Patient-partnered Research in Investigating Fear of Cancer Recurrence in Kidney Cancer
NCT ID: NCT07234656
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
105 participants
OBSERVATIONAL
2025-09-30
2027-01-31
Brief Summary
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In phase 1 participants (panel members) will be asked to collaborate with researchers in the development of recommendations for FCR questions, mode of administration and timing in the follow-up care after surgically treated kidney cancer.
In phase 2 participants (patients and partners) in follow-up care after surgically treated kidney cancer are asked to answer questions about FCR at specific timepoints defined by panel members and researchers in phase 1.
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Detailed Description
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Studies in families with cancer show that approximately 50% of family caregivers experience FCR.
Patient involvement in research is much requested, however, no study to date has involved patients and partners/spouses in the investigation of FCR in patients with kidney cancer and their family caregivers.
Therefore, in this study the investigators will ask patients with localized kidney cancer and their partners/spouses to contribute with their perspectives on what questions to ask in the follow-up care after surgery for kidney cancer to identify FCR. For this purpose, the validated 42-item Fear of Cancer Inventory (FCRI) will be used for inspiration. A caregiver version of the FCRI exists, but has not been translated to Danish and thus translation will be conducted in this study.
This study is expected to provide information to clinicians on how to comply with the European Association of Urology guideline that recommends psychological evaluation for all patients diagnosed with RCC and involvement of patients in adjuvant RCC treatment decisions. Furthermore, the investigators conduct this study to give patients with kidney cancer and partners/spouses a voice in the investigation of FCR in the clinical follow-up care after surgery. This provides an opportunity for a collaboration between patients, partners, patients associations and professional researchers to identify the most appropriate FCR questions, timing, and mode of administration to optimize patient adherence/compliance and treatment outcomes.
Method The project has two phases. Phase 1: Establishment of a patient/partner panel who in collaboration with researchers will use the 5-stage Design thinking model to develop recommendations for investigating FCR in patients and their partners/spouses in follow-up care after surgically treated kidney cancer.
The Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework described by Glasgow et al. will be applied for the process evaluation of recruitment and eligibility of panelists.
The level of meaningful patient/partner/spouse engagement in the project will be evaluated using the Patient Engagement in Research Scale (PEIRS-22).
Phase 2:
The recommendations produced in phase 1 will be tested in a pilot and feasibility study along with investigation of additional factors possibly affecting fear of cancer recurrence in patients and their partners/spouses. All evaluations will be done statistically.
Perspectives If the phase 2 pilot-study turns out successfully in defining FCR in patients with RCC and their partners/spouses, the researchers will seek to perform a national follow-up study, that can constitute a foundation for implementation of FCR as part of standard clinical practice, e.g. detecting when FCR reaches a level that needs interference such as psychological counselling etc.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Panel members
6 patients with spouses/partners and 3 single patients. In total 15 subjects.
Phase 1: Establishment of a patient-partner panel
Phase 1: Establishment of a patient-partner panel who in collaboration with researchers define Fear of Cancer Recurrence questions, mode of administration and timing for investigating Fear of Cancer Recurrence in phase 2 (pilot testing in a feasibility study).
Pilot population
In total 90 subjects (patients with or without partners)
Phase 2: Feasibility testing of FCR questions, mode of administration and timing for investigating Fear of Cancer Recurrence
As the intervention for phase 2 is a product of the collaboration and discussions between panel members and researchers during phase 1, the intervention can not be described more detailed.
Interventions
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Phase 1: Establishment of a patient-partner panel
Phase 1: Establishment of a patient-partner panel who in collaboration with researchers define Fear of Cancer Recurrence questions, mode of administration and timing for investigating Fear of Cancer Recurrence in phase 2 (pilot testing in a feasibility study).
Phase 2: Feasibility testing of FCR questions, mode of administration and timing for investigating Fear of Cancer Recurrence
As the intervention for phase 2 is a product of the collaboration and discussions between panel members and researchers during phase 1, the intervention can not be described more detailed.
Eligibility Criteria
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Inclusion Criteria
* Single patients diagnosed with Renal Cell Carcinoma (RCC) or patients with RCC being in an intimate relationship with a partner/spouse
* Patients have undergone surgery due to localized RCC (T1-T2-T3 tumor)
* Time since surgery: 0-120 months
* Danish speaking patients and partners/spouses. Must be able to speak, write and read Danish
* Patients/partners/spouses able to and willing to attend online project meetings or in person at Gødstrup Hospital.
Phase 2:
* Single patients diagnosed with Renal Cell Carcinoma (RCC) or patients with RCC being in an intimate relationship with a partner/spouse
* Patients who have undergone surgery due to localized RCC (T1-T2-T3 tumor)
* Danish speaking patients and partners/spouses. Must be able to speak, write and read Danish
* Able to receive digital communication from the hospital
* Informed consent must be signed before answering Fear of Cancer Recurrence questions
Exclusion Criteria
* Diagnosed with cognitive impairment
* Untreated psychiatric disorders due to non-compliance
Phase 2:
• Patients and partners/spouses who were panelists in phase 1
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Brigitta Rasmussen Villumsen
OTHER
Responsible Party
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Brigitta Rasmussen Villumsen
Principal Investigator
Principal Investigators
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Brigitta R Villumsen, PhD
Role: STUDY_CHAIR
Gødstrup Hospital
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Gødstrup Hospital
Herning, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Mette S Olesen, MSN
Role: primary
Brigitta R Villumsen, PhD
Role: backup
References
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Hamilton CB, Hoens AM, McKinnon AM, McQuitty S, English K, Hawke LD, Li LC. Shortening and validation of the Patient Engagement In Research Scale (PEIRS) for measuring meaningful patient and family caregiver engagement. Health Expect. 2021 Jun;24(3):863-879. doi: 10.1111/hex.13227. Epub 2021 Mar 17.
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
Roberts JP, Fisher TR, Trowbridge MJ, Bent C. A design thinking framework for healthcare management and innovation. Healthc (Amst). 2016 Mar;4(1):11-4. doi: 10.1016/j.hjdsi.2015.12.002. Epub 2016 Jan 14.
Altman M, Huang TTK, Breland JY. Design Thinking in Health Care. Prev Chronic Dis. 2018 Sep 27;15:E117. doi: 10.5888/pcd15.180128.
Simard S, Savard J. Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence. Support Care Cancer. 2009 Mar;17(3):241-51. doi: 10.1007/s00520-008-0444-y. Epub 2008 Apr 15.
Smith A', Wu VS, Lambert S, Lamarche J, Lebel S, Leske S, Girgis A. A systematic mixed studies review of fear of cancer recurrence in families and caregivers of adults diagnosed with cancer. J Cancer Surviv. 2022 Dec;16(6):1184-1219. doi: 10.1007/s11764-021-01109-4. Epub 2021 Nov 11.
Bergerot CD, Battle D, Philip EJ, Bergerot PG, Msaouel P, Smith A', Bamgboje AE, Shuch B, Derweesh IH, Jonasch E, Stern AP, Pal SK, Staehler M. Fear of Cancer Recurrence in Patients With Localized Renal Cell Carcinoma. JCO Oncol Pract. 2020 Nov;16(11):e1264-e1271. doi: 10.1200/OP.20.00105. Epub 2020 Sep 18.
Other Identifiers
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1-16-02-314-25
Identifier Type: -
Identifier Source: org_study_id
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