Overview

This trial is active, not recruiting.

Conditions endometrial serous adenocarcinoma, fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma, stage iiia uterine corpus cancer, stage iiib uterine corpus cancer, stage iiic uterine corpus cancer, stage iva uterine corpus cancer, stage ivb uterine corpus cancer
Treatments comprehensive geriatric assessment, questionnaire administration
Sponsor NRG Oncology
Collaborator National Cancer Institute (NCI)
Start date February 2015
End date December 2016
Trial size 228 participants
Trial identifier NCT02315469, GOG-ELD1301, NCI-2014-01376, NRG-CC002, U10CA101165, UG1CA189867

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
comprehensive geriatric assessment
Complete pre-operative geriatric assessment
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
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
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

Measure
Comorbidity, as measured by the Older American Resources and Services (OARS) Physical Health section
time frame: Up to 14 days before surgery
Extent of residual disease in patients undergoing open primary cytoreduction surgery
time frame: 6 weeks after surgery
Functional status, as measured by Activities of Daily Living (ADL)
time frame: Up to 14 days before surgery
Functional status, as measured by Instrumental Activities of Daily Living (IADL)
time frame: Up to 14 days before surgery
Number of falls in last 6 months
time frame: Up to 14 days before surgery
Nutritional status, as measured by BMI
time frame: Up to 14 days before surgery
Nutritional status, as measured by percentage unintentional weight loss in last 6 months
time frame: Up to 14 days before surgery
Patient's overall functioning, as measured by the physician rated performance rating scale
time frame: Up to 14 days before surgery
Patient's overall functioning, as measured by the self-reported performance rating scale
time frame: 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
time frame: Up to 14 days before surgery
Social functioning, as measured by the Medical Outcomes Study (MOS) Social Activity Limitations Measure
time frame: Up to 14 days before surgery
Social support, as measured by the MOS Social Support Survey
time frame: Up to 14 days before surgery

Eligibility Criteria

Female participants at least 70 years old.

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

Additional Information

Official title Pre-operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers
Principal investigator Amina Ahmed
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by NRG Oncology.