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NCT02315469

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

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-10

Study Completion Date

2019-02-09

Brief Summary

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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

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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

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (geriatric assessment)

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.

Comprehensive Geriatric Assessment

Intervention Type OTHER

Complete pre-operative geriatric assessment

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Comprehensive Geriatric Assessment

Complete pre-operative geriatric assessment

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amina Ahmed

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Site Status

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Site Status

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Site Status

John Muir Medical Center-Concord Campus

Concord, California, United States

Site Status

Kaiser Permanente-Fremont

Fremont, California, United States

Site Status

Kaiser Permanente-Fresno

Fresno, California, United States

Site Status

Kaiser Permanente-Irvine

Irvine, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Kaiser Permanente-Modesto

Modesto, California, United States

Site Status

Kaiser Permanente-Oakland

Oakland, California, United States

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Kaiser Permanente-Redwood City

Redwood City, California, United States

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Kaiser Permanente-Richmond

Richmond, California, United States

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Kaiser Permanente-Roseville

Roseville, California, United States

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Kaiser Permanente-South Sacramento

Sacramento, California, United States

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Kaiser Permanente - Sacramento

Sacramento, California, United States

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Kaiser Permanente-San Francisco

San Francisco, California, United States

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Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

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Kaiser Permanente San Leandro

San Leandro, California, United States

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Kaiser Permanente-San Rafael

San Rafael, California, United States

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Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

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Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

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Kaiser Permanente-South San Francisco

South San Francisco, California, United States

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Kaiser Permanente-Stockton

Stockton, California, United States

Site Status

Olive View-University of California Los Angeles Medical Center

Sylmar, California, United States

Site Status

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Site Status

Kaiser Permanente-Vallejo

Vallejo, California, United States

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Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

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John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

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Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

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The Medical Center of Aurora

Aurora, Colorado, United States

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University of Colorado Hospital

Aurora, Colorado, United States

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Boulder Community Hospital

Boulder, Colorado, United States

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Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

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Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status