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

NCT07234656 | Recruiting

• 1 other identifier: 1-16-02-314-25
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Fear of Cancer Recurrence; Renal Cell Carcinoma (Kidney Cancer)

Keywords

Fear of Cancer Recurrence; Patient involvement in research; Kidney cancer

Outcome Measures

Primary Outcomes (6)

• Phase 1: Assessment of the recruitment to and composition the patient-partner panel

  The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework will be applied for the assessment of the recruitmentprocess, eligibility of panelists and their representativity.

  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

  The Patient Engagement in Research Scale (PEIRS) will be applied to assess the degree of meaningful patient and family caregiver engagement in research from a patient and partner/spouse perspective. The 22-item Patient Engagement in Research Scale (PEIRS) score ranges from 0-88. Minimum value per item: 0 (Strongly Disagree), maximum value per item: 4 (Strongly Agree). Higher scores = better engagement in research. To make interpretation easier, many studies convert the raw total to a 0-100 score calculated by taking the total sum score, divided by 88 (22 items X 4 scores), and multiplying it by 100

  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,

  Patients' and partners/spouses' compliance to the investigation of Fear of Cancer Recurrence will be evaluated using descriptive statistics. Fulfillment of the feasibility criteria are met when 80% of the included subjects complete the pilot testing.

  From inclusion to week 52.

• Phase 2: The prevalence of Fear of Cancer Recurrence in single patients with localized Renal Cell Carcinoma

  Descriptive statistics will be used to present the level of Fear of Cancer Recurrence. Data will be presented as median Fear of Cancer Recurrence score with 95% Confidence Interval.

  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.

  Descriptive statistics will be used to present the level of Fear of Cancer Recurrence. Data will be presented as median Fear of Cancer Recurrence score with 95% Confidence Interval.

  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.

  Descriptive statistics will be used to present the level of Fear of Cancer Recurrence. Data will be presented as median Fear of Cancer Recurrence score with 95% Confidence Interval.

  From inclusion to week 52 or when the subject withdraws from the study whichever comes first.

Secondary Outcomes (15)

• Phase 2: Associations between data on Fear of Cancer Recurrence and disease stage in single patients.

  From inclusion to week 52.

• Phase 2: Associations between data on Fear of Cancer Recurrence and comorbidity burden in single patients.

  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.

  From inclusion to week 52.

• Phase 2: Associations between data on Fear of Cancer Recurrence and age in single patients.

  From inclusion to week 52.

• Phase 2: Associations between data on Fear of Cancer Recurrence and educational level in single patients.

  From inclusion to week 52.

Other Outcomes (7)

• Phase 2: Investigate the association between Fear of Cancer Recurrence within couples (patient and partner/spouse).

  From inclusion to week 52.

• Phase 2: Comparison between Fear of Cancer Regression in single patients and patients living in a relationship.

  From inclusion to week 52.

• Phase 2: Between-group differences of age distribution

  At enrollment.

Study Arms (2)

Panel members

6 patients with spouses/partners and 3 single patients. In total 15 subjects.

Other: Phase 1: Establishment of a patient-partner panel

Pilot population

In total 90 subjects (patients with or without partners)

Other: Phase 2: Feasibility testing of FCR questions, mode of administration and timing for investigating Fear of Cancer Recurrence

Interventions

Phase 1: Establishment of a patient-partner panel OTHER

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).

Panel members

Phase 2: Feasibility testing of FCR questions, mode of administration and timing for investigating Fear of Cancer Recurrence OTHER

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.

Pilot population

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and partners who fullfil the in- and exclusion criteria and are consulting urologists at Aalborg University Hospital, Aarhus University Hospital and Gødstrup Hospital, Denmark

You may qualify if:

• Phase 1:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigitta Rasmussen Villumsen: lead
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator

Study Sites (3)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Gødstrup Hospital

Herning, 7400, Denmark

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Brigitta R Villumsen, PhD

  Gødstrup Hospital

  STUDY CHAIR

Central Study Contacts

Brigitta R Villumsen, PhD

CONTACT

+45 20487820; brigvill@rm.dk

Anne H Nielsen, PhD

CONTACT

+45 2015 8924; annsve@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: November 18, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2025-11

Locations

DK (3)