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

NRG Oncology

Status: Completed

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

Treatments: Other: Comprehensive Geriatric Assessment; Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02315469

NRG-CC002 (Other Identifier)

GOG-ELD1301

UG1CA189867 (U.S. NIH Grant/Contract)

U10CA101165 (U.S. NIH Grant/Contract)

NCI-2014-01376 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 patients

Sex: Female

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

190 participants in 1 patient group

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.

Treatment:

Other: Questionnaire Administration

Other: Comprehensive Geriatric Assessment