Fear of Cancer RecurrencePP-RECURKNCT07234656
Patient-partnered Research in Investigating Fear of Cancer Recurrence in Kidney Cancer
An observational study of Fear of Cancer Recurrence and Renal Cell Carcinoma (Kidney Cancer), run by Brigitta Rasmussen Villumsen at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fear of Cancer Recurrence, Renal Cell Carcinoma (Kidney Cancer)
- What is being tested?
- Phase 1: Establishment of a patient-partner panel and Phase 2: Feasibility testing of FCR questions, mode of administration and timing for investigating Fear of Cancer Recurrence
- How many people
- 105 participants
- Where
- 3 sitesDenmark
- Study dates
- 30 Sep 2025to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Tommy K Nielsen, PhD, +45 97656359, t.kjaergaard@rn.dk
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Anna K Keller, PhD, + 45 2029 8015, anna.keller@clin.au.dk
- Recruiting
Gødstrup Hospital
Herning, 7400
Mette S Olesen, MSN
Brigitta R Villumsen, PhD, +45 20487820
About this study
Official title: Patient-partnered Research: a Key to Investigating Fear of Cancer Recurrence in Patients With Surgically Treated Kidney Cancer (PP-RECURK)
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.
Read the detailed description
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.
- Being tested
- Phase 1: Establishment of a patient-partner panel, Phase 2: Feasibility testing of FCR questions, mode of administration and timing for investigating Fear of Cancer Recurrence
- Keywords
- Fear of Cancer Recurrence, Patient involvement in research, Kidney cancer
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1: Establishment of a patient-partner panelOther
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 RecurrenceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Panel members | 6 patients with spouses/partners and 3 single patients. In total 15 subjects. Receives: Other: Phase 1: Establishment of a patient-partner panel | |
| Pilot population | In total 90 subjects (patients with or without partners) Receives: Other: Phase 2: Feasibility testing of FCR questions, mode of administration and timing for investigating Fear of Cancer Recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Logistic regression analysis will be conducted to investigate associations between Fear of Cancer Recurrence and disease stage: Leibovich disease risk groups (low, medium, and high) .
The Fear of Cancer Recurrence Inventory will be used to measure Fear of Cancer Recurrence (FCR). Higher score means higher FCR. The score range from 0-168.
Measured: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and comorbidity burden in single patients.
Logistic regression analysis will be conducted to investigate associations between Fear of Cancer Recurrence and Charlson Comorbidity Index score.
The Fear of Cancer Inventory will be used to measure FCR. Higher score means higher FCR. The score ranges from 0-168.
Measured: 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.
Logistic regression analyses will be conducted to investigate associations.
Measured: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and age in single patients.
Logistic regression analyses will be conducted to investigate associations.
Measured: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and educational level in single patients.
Logistic regression analyses will be conducted to investigate associations.
Measured: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and disease stage in patients with a partner/spouse.
Logistic regression analyses will be conducted to investigate associations.
Measured: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and comorbidity burden in patients with a partner/spouse.
Logistic regression analyses will be conducted to investigate associations between Fear of Cancer Recurrence score and Charlson Comorbidity Index score.
Measured: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and sex in patients with a partner/spouse.
Logistic regression analyses will be conducted to investigate associations.
Measured: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and age in patients with a partner/spouse.
Logistic regression analyses will be conducted to investigate associations.
Measured: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and educational level in patients with partner/spouse.
Logistic regression analyses will be conducted to investigate associations.
Measured: 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.
Logistic regression analyses will be conducted to investigate associations between data on Fear of Cancer Recurrence and patients' disease stage: Leibovich disease risk groups (low, medium, and high).
Measured: 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.
Logistic statistical analyses will be conducted to investigate associations.
Measured: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and sex of partners/spouses among non-single patients.
Logistic regression analyses will be conducted to investigate associations.
Measured: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and age of partners/spouses among non-single patients.
Logistic regression analyses will be conducted to investigate associations.
Measured: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and educational level in partners/spouses of non-single patients.
Logistic regression analyses will be conducted to investigate associations.
Measured: From inclusion to week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start30 Sep 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Fear of Cancer RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigitta Rasmussen Villumsen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital
- Responsible party
- Sponsor-investigator, Brigitta Rasmussen Villumsen, Gødstrup Hospital
- Investigators
- Brigitta R Villumsen, PhD, Study chair, Gødstrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234656
- Sponsor's protocol ID
- 1-16-02-314-25
- Acronym
- PP-RECURK
- Status last verified
- Nov 2025
- First submitted
- 6 Aug 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yet to be discussed in the steering group
Publications
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.
PubMed 33729634Glasgow 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.
PubMed 10474547Roberts 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.
PubMed 27001093Altman M, Huang TTK, Breland JY. Design Thinking in Health Care. Prev Chronic Dis. 2018 Sep 27;15:E117. doi: 10.5888/pcd15.180128.
PubMed 30264690Simard 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.
PubMed 18414902Smith 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.
PubMed 34762248Bergerot 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.
PubMed 32955409
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-partnered Research: a Key to Investigating Fear of Cancer Recurrence in Patients With Surgically Treated Kidney Cancer (PP-RECURK)
- ClinicalTrials.gov ID
- NCT07234656
- Acronym / sponsor ID
- PP-RECURK / 1-16-02-314-25
- Keywords
- Fear of Cancer Recurrence, Patient involvement in research, Kidney cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Brigitta Rasmussen VillumsenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panel members | – | Other: Phase 1: Establishment of a patient-partner panel6 patients with spouses/partners and 3 single patients. In total 15 subjects. |
| Pilot population | – | Other: Phase 2: Feasibility testing of FCR questions, mode of administration and timing for investigating Fear of Cancer RecurrenceIn total 90 subjects (patients with or without partners) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (5 listed)
- Diagnosed with cognitive impairment
- Untreated psychiatric disorders due to non-compliance
- Patients and partners/spouses who were panelists in phase 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase 1: Establishment of a patient-partner panelPhase 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). | Other | Panel members |
| Phase 2: Feasibility testing of FCR questions, mode of administration and timing for investigating Fear of Cancer RecurrenceAs 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. | Other | Pilot population |
Primary outcome
Phase 1: Assessment of the recruitment to and composition the patient-partner panel
Time frame: From inclusion to week 16 or date of last subject included whichever comes first.
The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework will be applied for the assessment of the recruitmentprocess, eligibility of panelists and their representativity.
Phase 1: Assessment of the degree of patient and partner/spouse involvement
Time frame: From inclusion to week 26 or end of engagement whichever comes first.
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
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,
Time frame: From inclusion to week 52.
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.
Phase 2: The prevalence of Fear of Cancer Recurrence in single patients with localized Renal Cell Carcinoma
Time frame: From inclusion to week 52 or when the subject withdraws from the study whichever comes first.
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.
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.
Time frame: From inclusion to week 52 or when the subject withdraws from the study whichever comes first.
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.
Phase 2: The prevalence of Fear of Cancer Recurrence in partners/spouses to patients with localized Renal Cell Carcinoma.
Time frame: From inclusion to week 52 or when the subject withdraws from the study whichever comes first.
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.
15 secondary outcomes
Phase 2: Associations between data on Fear of Cancer Recurrence and disease stage in single patients.
Time frame: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and comorbidity burden in single patients.
Time frame: 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.
Time frame: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and age in single patients.
Time frame: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and educational level in single patients.
Time frame: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and disease stage in patients with a partner/spouse.
Time frame: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and comorbidity burden in patients with a partner/spouse.
Time frame: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and sex in patients with a partner/spouse.
Time frame: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and age in patients with a partner/spouse.
Time frame: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and educational level in patients with partner/spouse.
Time frame: 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.
Time frame: 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.
Time frame: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and sex of partners/spouses among non-single patients.
Time frame: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and age of partners/spouses among non-single patients.
Time frame: From inclusion to week 52.
Phase 2: Associations between data on Fear of Cancer Recurrence and educational level in partners/spouses of non-single patients.
Time frame: From inclusion to week 52.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 33729634Hamilton 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.
- Background: PubMed 10474547Glasgow 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.
- Background: PubMed 27001093Roberts 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.
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- Individual participant dataSharing planned: Undecided. Yet to be discussed in the steering group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brigitta R Villumsen, PhD study chair
Gødstrup Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fear of Cancer Recurrence and Renal Cell Carcinoma (Kidney Cancer), run by Brigitta Rasmussen Villumsen at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brigitta R Villumsen, PhD (+45 20487820, brigvill@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Assessment of the recruitment to and composition the patient-partner panel (time frame: From inclusion to week 16 or date of last subject included whichever comes first.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07234656, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.