Prospective Observational Study of the Association Between Daily Step Count and Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Total Neoadjuvant Therapy: STEP-R Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The rate of pathological complete response in rectal cancer patients receiving neoadjuvant therapy
研究概览
简要总结
This study aims to examine the impact of daily physical activity, specifically step count, on treatment outcomes and side effects in patients with locally advanced rectal cancer receiving total neoadjuvant therapy (chemotherapy and radiotherapy before surgery). Using Huawei Watch Fit 2 smartwatches, we will track participants' daily step counts, heart rate, and sleep quality.
The primary hypothesis is that higher step counts and physical activity levels correlate with higher rates of complete pathological response at surgery. A secondary hypothesis is that increased physical activity may be associated with fewer or less severe side effects during treatment.
Participants will wear a smartwatch and complete the EORTC QLQ-C30 Quality of Life Questionnaire and the Pittsburgh Sleep Quality Index at the beginning and end of treatment. Data from the smartwatch, including step count, heart rate changes, and sleep duration, will be reviewed weekly during routine visits.
Approximately 200 patients with rectal cancer will participate, and each will be followed from the start of therapy until surgery (around 4-6 months). Total data collection is expected to take 12-15 months.
This study could improve cancer care by identifying links between physical activity and treatment outcomes, supporting future exercise guidelines for oncology patients.
详细描述
Background and Rationale Rectal cancer treatment includes a multimodal approach, often involving total neoadjuvant therapy (TNT), which combines chemotherapy and radiotherapy before surgical intervention. While physical activity, particularly walking, has shown general health benefits for cancer patients, the specific effects of objectively measured daily activity on treatment outcomes, such as response rates and side effect incidence, remain insufficient. Current methods for assessing physical activity largely rely on self-reported data, which can be less accurate. This study uses wearable technology (Huawei Watch Fit 2 smartwatches) to gather objective, real-time data on patients' physical activity, offering a novel approach to tracking exercise and health metrics throughout cancer treatment.
Study Objectives Primary Objective: To determine whether higher physical activity levels, specifically daily step counts, are associated with increased complete pathological response rates in rectal cancer patients undergoing TNT.
Secondary Objectives:
To evaluate the relationship between physical activity (step count) and the frequency and severity of treatment-related side effects.
To assess changes in sleep quality and heart rate as additional metrics of physical well-being and their potential influence on treatment tolerance and outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older.
- •Diagnosed with locally advanced rectal cancer (stage II or III) and eligible for total neoadjuvant therapy (TNT).
- •Planned to undergo chemotherapy and radiotherapy as part of neoadjuvant treatment before surgery.
- •Capable of providing informed consent.
- •Able to wear and operate the Huawei Watch Fit 2 smartwatch throughout the treatment period.
- •Sufficient mobility to engage in physical activity, including walking, as per study requirements.
- •Willing to complete weekly monitoring visits and complete the EORTC QLQ-C30 and Pittsburgh Sleep Quality Index questionnaires at baseline and study end
排除标准
- •Stage I or metastatic (stage IV) rectal cancer.
- •Contraindications to physical activity, including but not limited to severe cardiovascular or respiratory conditions that limit mobility.
- •Prior treatment for rectal cancer with chemotherapy or radiotherapy.
- •Use of a pacemaker or other implanted medical devices that might interfere with smartwatch functionality.
- •Known allergic reaction to materials in the Huawei Watch Fit 2 smartwatch.
- •Severe cognitive or psychological disorders that would hinder participation in the study or completion of questionnaires.
- •Any medical or psychiatric condition that, in the opinion of the investigator, may compromise patient safety or interfere with study adherence.
结局指标
主要结局
The rate of pathological complete response in rectal cancer patients receiving neoadjuvant therapy
时间窗: 9 months
This outcome measure assesses the relationship between daily physical activity levels, specifically step count, and the rate of pathological complete response (pCR) in rectal cancer patients undergoing neoadjuvant therapy. By tracking patients' step counts throughout the treatment period, we aim to investigate whether higher physical activity levels correlate with a higher likelihood of achieving a pCR, defined as no residual tumor in resected tissue at the time of surgery.
次要结局
未报告次要终点
研究者
Orhun Akdoğan
Principal Investigator
Gazi University