Patient-partnered Research in Investigating Fear of Cancer Recurrence in Kidney Cancer (NCT07234656) | Clinical Trial Compass
RecruitingNot Applicable
Patient-partnered Research in Investigating Fear of Cancer Recurrence in Kidney Cancer
Denmark105 participantsStarted 2025-09-30
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Assessment of the recruitment to and composition the patient-partner panel
Timeframe: From inclusion to week 16 or date of last subject included whichever comes first.
2
Phase 1: Assessment of the degree of patient and partner/spouse involvement
Timeframe: From inclusion to week 26 or end of engagement whichever comes first.
3
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,
Timeframe: From inclusion to week 52.
4
Phase 2: The prevalence of Fear of Cancer Recurrence in single patients with localized Renal Cell Carcinoma
Timeframe: From inclusion to week 52 or when the subject withdraws from the study whichever comes first.
5
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.
Timeframe: From inclusion to week 52 or when the subject withdraws from the study whichever comes first.
6
Phase 2: The prevalence of Fear of Cancer Recurrence in partners/spouses to patients with localized Renal Cell Carcinoma.