Pre-operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Endometrial Serous Adenocarcinoma
- Sponsor
- NRG Oncology
- Enrollment
- 190
- Locations
- 393
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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. TERTIARY OBJECTIVES : I. To evaluate whether the preoperative GA-GYN scores obtained before and after neoadjuvant chemotherapy will be associated with major postoperative complications in elderly patients undergoing open interval cytoreduction surgery. II. To describe reasons why surgeons at centers where open cytoreduction surgery is the standard of care choose to perform interval surgery vs primary surgery, and to explore the association of the preoperative GA-GYN score with the decision to perform primary surgery or interval surgery or no surgery. III. To collect the following specific information on how elderly women with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma are treated at centers that consider open cytoreduction surgery the standard of care: (1) the percentage of patients treated with primary open cytoreduction vs. interval open cytoreduction vs. no surgery and (2) to ascertain the extent of cytoreduction. IV. To determine whether neoadjuvant chemotherapy will be associated with changes in the GA-GYN score to change by comparing the GA-GYN scores obtained before and after neoadjuvant chemotherapy. V. To determine whether 30-day readmission rates after cytoreductive surgery correlate with the GA-GYN score. OUTLINE: At time of consent and within 14 days of surgery, patients complete a pre-operative geriatric assessment that evaluates functional status, comorbid medical conditions, psychological state, social support, and nutritional status. Post-operative complications are also collected for 6 weeks after surgery or until the date patients initiate or restart chemotherapy whichever is first.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
Time Frame: 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
Time Frame: Up to 6 weeks after surgery
Secondary Outcomes
- 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)