NCT Number: NCT07234656
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.
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Observational
Aalborg University Hospital, Aalborg, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Phase 1:
Phase 2:
Exclusion criteria
Both phases, both patients and partners/spouses:
Phase 2:
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).
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.
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.
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
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.
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.
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.
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.
Time frame: From inclusion to week 52.
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.
Time frame: From inclusion to the study to week 52 or when the subject withdraws consent whichever comes first.
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.
Time frame: From inclusion to week 52.
Logistic regression analyses will be conducted to investigate associations.
Time frame: From inclusion to week 52.
Logistic regression analyses will be conducted to investigate associations.
Time frame: From inclusion to week 52.
Logistic regression analyses will be conducted to investigate associations.
Time frame: From inclusion to week 52.
Logistic regression analyses will be conducted to investigate associations.
Time frame: From inclusion to week 52.
Logistic regression analyses will be conducted to investigate associations between Fear of Cancer Recurrence score and Charlson Comorbidity Index score.
Time frame: From inclusion to week 52.
Logistic regression analyses will be conducted to investigate associations.
Time frame: From inclusion to week 52.
Logistic regression analyses will be conducted to investigate associations.
Time frame: From inclusion to week 52.
Logistic regression analyses will be conducted to investigate associations.
Time frame: From inclusion to week 52.
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).
Time frame: From inclusion to week 52.
Logistic statistical analyses will be conducted to investigate associations.
Time frame: From inclusion to week 52.
Logistic regression analyses will be conducted to investigate associations.
Time frame: From inclusion to week 52.
Logistic regression analyses will be conducted to investigate associations.
Time frame: From inclusion to week 52.
Logistic regression analyses will be conducted to investigate associations.
Time frame: From inclusion to week 52.
For the investigation of the association between Fear of Cancer Recurrence (FCR) within couples (patient and partner) ideally the Actor-Partner Interdependence Model (APIM) will be applied. Alternatively, a Multilevel Model (MLM) can be applied if couples are treated as clusters to account for the dependent FCR scores between partners/spouses.
The Fear of Cancer Inventory will be used to determine FCR. Higher score represents higher level of FCR. The score ranges from 0-168.
Time frame: From inclusion to week 52.
To compare the Fear of Cancer Recurrence score between single patients and patients in relationship, the Mann-Whitney U test will be applied.
The Fear of Cancer Inventory will be used to to determine FCR. Higher score represents higher level of FCR. The score ranges from 0-168.
Time frame: At enrollment.
Data on age will be presented as mean ± standard deviation and the independent t-test will be applied to investigate between-group differences (single patients vs. patients in a relationship vs. partner/spouse).
Time frame: At enrollment.
Data on sex will be presented as frequency with percentage using. Chi Square test will be applied to investigate between-group differences (single patients vs. patients in a relationship vs. partner/spouse).
Time frame: At enrollment.
Data on educational level will be presented as frequency with percentages. Chi Square test will be applied to investigate between-group differences (single patients vs. patients in a relationship vs. partner/spouse).
Time frame: At enrollment.
Data on disease stage by Leibovich disease risk groups (low, medium, and high) be presented as frequency and percentages. To investigate between-group differences (single patients vs. patients in a relationship) the Chi Square test will be applied
Time frame: At enrollment.
The Charlson Comorbidity Index will be applied to investigate disease burden in single patients versus non-single patients. The higher the score, the worse the prognosis.
0 points: No comorbidities are present. 1-2 points: Moderate comorbidity. 3 points or above: Severe comorbidity. Data will be presented as frequency and percentages.
Contact information is provided by the study sponsor or research team.
Anne H Nielsen, PhD
CONTACT
Brigitta R Villumsen, PhD
CONTACT
Brigitta Rasmussen Villumsen
Other
Patient-partnered Research: a Key to Investigating Fear of Cancer Recurrence in Patients With Surgically Treated Kidney Cancer (PP-RECURK)
Acronym: PP-RECURK
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