Patient-partnered Research in Investigating Fear of Cancer Recurrence in Kidney Cancer

Официальное название

Patient-partnered Research: a Key to Investigating Fear of Cancer Recurrence in Patients With Surgically Treated Kidney Cancer (PP-RECURK)

Обзор

The goal of this observational study is to gather real-world information about Fear of Cancer Recurrence (FCR) following surgery in patients with renal cell carcinoma (RCC) and their partners/spouses by 1) establishing a panel consisting of patients with or without partners/spouses to facilitate patient-partnered research. Furthermore, 2) Through discussions among panel members and researchers identification of the most pertinent topics related to FCR, as well as the optimal timing and methods for collecting that information in the follow-up care after surgery. Finally, to conduct a feasibility and pilot study to investigate the feasibility of the recommendations developed in 1) + 2) and assess FCR in patients with RCC following surgery and their partners/spouses. 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.

Подробное описание

Rationale Previously, Fear of Cancer Recurrence (FCR) has been investigated in patients with renal cell carcinoma (RCC) showing that FCR is the most common source of frustration, and the prevalence of FCR has been estimated to be 54% in patients with localized RCC.

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.

Вмешательства

• Другое 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).
• Другое 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.

Первичные конечные точки

• Phase 1: Assessment of the recruitment to and composition the patient-partner panel [Срок оценки: From inclusion to week 16 or date of last subject included whichever comes first.]
• Phase 1: Assessment of the degree of patient and partner/spouse involvement [Срок оценки: From inclusion to week 26 or end of engagement whichever comes first.]
• Phase 2: To investigate whether the recommendations for timing, instructions, mode of administration and Fear of Cancer Recurrence questions stated in phase 1 are feasible in a clinical setting, [Срок оценки: From inclusion to week 52.]
• Phase 2: The prevalence of Fear of Cancer Recurrence in single patients with localized Renal Cell Carcinoma [Срок оценки: From inclusion to week 52 or when the subject withdraws from the study whichever comes first.]
• Phase 2: The prevalence of Fear of Cancer Recurrence in patients with localized Renal Cell Carcinoma and living in a relationship with a partner/spouse. [Срок оценки: From inclusion to week 52 or when the subject withdraws from the study whichever comes first.]
• Phase 2: The prevalence of Fear of Cancer Recurrence in partners/spouses to patients with localized Renal Cell Carcinoma. [Срок оценки: From inclusion to week 52 or when the subject withdraws from the study whichever comes first.]

Вторичные конечные точки (12)

• Phase 2: Associations between data on Fear of Cancer Recurrence and disease stage in single patients. [Срок оценки: From inclusion to week 52.]
• Phase 2: Associations between data on Fear of Cancer Recurrence and comorbidity burden in single patients. [Срок оценки: From inclusion to the study to week 52 or when the subject withdraws consent whichever comes first.]
• Phase 2: Associations between data on Fear of Cancer Recurrence and sex in single patients. [Срок оценки: From inclusion to week 52.]
• Phase 2: Associations between data on Fear of Cancer Recurrence and age in single patients. [Срок оценки: From inclusion to week 52.]
• Phase 2: Associations between data on Fear of Cancer Recurrence and educational level in single patients. [Срок оценки: From inclusion to week 52.]
• Phase 2: Associations between data on Fear of Cancer Recurrence and disease stage in patients with a partner/spouse. [Срок оценки: From inclusion to week 52.]
• Phase 2: Associations between data on Fear of Cancer Recurrence and comorbidity burden in patients with a partner/spouse. [Срок оценки: From inclusion to week 52.]
• Phase 2: Associations between data on Fear of Cancer Recurrence and sex in patients with a partner/spouse. [Срок оценки: From inclusion to week 52.]
• Phase 2: Associations between data on Fear of Cancer Recurrence and age in patients with a partner/spouse. [Срок оценки: From inclusion to week 52.]
• Phase 2: Associations between data on Fear of Cancer Recurrence and educational level in patients with partner/spouse. [Срок оценки: From inclusion to week 52.]
• Phase 2: Associations between data on Fear of Cancer Recurrence and patients' disease stage in partners/spouses of non-single patients. [Срок оценки: From inclusion to week 52.]
• Phase 2: Associations between data on Fear of Cancer Recurrence and partners'/spouses' comorbidities in partners/spouses of non-single patients. [Срок оценки: From inclusion to week 52.]

Критерии участия

Критерии включения

Phase 1:

• Single patients diagnosed with Renal Cell Carcinoma (RCC) or patients with RCC being in an intimate relationship with a partner/spouse
• Partner/spouse to patients who fullfil the inclusion criteria
• 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
• Partner/spouse to patients who fullfill the inclusion criteria
• 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

Критерии исключения

Both phases, both patients and partners/spouses:

• Diagnosed with cognitive impairment
• Untreated psychiatric disorders due to non-compliance

Phase 2:

• Patients and partners/spouses who were panelists in phase 1

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Дания · 3 центра

• Aalborg University Hospital — Aalborg
• Aarhus University Hospital — Aarhus
• Gødstrup Hospital — Herning

Публикации

• 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. PMID 33729634
• 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. PMID 10474547
• 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. PMID 27001093
• Altman M, Huang TTK, Breland JY. Design Thinking in Health Care. Prev Chronic Dis. 2018 Sep 27;15:E117. doi: 10.5888/pcd15.180128. PMID 30264690
• 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. PMID 18414902
• 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. PMID 34762248
• 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. PMID 32955409

Идентификаторы

NCT: NCT07234656 · 1-16-02-314-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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