NCT03916796终止不适用
Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percentage of prescribed dietary and physical therapy visits completed during the cancer rehabilitation protocol
研究概览
简要总结
This is a pilot study with a feasibility lead-in evaluating the use of multimodal cancer rehabilitation in patients planning to undergo radiotherapy and surgical resection for extremity or superficial trunk soft tissue sarcoma (STS). At enrollment, patients will be assigned to either a pre-operative radiation or post-operative radiation cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed soft tissue sarcoma of the extremity, or superficial trunk (abdomen or chest)
- •Planning to receive radiotherapy and surgical resection
- •At least 16 years of age.
- •ECOG performance status ≤ 3
- •Able to complete the cancer rehabilitation protocol safely, as determined by a treating physician.
- •Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
排除标准
- •Patients deemed ineligible for curative therapy by the treating medical oncologist, radiation oncologist, or surgeon.
- •Patients with deep retroperitoneal or abdominal STS
- •Patients who have received prior radiotherapy and, based on the treating radiation oncologist's opinion, may not safely be treated with protocol neoadjuvant radiotherapy.
- •Currently receiving any investigational agents.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- •Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test prior to starting radiotherapy.
- •HIV-positive patients whose CD4+ T-cell count is < 350 cells/mcL.
- •Receiving concurrent chemoradiation therapy
结局指标
主要结局
Percentage of prescribed dietary and physical therapy visits completed during the cancer rehabilitation protocol
时间窗: Through 3 month follow-up
* This will be quantified as the proportion of prescribed visits within the prehabilitation protocol that are attended by the patient. If a patient participates in any portion of a prescribed visit, it will be counted as attended. * Physical therapy visits are optional from 6 months-24 months
次要结局
- Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy(From baseline through 24 month follow-up)
- Quality of life as measured by the PROMIS Global total score(Change from baseline through 24 month follow-up)
- Patient fall risk as measured by Timed Up and Go test(Change from baseline through 3 month follow-up)
- Acute wound complication rate(Within first 90 days following surgery)
- Patient general physical health status as measured hand grip strength(Change from baseline through 3 month follow-up)
- Quality of life as measured by the Work Ability Index(Change from baseline through 24 month follow-up)
- Quality of life as measured by the history of previous falls(Change from baseline through 24 month follow-up)
- Quality of life as measured by the TESS(Change from baseline through 24 month follow-up)
- Patient cardiovascular capacity as measured by the 6-minute walk test(Change from baseline through 3 month follow-up)
- Patient general physical health status as measured by 30-second sit to stand test(Change from baseline through 3 month follow-up)
研究者
研究点 (2)
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