NCT02315469

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

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

Primary Purpose
Intervention/Treatment
    • Type: OTHER
    • Name: Comprehensive Geriatric Assessment
    • Description: Complete pre-operative geriatric assessment
    • Arm Group Labels: Observational (geriatric assessment)
    • Type: OTHER
    • Name: Questionnaire Administration
    • Description: Ancillary studies
    • Arm Group Labels: Observational (geriatric assessment)
Sponsor
  • NRG Oncology