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Abstract
Introduction Symptom monitoring and alerting based on patient-reported outcomes have proven valuable in a postoperative setting. However, the parameters of the implemented patient-centred symptom management system for patients with prostate cancer (PC) remain unclear. This study aims to develop a perioperative symptom scale (PSS) to monitor symptoms, determine the appropriate timing for symptom assessment and establish intervention criteria for physicians.
Methods and analysis We will prospectively recruit 387 patients undergoing PC surgery in 3 hospitals. The Chinese version of the MD Anderson Symptom Inventory (MDASI) will be used for longitudinal symptom data collection, presurgery and 1, 2, 3, 5, 7, 14, 21, 28, 42 and 90 days post surgery. A PSS will be generated when symptoms change significantly over time. A linear mixed model will be used to determine appropriate follow-up time points. The functional status determined by MDASI interference can then be used to establish alarm thresholds.
Ethics and dissemination This study was approved by the Lishui Municipal Central Hospital Ethics Committee on 13 April 2022 (No. LSMCHEC-2022-54) and the Ethics Committee of Huzhou Central Hospital on 5 July 2023 (No. HZCHEC-202306017-01), the Ethics Committee of the First Affiliated Hospital of Huzhou Normal College on 20 June 2023 (No. HZYYEC-2023KYLL055). The latest protocol used in this study was V.2.0, dated on 25 February 2023. Before publication in a peer-reviewed journal, our findings will be presented and discussed at relevant medical conferences.
Trial registration number ChiCTR2200059110.
- Prostatic Neoplasms
- Quality of Life
- SURGERY
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STRENGTHS AND LIMITATIONS OF THIS STUDY
This study is a prospective multicentre real-world analysis to be conducted in China.
It focuses on developing and validating of utility parameters for future implementation of patient-reported outcome-based perioperative symptom management in patients with prostate cancer.
It focuses on collecting frequent longitudinal symptom data before and after surgery, both during hospital stay and up to 90 days after discharge.
Two subcentres joining midway through the study may affect data collection and analysis.
Introduction
Prostate cancer (PC) is the second most prevalent cancer and fifth leading cause of cancer-related mortality in men.1 In 2020, 1.4 million cases of PC were reported worldwide, resulting in an estimated 375 000 deaths, its incidence is increasing rapidly in China as well.2 Radical prostatectomy (RP) is a commonly used treatment for organ-confined cancer; however, it may lead to severe and diverse perioperative symptoms, including pain, dyspnoea, nausea, vomiting and fever.3–7 Improving perioperative symptom control could enhance recovery speed, shorten postoperative hospital stay and reduce readmission rates during the acute postoperative period.8 In patients receiving chemotherapy for metastatic cancer, patient-reported outcomes (PROs) have been associated with better quality of life (QOL), fewer emergency hospital visits, reduced emergency room admission rates, longer retention on chemotherapy and higher survival rates.9 10 PRO-based symptom management has been identified as the most efficient and effective technique for patient-centred care.11–13 Previous studies have primarily focused on long-term symptoms and QOL after RP.14–17 However, limited research has been conducted on patients with PC in the perioperative period.3 18 19 Additionally, methodological issues have hindered the development of PRO tools for perioperative symptom management in patients undergoing RP. First, there is a lack of a specific measurement scale for RP. Currently, several common PC-specific PRO tools exist, including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Prostate-Specific 25-item, University of California–Los Angeles Prostate Cancer Index, Functional Assessment of Cancer Therapy Prostate Cancer Subscale, Expanded Prostate Cancer Index Composite-26, Prostate Cancer–Quality of Life, Expanded Prostate Cancer Index Composite-50, Symptom Tracking and Reporting, Recovery Tracker and MD Anderson Symptom Inventory (MDASI).3 14–17 20–24 These scales primarily focus on urinary symptoms, sexual function, hormonal symptoms, bowel function and overall QOL and have been developed and verified in men who underwent surgery or pharmacotherapy. However, the suitability of these items for perioperative use has not yet been assessed. Additionally, the completion of multiple items can be time-consuming and energy-consuming, resulting in decreased accuracy and quality. Second, determining appropriate time points for monitoring key symptom during the perioperative period remains uncertain. For discharged patients, PRO data collection was usually limited to subsequent clinical visits. However, between discharge and the first clinic visit, approximately 1 month after discharge, rapid changes in symptoms and functional status may occur, leading to postsurgical complications and unplanned clinic or emergency room visits.3 The absence of key PRO information can affect the evaluation of clinical outcomes.25 Third, no consensus currently exists on alert thresholds for perioperative interventions. Patient symptom monitoring relies on clear cut-off points for symptom scores, followed by precise medical treatment. In this study, we aim to address these methodological difficulties by establishing and validating a perioperative symptom scale (PSS) that enables monitoring of symptoms, determination of the appropriate timing for symptom assessment and setting intervention criteria for physicians.
Methods and analysis
Study design
This is a real-world, prospective, observational and ongoing cohort study. The flow diagram of the study is shown in figure 1.
Flow diagram of this study.
Setting
The study will be conducted in three Chinese hospitals: Lishui Municipal Central Hospital, the First Affiliated Hospital of Huzhou Normal College and Huzhou Central Hospital. The study was initiated by the Lishui Municipal Central Hospital in April 2022 and the other two research centres joined later. The estimated completion date for this study is 31 March 2025.
Study population
The inclusion criteria are as follows: age>18 years, without cognitive impairment, diagnosis of PC and plans to undergo RP.
Sample size calculation
This study aims to establish a symptom scale to monitor the perioperative symptom burden among patients with PC, which changes over the perioperative period (before surgery to 90 days after surgery). Before study initiation, 11 patients who underwent RP at Lishui Municipal Central Hospital in January 2022 were investigated and followed-up, and the SD for the main PC symptoms (scored from 0 to 10) at 90 days postoperatively was 0.63. Sample size calculation was performed using the Power Analysis and Sample Size V.15 software and a linear regression model. Based on the slope of the symptom score per assessment of 0.1 with an average of four assessments, it was determined that 309 patients with accurate symptom data were needed to reject the claim that the symptom scale did not significantly vary over time. With a power of 80% and a type-I error rate of 5%, accounting for a 20% loss, the final sample size was estimated to be approximately 387 patients (309/0.8).
Outcome measures
The main outcome measure of this study is perioperative symptom burden in patients with PC, assessed using the MDASI symptom item subgroup that changes considerably perioperatively. The MDASI is used for longitudinal symptom data collection 3 days before surgery and 1, 2, 3, 5, 7, 14, 21, 28, 42 and 90 days after surgery. The MDASI is a cancer PRO assessment tool translated and validated in China. The main secondary outcomes are QOL assessed using the UNISCALE, a single-item QOL scale,26 and functional status assessed using MDASI interference items. QOL and MDASI are measured at the same time points.
Withdrawal criteria
The exclusion criteria for the study include surgery cancellation, endotracheal intubation 气管插管 Bing translation waiting t in the ICU for >24 hours following surgery, hospital stay exceeding 14 days, serious complications that hinder accurate PRO data collection, a postoperative pathological diagnosis other than PC, intentional provision of incorrect data by patients, patient request for exclusion from the study and other conditions as assessed by the investigators.
Data collection, management and monitoring
Data collection and management are performed using Jinyinhua, a software system for storing and managing data. The system consists of 11 data collection tools, including information on preoperative characteristics, demographic characteristics, anaesthesia, surgery details, perioperative complications, postoperative care, pain management, QOL, MDASI, completion data and follow-up information. PRO data collection is conducted using paper or electronic questionnaires, which are then uploaded to Jinyinhua. All participants are instructed to complete for the questionnaires independently, with the option to seek assistance from investigators or family members if needed. The data are uploaded to Jinyinhua after deidentification. Regular data checks are conducted by a quality controller, and data usage is approved by the Lishui Municipal Central Hospital Ethics Committee.
Quality control
Prior to patient recruitment, the investigators received comprehensive training on standard operating procedures. Subcentres received regular online guidance, telephone monitoring and on-site supervision from the main investigators to ensure quality control.
Data analysis
For inclusion in the final analysis, a minimum of two MDASI assessments after surgery and one before surgery are required. Missing data will be imputed using the multiple imputation method. Continuous data are expressed as mean±SD or median and IQR, whereas categorical data are presented as numbers and percentages. Linear mixed models are used to describe the trajectories of symptom severity, symptom interference and QOL over the study period. Perioperative symptom monitoring targets will be generated based on significant changes in symptom scores using time and days from surgery as continuous variables. The PSS Score will be determined by calculating the average score of the selected symptoms.
Categorical variables such as number of days from surgery will be used to assess PSS changes from the prior assessment. Optimal monitoring points will be identified when PSS changes significantly. Alarm thresholds will be created as cut-off points for the PSS using the method suggested by Serlin et al,27 using the six MDASI interference items as anchors. This has been proven to be a valid and reliable way to assess patients’ functional status during cancer treatment.28 29 This method further holds importance as international professionals have named functional recovery the most critical aspect of postsurgical recovery.30 Statistical significance is set at p<0.05. The SAS V.9.4 software is used to analyse the data.
Patient and public involvement
Patients and the general public are not involved in the design, recruitment or implementation of this study. The study results will not be disclosed to the participants; however, they will be communicated to study applicants through a published article.
Ethics and dissemination
This study was approved by the Ethics Committee of Lishui Municipal Central Hospital on 13 April 2022 (No. LSMCHEC-2022-54), the Ethics Committee of Huzhou Central Hospital on 5 July 2023 (No. HZCHEC-202306017-01) and the Ethics Committee of the First Affiliated Hospital of Huzhou Normal College on 20 June 2023 (No. HZYYEC-2023KYLL055). The ethics committees will review any modifications to the protocol. Informed consent is required from all participants. Before publication in a peer-reviewed journal, its findings will be discussed at relevant medical conferences.
Ethics statements
Patient consent for publication
Acknowledgments
We thank all participants and advisors involved in this study. We would like to thank Editage (www.editage.cn) for English language editing.
References
Footnotes
Contributors JL contributed to the study design. TC, JG, FP and TG performed the study. JL and TC drafted the manuscript. BJ revised the draft. All authors have reviewed and approved the final manuscript.
Funding This study was supported by the Zhejiang Medical and Health Science Project (grant number: 2023RC114 to JL).
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.