NCT02315469

Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery

Pre-operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 190 (actual)
• Sponsor: NRG Oncology · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Serous Adenocarcinoma
• Fallopian Tube Carcinoma
• Malignant Female Reproductive System Neoplasm
• Ovarian Carcinoma
• Primary Peritoneal Carcinoma
• Stage IIIA Uterine Corpus Cancer AJCC v7
• Stage IIIB Uterine Corpus Cancer AJCC v7
• Stage IIIC Uterine Corpus Cancer AJCC v7
• Stage IVA Uterine Corpus Cancer AJCC v7
• Stage IVB Uterine Corpus Cancer AJCC v7

Interventions

Type	Name	Description
OTHER	Comprehensive Geriatric Assessment	Complete pre-operative geriatric assessment
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-02-10
• Primary completion: 2016-03-15
• Completion: 2019-02-09
• First posted: 2014-12-11
• Last updated: 2021-11-24

Locations

393 sites across 2 countries: United States, Canada