Patient-partnered Research: a Key to Investigating Fear of Cancer Recurrence in Patients With Surgically Treated Kidney Cancer (PP-RECURK)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 3
- 主要终点
- Phase 1: Assessment of the recruitment to and composition the patient-partner panel
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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
排除标准
- •Both phases, both patients and partners/spouses:
- •Diagnosed with cognitive impairment
- •Untreated psychiatric disorders due to non-compliance
- •Patients and partners/spouses who were panelists in phase 1
结局指标
主要结局
Phase 1: Assessment of the recruitment to and composition the patient-partner panel
时间窗: 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 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,
时间窗: 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
时间窗: 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 1: Assessment of the degree of patient and partner/spouse involvement
时间窗: 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: The prevalence of Fear of Cancer Recurrence in patients with localized Renal Cell Carcinoma and living in a relationship with a partner/spouse.
时间窗: 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.
时间窗: 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.
次要结局
- Phase 2: Associations between data on Fear of Cancer Recurrence and disease stage in single patients.(From inclusion to week 52.)
- Phase 2: Associations between data on Fear of Cancer Recurrence and comorbidity burden in single patients.(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.(From inclusion to week 52.)
- Phase 2: Associations between data on Fear of Cancer Recurrence and age in single patients.(From inclusion to week 52.)
- Phase 2: Associations between data on Fear of Cancer Recurrence and educational level in single patients.(From inclusion to week 52.)
- Phase 2: Associations between data on Fear of Cancer Recurrence and disease stage in patients with a partner/spouse.(From inclusion to week 52.)
- Phase 2: Associations between data on Fear of Cancer Recurrence and comorbidity burden in patients with a partner/spouse.(From inclusion to week 52.)
- Phase 2: Associations between data on Fear of Cancer Recurrence and sex in patients with a partner/spouse.(From inclusion to week 52.)
- Phase 2: Associations between data on Fear of Cancer Recurrence and age in patients with a partner/spouse.(From inclusion to week 52.)
- Phase 2: Associations between data on Fear of Cancer Recurrence and educational level in patients with partner/spouse.(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.(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.(From inclusion to week 52.)
- Phase 2: Associations between data on Fear of Cancer Recurrence and sex of partners/spouses among non-single patients.(From inclusion to week 52.)
- Phase 2: Associations between data on Fear of Cancer Recurrence and age of partners/spouses among non-single patients.(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.(From inclusion to week 52.)
研究者
Brigitta Rasmussen Villumsen
Principal Investigator
Gødstrup Hospital