Effectiveness of Personalized Surveillance and Aftercare for Breast Cancer

NCT05975437 | Enrolling By Invitation

• 1 other identifier: 10330032010001
• Study Type: observational
• Target: 1,040
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Breast Cancer; Breast Cancer Female; Survivorship

Keywords

breast cancer; aftercare; surveillance; personalization; cost-effectiveness

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (11)

• Change in health-related quality of life on five domains

  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)

• Change in health-related quality of life, concerning mental and physical domains

  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)

• Change in health-related quality of life, concerning physical symptoms

  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)

• Work productivity

  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)

• Healthcare consumption

  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)

Other Outcomes (5)

• Health literacy

  1 timepoint within 2 years: at T1 (1 year after end of treatment)

• Mental adjustment to cancer

  1 timepoint within 2 years: at T1 (1 year after end of treatment)

• Clinical characteristics, obtained from patients' Electronic Health Records

  up to 2 years

Study Arms (2)

Care as usual

Participants who are included during care as usual, before the hospital's transition to personalized follow-up. Care as usual is organized as 'one-size fits all' and does not take individual differences in prognoses and needs into account. For the majority of hospitals follow-up includes annual mammography and physical examination combined with discussing of the results of the mammogram and sometimes also the patient's needs.

Personalized care

Participants who are included after the hospital's transition to personalized follow-up. After this transition, personalized follow-up becomes the standard form of care for all patients, regardless of their participation in this study. Participants of this group receive personalized follow-up, which is based on individual prognoses and needs. Personalized follow-up will be provided by the use of personalized surveillance (PSP) and personalized aftercare plans (PAP).

Other: personalized surveillance plans (PSP) and personalized aftercare plans (PAP)

Interventions

personalized surveillance plans (PSP) and personalized aftercare plans (PAP) OTHER

The PSP contains decisions on the surveillance trajectory based on individual risks and needs, assessed with the 'Breast Cancer Surveillance Decision Aid' including the INFLUENCE prediction tool. The PAP contains decisions on the aftercare trajectory based on individual needs and preferences and available care resources, which decision-making is supported by a patient decision aid.

Personalized care

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All new female patients who were curatively treated for non-metastasized primary breast cancer and start follow-up care in the hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Comprehensive Cancer Centre The Netherlands: lead
• University of Twente: collaborator
• Dutch Breast Cancer Association: collaborator
• Borstkanker Onderzoek Groep: collaborator
• Netherlands Institute for Health Services Research: collaborator

Study Sites (10)

Gelre Ziekenhuizen

Apeldoorn, Gelderland, Netherlands

Location

Rijnstate

Arnhem, Gelderland, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, Netherlands

Location

Bernhoven Ziekenhuis

Uden, North Brabant, Netherlands

Location

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, Netherlands

Location

Ziekenhuisgroep Twente

Hengelo, Overijssel, Netherlands

Location

Isala Klinieken

Zwolle, Overijssel, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, Netherlands

Location

Alrijne Ziekenhuis

Leiderdorp, South Holland, Netherlands

Location

Haaglanden Medisch Centrum

The Hague, South Holland, Netherlands

Location

Related Publications (2)

• 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. 2024 Jun;18(3):791-799. doi: 10.1007/s11764-022-01326-5. Epub 2022 Dec 30.

  PMID: 36585574 BACKGROUND

• Klaassen-Dekker A, Drossaert CHC, Van Maaren MC, Van Leeuwen-Stok AE, Retel VP, Korevaar JC, Siesling S; NABOR project group. Personalized surveillance and aftercare for non-metastasized breast cancer: the NABOR study protocol of a multiple interrupted time series design. BMC Cancer. 2023 Nov 14;23(1):1112. doi: 10.1186/s12885-023-11504-y.

  PMID: 37964214 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sabine Siesling

  Comprehensive Cancer Center of The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, full professor

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: August 3, 2023
• Study Start: March 6, 2023
• Primary Completion (Estimated): March 6, 2027
• Study Completion (Estimated): March 6, 2027
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

NL (10)