Purpose: The purpose of this study is to evaluate the role of renal mass biopsy on decision-making for patients presenting with clinical T1 kidney tumors. This study also incorporates integrated biomarker study to compare the genomic data obtained through biopsy tissue to genomic information from surgical data.
Primary Objective 1. To compare the decisional conflict between patients who undergo renal mass biopsy during their evaluation for SRMs versus those who do not. 2. To validate the concordance of RNA sequencing (RNAseq) and genomic-based risk stratification molecular biomarkers between renal biopsy tissue and surgical (nephrectomy) specimen tissue. Secondary objective 1\. To characterize the impact of biopsy on patient reported anxiety and uncertainty, assessment of cancer care communication, and satisfaction with cancer care.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
265
Subjects will receive a small renal mass biopsy prior to making a treatment decision
Subjects will not receive a small renal mass biopsy prior to making a treatment decision
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Change in Decisional Conflict
Decisional conflict scale between patients who undergo renal mass biopsy, and who do not will be compared. Decisional conflict scale is a validated, 16-item instrument that measures personal perceptions of decision-making. It yields a total score from 0 to 100 (higher scores indicate more decisional conflict) and sub-scores for perceptions of uncertainty, informed values clarity, support, and effectiveness in decision-making.
Time frame: Baseline, 1-3 months (before treatment)
Receipt of nephrectomy
The proportion of patients undergoing nephrectomy (radical and partial nephrectomy) between patients who undergo renal mass biopsy versus those who do not will be compared.
Time frame: 1-3 months (index treatment), 2 years
Genomic mutations comparison
Molecular subtype (ccA vs ccB) and the presence of genomic mutations between the renal mass biopsy and the surgical nephrectomy specimen will be compared.
Time frame: 2 years
Patient-reported anxiety
Patient-reported anxiety will be assessed using the Short Form PROMIS Anxiety scale. Short Form PROMIS Anxiety is a validated 4-item survey of generalized anxiety, consisting of 5 questions, each scored using a 5-point Likert scale. High scores reflect better results.
Time frame: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
Patient-reported cancer worry
Patient-reported cancer worry will be assessed using the Brief Worry Scale which is a 4 questions assessment designed to measure the relationship between worry and an event or behavior. This study will use the brief worry scale to measure the relationship between worry and the diagnosis of a small renal mass.
Time frame: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
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Patient-Reported Risk Perception
Patient-reported Risk Perception will be assessed using 2 two-question instrument to assign a numeric risk score for patients regarding incidental renal lesions, which may facilitate accurate risk comprehension.
Time frame: Baseline, 1-3 months (before treatment)
Patient-reported uncertainty based on Short-Form Mishel Uncertainty of Illness Scale
Patient-reported uncertainty will be assessed using the Short-Form Mishel Uncertainty of Illness Scale which is a validated instrument that measures the patient's perception of the uncertainty of symptoms, diagnosis, treatment, and prognosis as well as the uncertainty subscale of the Decisional Conflict Scale. The scores are summed to yield a total score with a higher score indicating greater uncertainty.
Time frame: baseline, 1-3 months (before treatment)
Patient-reported regret about the decision
Patient-reported regret about the decision will be assessed using the Decisional regret scale. Decisional Regret scale is a 5-item regret scale that measures distress or remorse after a healthcare decision. The short form consists of 5 questions, each scored using a 5-point Likert scale, indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree).
Time frame: 6, 12, 18, 24 months
Patient-reported health-related quality of life
Patient-reported health-related quality of life will be assessed using The PROMIS Global Health scale is an 8-item, validated survey that represents five core PROMIS domains (physical function, pain, fatigue, emotional distress, social health). Higher score indicating better quality of life.
Time frame: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
Patient reported assessment of communication in cancer care
The validated 6-item Short-Form for Patient-Centered Communication-Cancer Scale. This is a validated, 6-item instrument that measures the patient's perspective on communication in cancer care. It incorporates questions relating to exchanging information, fostering relationships, making decisions, responding to emotions, enabling self-efficacy, and managing uncertainty. Each item is scored 1-5, and the overall score is an average of 6 questions, with 5 indicating the most satisfaction. A high score indicates better communication.
Time frame: Baseline, 1-3 months (before treatment)
Receipt of any intervention (ablation, radiation therapy, nephrectomy)
The proportion of patients undergoing ablation, radiation therapy, nephrectomy between patients who undergo renal mass biopsy versus those who do not will be compared
Time frame: 1-3 months (index treatment), 2 years