Renal cell carcinoma (RCC) metastasis portends a poor prognosis and cannot be reliably predicted. Early determination of the metastatic potential of RCC may help guide proper treatment. We analyzed microRNA (miRNA) expression in clear cell RCC (ccRCC) for the purpose of developing a miRNA expression signature to determine the risk of metastasis and prognosis. We used the microarray technology to profile miRNA expression of 78 benign kidney and ccRCC samples. Using 28 localized and metastatic ccRCC specimens as the training cohort and the univariate logistic regression and risk score methods, we developed a miRNA signature model in which the expression levels of miR-10b, miR-139-5p, miR-130b and miR-199b-5p were used to determine the status of ccRCC metastasis. We validated the signature in an independent 40-sample testing cohort of different stages of primary ccRCCs using the microarray data. Within the testing cohort patients who had at least 5 years follow-up if no metastasis developed, the signature showed a high sensitivity and specificity. The risk status was proven to be associated with the cancer-specific survival. Using the most stably expressed miRNA among benign and tumorous kidney tissue as the internal reference for normalization, we successfully converted his signature to be a quantitative PCR (qPCR)-based assay, which showed the same high sensitivity and specificity. The 4-miRNA is associated with ccRCC metastasis and prognosis. The signature is ready for and will benefit from further large clinical cohort validation and has the potential for clinical application.

Importance A combined objective and subjective wireless monitoring program of patient-centered outcomes can be carried out in patients before and after major abdominal surgery. Objective To conduct a proof-of-concept study of a wireless, patient-centered outcomes monitoring program before and after major abdominal cancer surgery. Design Patients wore wristband pedometers and completed online patient-reported outcome surveys (symptoms, QOL) 3 to 7 days before surgery, through hospitalization, and for two weeks post-discharge. Alerts were generated for all moderate to severe scores for symptoms and QOL. Surgery-related data was collected via electronic medical chart and complications were calculated using the Clavien-Dindo classification. Setting The study was carried out in the inpatient and outpatient surgical oncology unit of one NCI designated comprehensive cancer center. Participants Eligible patients were scheduled to undergo curative resection for hepatobiliary and gastrointestinal malignancies, English-speaking, and 18 years or older. Twenty participants were enrolled over 4 months. Main Outcomes and Measures Outcomes included 1) adherence with wearing the pedometer; 2) adherence with completing the surveys (MDASI and EQ-5D-5L), and 3) satisfaction with the monitoring program. Results Pedometer adherence (88% pre-op versus 83% post-discharge) was higher than survey adherence (75% completed). The median number of steps at day 7 was 1689 (19% of steps at baseline). This correlated with the comprehensive complication index (CCI), for which the median was 15/100 (r = −0.64, p<0.05). Post-discharge overall symptom severity (2.3/10) and symptom interference with activities (3.5/10) were mild. Pain, fatigue, and appetite loss were moderate after surgery (4.4, 4.7, 4.0). QOL scores were lowest at discharge (66.6/100), but improved at week 2 (73.9/100). While patient-reported outcomes returned to baseline at 2 weeks, the number of steps was only one third of pre-operative baseline. Conclusions and Relevance Wireless monitoring of combined subjective and objective patient-centered outcomes can be carried out in the surgical oncology setting. Pre- and post-operative patient-centered outcomes have the potential of identifying high risk populations who may need additional interventions to support postoperative functional and symptom recovery.

No abstract

Purpose This study evaluates the feasibility and acceptability of a Self-Management Survivorship Care Planning (SM-SCP) intervention in colorectal and lung cancer survivors. Methods This is a single-group, pre- and post-mixed methods study of an advance practice nurse-driven survivorship care intervention that integrates a survivorship care plan with self-management skills coaching. Colorectal and lung cancer survivors with stage I–III disease were enrolled at 3–6 months after completing treatments, and the intervention was administered in one in-person or telephone session. Survivor outcome measures included depression, anxiety, self-efficacy, QOL, and satisfaction. Paired t-tests were used for exploratory evaluations of pre- to post-intervention score changes. Content analysis was conducted to analyze the qualitative data to describe survivors’ experience with the intervention. Results Thirty participants (15 colorectal, 15 lung) enrolled and completed the study (73% retention). It took an average of 40 minutes to complete the TS/CP and 34.2 minutes to deliver the intervention. Exploratory analysis revealed significant differences from baseline to post-intervention in depression, anxiety, self-efficacy, physical functioning, role limitations-physical, pain, general health, health transition, physical health summary, and total QOL. Three qualitative themes emerged: 1) Feeling empowered about having a plan; 2) Struggling with psychosocial concerns; and 3) Suggestions for intervention content and delivery. Conclusions The SM-SCP intervention was feasible and acceptable for colorectal and lung cancer survivors after treatment completion. Survivorship care interventions have potential to fulfill the unmet needs of colorectal and lung cancer survivors. Their effectiveness might be greater by integrating conceptually-based models of care, such as self-management skills building.