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

Completed

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02315469

Run by

NRG Oncology

People needed

190

Starts

2015-02-10

Expected to finish

2019-02-09

Last updated by the study team

2021-11-24

Who can join

Age: 70 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• John Muir Medical Center-Concord Campus — Concord, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Kaiser Permanente-Fresno — Fresno, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Kaiser Permanente-Modesto — Modesto, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Kaiser Permanente-Redwood City — Redwood City, California, United States
• Kaiser Permanente-Richmond — Richmond, California, United States
• Kaiser Permanente-Roseville — Roseville, California, United States
• Kaiser Permanente-South Sacramento — Sacramento, California, United States
• Kaiser Permanente - Sacramento — Sacramento, California, United States
• Kaiser Permanente-San Francisco — San Francisco, California, United States
• Kaiser Permanente-Santa Teresa-San Jose — San Jose, California, United States
• Kaiser Permanente San Leandro — San Leandro, California, United States
• Kaiser Permanente-San Rafael — San Rafael, California, United States
• Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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