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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Eligibility

Primary outcome measure(s)

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

Trial sites (3)