This clinical trial studies lymphedema after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer. Collecting information over time about how often lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer, cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan the best treatment.
PRIMARY OBJECTIVES: I. To prospectively estimate the incidence of lower extremity lymphedema in patients undergoing radical surgery with a concurrent lymphadenectomy with a concurrent lymphadenectomy for a gynecologic malignancy. II. To identify risk factors for the development of lower extremity lymphedema following radical surgery among patients with any one of the three types of gynecologic malignancy studied and to develop a corresponding predictive model. SECONDARY OBJECTIVES: I. To identify the effect that lower extremity lymphedema has on quality of life (QOL) (as measured with Functional Assessment of Cancer Therapy - General \[FACT-G\] + disease specific subscale), psychological adjustment (as measured with Impact of Events Scale \[IES\] and Functional Assessment of Chronic Illness Therapy \[FACIT\] body image items) and physical disability (of lower extremity as measured with Lower Extremity Functional Scale \[LEFS\]) and physical function(as measured by FACT-Functional Wellbeing \[FW\] subscale, FACIT disease specific items \& patient-reported outcomes measurement information system \[PROMIS\] items) and to investigate potential protective mechanisms (FACT-Social Wellbeing \[SW\] subscale and patient characteristics). II. To explore if patient self-reported symptoms (as measured with the lymphedema \[LE\] Symptom Measure \[Cancer Lymphedema Questionnaire (GCLQ)\]) are associated with the development of lymphedema in patients undergoing radical surgery for gynecologic malignancy. TERTIARY OBJECTIVES: I. To explore the effect of moderate or severe lymphedema (primary endpoint) on QOL outcomes, as measured by the FACT-General (G) questionnaire. OUTLINE: Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to accrual as of June 9, 2014) Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open route. Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy +/- para-aortic node sampling. Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,055
Ancillary studies
Ancillary studies
Undergo lymphedema assessment
Undergo surgery
Undergo surgery
Undergo lymphadenectomy
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Incidence of lymphedema, assessed through volumetric measurements using serial circumferential measurements performed from 10 cm above the heel to the inguinal crease at 10 cm intervals
A competing risks analysis will be required to estimate the cumulative incidence of lymphedema. Transition probabilities in the Markov Chain will be estimated by simple proportions, ignoring covariates, to address this primary objective. Confidence intervals for the cumulative incidence of lymphedema then will be computed using the Delta Method, utilizing the fact that the transition proportions have and asymptotic multivariate normal distribution.
Time frame: Up to 24 months
Risk factors for the development of lower extremity lymphoma in patients with endometrial cancers
If risk factors are identified, a model will be developed to predict the level of risk (low, moderate, high) of lymphedema following gynecologic cancer treatment overall, and following treatment for endometrial cancer specifically. The predictive power of the models for these rates will be assessed.
Time frame: Up to 24 months
Patient self-reported symptoms
Whether the patient self-reported symptoms are associated with the development of lymphedema wit be explored.
Time frame: Up to 24 months
Quality of life
As measured by the FACT QOL scale, psychological adjustment as measured by the Impact of Events Subscale (IES), and FACIT body image items, physical disability as measured by the Lower Extremity Functional Scale -(LEFS) and PROs of physical health status/function (sexual), as measured by FACT-FW; FACIT \& PROMIS.
Time frame: Up to 24 months
Risk factors for the development of lower extremity lymphoma in patients with cervical cancers
If risk factors are identified, a model will be developed to predict the level of risk (low, moderate, high) of lymphedema following gynecologic cancer treatment overall, and following treatment for endometrial cancer specifically. The predictive power of the models for these rates will be assessed.
Time frame: Up to 24 months
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University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus
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...and 203 more locations