Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Quality of Life (QoL)
研究概览
简要总结
Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy.
详细描述
STUDY PLAN
-
Only the principal investigator, sub-investigators, and research nurse will be approaching potential participants. The above listed also will be the only consentors for the study. The recruitment process will occur during the outpatient visits being held at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. HIPAA (Health Insurance Portability and Accountability Act ) and guidelines and good clinical practice will be followed at all times to ensure that the privacy of participants included in the recruitment process are strictly guarded.
-
Patients will be registered by the Radiation Oncology clinical subjects coordinator after eligibility is confirmed and informed consent is obtained.
-
The EORTC (European Organization for Research and Treatment of Cancer)QLQ- C30 (Quality of Life Questionnaire), QLQ-CR38 (Quality of Life Questionnaire), and QLQ-CR29 (Quality of Life Questionnaire) forms will be completed by patients at the following time point:
-
Within 3 weeks prior to start of radiotherapy
-
During the 4th week of radiotherapy (when treatment-related symptoms are expected to peak)
-
Approximately one month after completion of radiotherapy during a follow-up visit
-
The QOL forms (QLC-C30, QLQ-CR38, and CR29) will be self-administered surveys. A nurse or other healthcare provider will be available to help the patient with any questions regarding the QOL forms.
-
The symptom inventory will be collected in an interview by a nurse or other healthcare provider at the following time points: d. Within 3 weeks prior to start of radiotherapy e. Once weekly during radiotherapy f. Approximately one month after completion of radiotherapy during a follow-up visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of the following questions must be answered "yes" for a patient to be eligible for this protocol.
- •Is there a working diagnosis of rectal cancer? YES NO
- •Will the patient be receiving neoadjuvant concurrent chemotherapy and pelvic radiation? YES NO
- •Is the pelvic radiation planned for a dose of 45-54 Gy and will it be delivered using a standard 3-field technique? YES NO
- •Is the patient ≥ 18 years of age? YES NO
- •Can the patient give informed consent? YES NO
排除标准
- •All of the following questions must be answered "no" for a patient to be eligible for this protocol.
- •Has there been prior radiation to the pelvis? YES NO
- •Is the patient in the "special category" designated by the Public Health Service (patients younger than 18, pregnant women, and prisoners)? YES NO
结局指标
主要结局
Quality of Life (QoL)
时间窗: 1 year
Assessment of Quality of Life of Patients post standard of care radiation therapy
次要结局
未报告次要终点