Pre-operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NRG Oncology
- 入组人数
- 190
- 试验地点
- 393
- 主要终点
- GA-GYN score, defined as the summation of the risk score for each risk factor derived from the predictive model including 5 risk factors from the GA and 3 other risk factors
研究概览
简要总结
This research trial studies comprehensive patient questionnaires in predicting complications in older patients with gynecologic cancer undergoing surgery. Comprehensive patient questionnaires completed before surgery may help identify complications, such as the need for assistance in taking medications, decreased mobility, decreased social activity, and falls, and may improve outcomes for older patients with gynecologic cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether the preoperative geriatric assessment (GA)-gynecology (GYN) score will be associated with major post-operative complications in elderly patients undergoing open primary cytoreduction surgery.
SECONDARY OBJECTIVES:
I. To explore associations between individual variables of the preoperative geriatric assessment and major post-operative complications in patients undergoing open primary cytoreduction surgery.
II. To assess the association between the preoperative GA-GYN score and cytoreducibility defined by extent of residual disease in patients undergoing open primary cytoreduction surgery.
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
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma irrespective of performance status; this clinical determination is made by the treating physician
- •Patients must have signed an approved informed consent and authorization permitting release of personal health information
- •Patients who can understand sufficiently to be able to respond to questions posed by the study instruments
- •Patients and/or caregiver (durable power of attorney) can give consent and caregiver can assist with the responses to questionnaire
- •NOTE: it is the intent of this trial that all patients 70 years or older presenting to the participating physician/center be offered enrollment onto this study; eligible patients may enroll and subsequently receive neoadjuvant chemotherapy followed by interval surgery, primary cytoreductive surgery or no surgery at all
- •Post-operative pathology will not exclude patients from this study
排除标准
- •Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
- •Patients who would have planned surgery performed by the minimally invasive technique; institutions which perform cytoreductive surgery via the minimally invasive technique should not participate in this study; the minimally invasive surgery (MIS) technique is also not considered standard technique for primary cytoreductive surgery for advanced stage ovarian, fallopian tube or peritoneal cancers
- •Patients who receive chemotherapy treatment (for a gynecologic malignancy) prior to consideration of enrollment into this trial and taking the geriatric assessment will be excluded
- •Patients who have a known pre-operative primary uterine cancer, confirmed by endometrial biopsy
结局指标
主要结局
GA-GYN score, defined as the summation of the risk score for each risk factor derived from the predictive model including 5 risk factors from the GA and 3 other risk factors
时间窗: Up to 14 days before surgery
Geriatric assessment variables are used in the predictive model; the risk factors will be used to derive the total score.
Occurrence of major post-operative complications outlined in The American College of Surgeons' National Surgical Quality Improvement Program
时间窗: Up to 6 weeks after surgery
次要结局
- Social support, as measured by the MOS Social Support Survey(Up to 14 days before surgery)
- Patient's overall functioning, as measured by the self-reported performance rating scale(Up to 14 days before surgery)
- Psychological status, as measured by the Mental Health Inventory (MHI) that is based upon the General Well-Being Scale(Up to 14 days before surgery)
- Social functioning, as measured by the Medical Outcomes Study (MOS) Social Activity Limitations Measure(Up to 14 days before surgery)
- Extent of residual disease in patients undergoing open primary cytoreduction surgery(6 weeks after surgery)
- Functional status, as measured by Activities of Daily Living (ADL)(Up to 14 days before surgery)
- Patient's overall functioning, as measured by the physician rated performance rating scale(Up to 14 days before surgery)
- Nutritional status, as measured by BMI(Up to 14 days before surgery)
- Functional status, as measured by Instrumental Activities of Daily Living (IADL)(Up to 14 days before surgery)
- Number of falls in last 6 months(Up to 14 days before surgery)
- Comorbidity, as measured by the Older American Resources and Services (OARS) Physical Health section(Up to 14 days before surgery)
- Nutritional status, as measured by percentage unintentional weight loss in last 6 months(Up to 14 days before surgery)