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

ConditionsFear of Cancer Recurrence Renal Cell Carcinoma (Kidney Cancer)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorBrigitta Rasmussen Villumsen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Diagnosed with cognitive impairment

Untreated psychiatric disorders due to non-compliance

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Phase 1: Establishment of a patient-partner panel
Other intervention
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 Recurrence
Other intervention
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.

Treatment groups

105 Participants

are divided into 2 treatment groups

Group A: Panel members1 intervention

Group B: Pilot population1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Time frame

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.

Time frame

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.

Time frame

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

Secondary outcomes

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.

Time frame

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.

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.

Logistic regression analyses will be conducted to investigate associations.

Time frame

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.

Time frame

From inclusion to week 52.

Other outcomes

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

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.

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

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

From inclusion to week 52.

Phase 2: Between-group differences of age distribution

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.

Phase 2: Between-group differences in gender distribution

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.