Brief Title
Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery
Official Title
Pre-operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers
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.
Study Type
Observational
Primary Outcome
Occurrence of major post-operative complications outlined in The American College of Surgeons' National Surgical Quality Improvement Program
Secondary Outcome
Extent of residual disease in patients undergoing open primary cytoreduction surgery
Condition
Endometrial Serous Adenocarcinoma
Intervention
Comprehensive Geriatric Assessment
Study Arms / Comparison Groups
Observational (geriatric assessment)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
190
Start Date
February 10, 2015
Completion Date
February 9, 2019
Primary Completion Date
March 15, 2016
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
Gender
Female
Ages
70 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Amina Ahmed, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02315469
Organization ID
NRG-CC002
Secondary IDs
NCI-2014-01376
Responsible Party
Sponsor
Study Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Amina Ahmed, Principal Investigator, NRG Oncology
Verification Date
September 2020