and severity of the detected recurrences will be investigated. Next, the uptake and appreciation of the personalized plans and related factors (patient, caregiver, hospital and societal/financial) will be evaluated. Patients participating in the study will have to fill in several questionnaires and give consent for requesting data from the Netherlands Cancer Registry and from their electronic health records (EHR). The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) will be implemented stepwise over a period of nine months in ten participating hospitals. To collect observations of both pre- and post-transition to PSP and PAP, each hospital will include patients during the nine months before and after its transition to personalized care. In the future, the results of this project, i.e. the developed tools, can also be used for personalization of survivorship care for other cancer survivors. More broadly, all findings will be actively shared with interested healthcare professionals and other interested parties in the Netherlands.
Status | Enrolling by invitation |
Enrollment | 1040 |
Est. completion date | March 6, 2027 |
Est. primary completion date | March 6, 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - female, - aged 40 years or older (because of higher risk on recurrence), - facing the decision for the organization of post-treatment surveillance and aftercare, - being curatively treated including breast surgery, for invasive non-metastasized breast cancer - able to understand the Dutch language in speech and writing. Exclusion Criteria: - bilateral breast cancers, - BRCA1/2 or CHEK2 carriers, - having an indication for MRI - participation in another study that requires fixed scheduled follow-up consultations and/or imaging. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Noordwest Ziekenhuisgroep | Alkmaar | Noord-Holland |
Netherlands | Gelre Ziekenhuizen | Apeldoorn | Gelderland |
Netherlands | Rijnstate | Arnhem | Gelderland |
Netherlands | Jeroen Bosch Ziekenhuis | Den Bosch | Brabant |
Netherlands | Haaglanden Medisch Centrum | Den Haag | Zuid-Holland |
Netherlands | Albert Schweitzer Ziekenhuis | Dordrecht | Zuid-Holland |
Netherlands | Ziekenhuisgroep Twente | Hengelo | Overijssel |
Netherlands | Alrijne Ziekenhuis | Leiderdorp | Zuid-Holland |
Netherlands | Bernhoven Ziekenhuis | Uden | Brabant |
Netherlands | Isala Klinieken | Zwolle | Overijssel |
Lead Sponsor | Collaborator |
---|---|
Comprehensive Cancer Centre The Netherlands | Borstkanker Onderzoek Groep, Dutch Breast Cancer Association, Netherlands Institute for Health Services Research, University of Twente |
Netherlands,
Luigjes-Huizer YL, van der Lee ML, Richel C, Masselink RA, de Wit NJ, Helsper CW. Patient-reported needs for coping with worry or fear about cancer recurrence and the extent to which they are being met: a survey study. J Cancer Surviv. 2022 Dec 30:1-9. doi: 10.1007/s11764-022-01326-5. Online ahead of print. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health literacy | Set of Brief Screening Questions (SBSQ); An average score of =2 indicates inadequate health literacy, and a score >2 indicates adequate health literacy | 1 timepoint within 2 years: at T1 (1 year after end of treatment) | |
Other | Mental adjustment to cancer | Mental Adjustment to Cancer scale (MAC); higher scores represent greater severity of the behaviors in the patient's struggle with cancer | 1 timepoint within 2 years: at T1 (1 year after end of treatment) | |
Other | Clinical characteristics, obtained from patients' Electronic Health Records | Performance of imaging (i.e. conclusion of imaging, breast density) and pathology (i.e. type of biopsies, cytology, histology), detected recurrences | up to 2 years | |
Other | Provided aftercare and surveillance; obtained from patients' Electronic Health Records | Information on frequency and reason of breast cancer-related hospital visits. This also includes (if applicable): information on decisions made about aftercare and surveillance, whether prediciton models or decision aids are used and whether aftercare and survaillance plans are personalized. | up to 2 years | |
Other | Tumor and treatment characteristics obtained from the Netherlands Cancer Registry | Tumour- and treatment-related characteristics, like tumour and nodal stage, differentiation grade, receptor status, radiotherapy, systemic therapy, targeted therapy, possible recurrences. | up to 2 years | |
Primary | Change in cancer worry | Cancer Worry Scale (CWS); Range 6-24, higher scores indicate greater worrying | 3 timepoints within 2 years: at T1 (1 year after end of treatment), T3 (2 years after end of treatment) and T5 (3 years after end of treatment) | |
Primary | Change in overall quality of life | EQ-VAS (visual analogue scale of the EQ-5D); Range 0-100, higher scores indicate greater health-related quality of life | 3 timepoints within 2 years: at T1 (1 year after end of treatment), T3 (2 years after end of treatment) and T5 (3 years after end of treatment) | |
Secondary | Change in health-related quality of life on five domains | Quality of life questionnaire (EQ-5D-5L); higher score indicate better quality of life | 3 timepoints within 2 years: at T1 (1 year after end of treatment), T3 (2 years after end of treatment) and T5 (3 years after end of treatment) | |
Secondary | Change in health-related quality of life, concerning mental and physical domains | Short-Form health index (SF-12); higher scores indicate greater quality of life | 3 timepoints within 2 years: at T1 (1 year after end of treatment), T3 (2 years after end of treatment) and T5 (3 years after end of treatment) | |
Secondary | Change in health-related quality of life, concerning physical symptoms | European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC-QLQ-C30); higher scores indicate better health-related quality of life | 3 timepoints within 2 years: at T1 (1 year after end of treatment), T3 (2 years after end of treatment) and T5 (3 years after end of treatment) | |
Secondary | Work productivity | iMTA Productivity Cost Questionnaire (iPCQ); measures absence from work, reduced productivity while at work and productivity losses related to unpaid work | 5 timepoints within 2 years: at T1 (1 year after end of treatment), T2 (1,5 years after end of treatment), T3 (2 years after end of treatment), T4 (2,5 years after end of treatment) and T5 (3 years after end of treatment) | |
Secondary | Healthcare consumption | iMTA Medical Consumption Questionnaire (iMCQ); measures frequency of visits to health care practitioners outside the hospital and the extent to which others needed to join the patient in going to these visits, and the use of home care and medication | 5 timepoints within 2 years: at T1 (1 year after end of treatment), T2 (1,5 years after end of treatment), T3 (2 years after end of treatment), T4 (2,5 years after end of treatment) and T5 (3 years after end of treatment) | |
Secondary | Risk perception | Self-composed questionnaire on perceived risk of recurrence, measuring perceived absolute and comparative risk, perceived comparative risk and perceived course of the risk over time | 3 timepoints within 2 years: at T1 (1 year after end of treatment), T3 (2 years after end of treatment) and T5 (3 years after end of treatment) | |
Secondary | Shared decision-making | Shared Decision-Making Questionnaire (SDM-Q-9); range 0-45, higher scores indicate a greater level of perceived involvement in decision-making | 1 timepoint within 2 years: at T1 (1 year after end of treatment) | |
Secondary | Patients' role in decision-making | Control Preference Scale (CPS); assesses the patient's preferred and perceived degree of control when decisions about treatment are being made. Higher scores indicate a preference for higher level of control in decision making | 1 timepoint within 2 years: at T1 (1 year after end of treatment) | |
Secondary | Patient satisfaction | Consumer Quality breast care (CQ-breast index); higher scores indicate a greater satisfaction | 3 timepoints within 2 years: at T1 (1 year after end of treatment), T3 (2 years after end of treatment) and T5 (3 years after end of treatment) | |
Secondary | Societal participation | Lubben Social Network Scale (LSNS); higher scores indicate greater social engagement | 3 timepoints within 2 years: at T1 (1 year after end of treatment), T3 (2 years after end of treatment) and T5 (3 years after end of treatment) | |
Secondary | Need for support for fear of cancer recurrence | Questionnaire as composed by Luigjes-Huizer and colleagues, assesses the need for and experiences with support for fear of cancer recurrence | 3 timepoints within 2 years: at T1 (1 year after end of treatment), T3 (2 years after end of treatment) and T5 (3 years after end of treatment) |
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