Evaluating the Implementation, Utility, and Clinical Importance of the Patient-Reported Outcome Measure Information System (PROMIS) in Sarcoma Patients: A Multi-Centered Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 3
- 主要终点
- Gait asymmetry
研究概览
简要总结
The goal of this is to validate the Patient-Reported Outcomes Measurement Information System (PROMIS) in sarcoma patients undergoing surgery, and to evaluate a novel smartphone app for collecting mobility data. The goals of the study include to:
- Validate PROMIS as a patient outcome measure in sarcoma
- Assess the effectiveness of a novel app for administering questionnaires and collecting mobility metrics
- Compare PROMIS scores and mobility metrics to better evaluate recovery trajectories after surgery
Participants will complete PROMIS questionnaires at regularly scheduled intervals using the smartphone app. Questionnaires will be completed pre-operatively and at 6 weeks, 12 weeks, 6 months, and 12 months post-operatively. Additionally, the app will passively track mobility metrics such as daily step count, stairs climbed, and gait parameters to compare with PROMIS scores.
详细描述
Background & Rationale:
Sarcoma is a rare form of bone and soft tissue cancer, making up about 1% of all adult cancers. Management typically involves radiation therapy, chemotherapy, and surgical resection, with or without limb reconstruction. The diagnosis, intensive treatment regimen, and surgery-induced deficits significantly impact patient quality of life and function.
Evaluating outcomes in sarcoma is challenging due to disease heterogeneity, complexity, and variation in surgical strategy. Patient-reported outcomes measures are crucial for evaluating treatment outcomes and facilitating patient-centered care. Traditional validated PROMs, like the Toronto Extremity Salvage Score (TESS), have significant ceiling effects. PROMIS assesses physical, mental, and social well-being using item response theory in a standardized manner for precise and sensitive measures. PROMIS was developed with oncology research considerations and has been validated in both orthopaedic and oncology populations. However, the significance of PROMIS in orthopaedic oncology is not well understood.
Assessing patient reported outcomes is limited by survey completion rates, particularly in the oncology patients who have multiple medical appointments and care teams. To address these challenges, our team has developed ACTIVATION (Activity Capture To Investigate Voluntary ActiviTy In Orthopaedic populatioNs), a smartphone application (app) tailored to musculoskeletal oncology. Unlike general fitness or commercial health applications, ACTIVATION passively captures mobility metrics and remotely administers PROMIS questionnaires. The continuous data collection aligns real-world mobility with clinical recovery timelines, offering a more precise view of patient outcomes.
The overall aim of this study is to validate PROMIS in sarcoma patients undergoing surgery, and to evaluate a novel smartphone app for questionnaire administration and collection of mobility data.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosis of bone sarcoma, soft tissue sarcoma, or giant cell tumor of bone
- •Tumors located in the pelvis, lower extremities, or upper extremities
- •Primary or recurrent disease
- •Undergoing operative tumor resection, including limb salvage surgery and amputation
- •Has an iPhone or Android phone
- •Speaks English
排除标准
- •Metastatic bone tumor
- •Diagnosis of atypical lipomatous tumor or dermatofibrosarcoma protuberans
- •Currently pregnant or planning pregnancy within 6 months
- •Unwilling or unable to attend follow-up evaluations
- •Cognitive or communication barriers that impede completion of questionnaires
结局指标
主要结局
Gait asymmetry
时间窗: From enrolment to 1 year post-operative
Percentage
Flights of stairs climbed
时间窗: From enrolment to 1 year post-operative
Number of flights climbed
Step count
时间窗: From enrolment to one year post-operative
Number of steps
Distance travelled
时间窗: From enrolment to 1 year post-operative
Kilometers
Distinct activity periods
时间窗: From enrolment to 1 year post-operative
Number of distinct activity periods \>10 minutes
Total time active
时间窗: From enrolment to 1 year post-operative
Minutes
PROMIS Global Health
时间窗: From enrolment to 1 year post-operative
Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.
PROMIS Self Efficacy
时间窗: From enrolment to 1 year post-operative
Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.
PROMIS Pain Interference
时间窗: From enrolment to 1 year post-operative
Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.
PROMIS Physical Function
时间窗: From enrolment to 1 year post-operative
Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.
PROMIS Upper Extremity Function
时间窗: From enrolment to 1 year post-operative
Scored using standardized T-scores with a mean of 50 and a standard deviation of 10. Scores above 50 indicate more of the measured trait, while scores below 50 indicate less.
Toronto Extremity Salvage Score Lower Extremity
时间窗: From enrolment to 1 year post-operative
Sum of patient responses for each question on a 5-point Likert scale, excluding "not applicable" items. The sum is then divided by the maximum possible score and multiplyed by 100 to yield a final score between 0 and 100. A score of 100 indicates no functional disability and 0 indicates the worst functional disability.
Toronto Extremity Salvage Score Upper Extremity
时间窗: From enrolment to 1 year post-operative
Sum of patient responses for each question on a 5-point Likert scale, excluding "not applicable" items. The sum is then divided by the maximum possible score and multiplyed by 100 to yield a final score between 0 and 100. A score of 100 indicates no functional disability and 0 indicates the worst functional disability.
Maximal oxygen consumption (VO2 max)
时间窗: From enrolment to 1 year post-operative
Litres per minute. A higher VO2 max indicates that the body is more efficient at using oxygen to produce energy in the muscles.
Heart rate
时间窗: From enrolment to 1 year post-operative
Beats per minute
Heart rate variability
时间窗: From enrolment to 1 year post-operative
Milliseconds. Measures the variation in time between each beat of your heart, with a higher score generally indicating better physical fitness.
次要结局
- App Survey(Single collection time point at 1 year post-operative.)