This clinical trial studies the physical function and quality-of-life before and after surgery in patients with stage I cervical cancer. Studying quality-of-life in patients undergoing surgery for cervical cancer may help determine the intermediate-term and long-term effects of surgery.
PRIMARY OBJECTIVES: I. To examine the changes before and after non-radical surgical treatment (simple hysterectomy or cone biopsy \[fertility preservation\] and pelvic lymphadenectomy) on functional outcomes of bladder, bowel, and sexual function for stage IA1 (lymphatic vessel invasion positive \[LVSI+\]) and IA2-IB1 (=\< 2 cm) carcinoma of the cervix. II. To evaluate incidence and severity of lymphedema after non-radical surgery (simple hysterectomy or cone biopsy \[fertility preservation\] and pelvic lymphadenectomy) for stage IA1 (LVSI+) and IA2-IB1 (=\< 2 cm) carcinoma of the cervix. SECONDARY OBJECTIVES: I. To investigate if non-radical surgery (simple hysterectomy or cone biopsy \[fertility preservation\] with pelvic lymphadenectomy) demonstrates greater physical function and less toxicity in comparison to historical data on radical surgery (radical hysterectomy or radical trachelectomy). II. To evaluate incidence and severity of treatment-related adverse events, including surgical complications, among the entire cohort and by treatment type. III. To evaluate changes in quality of life (QOL) (Functional Assessment of Cancer Therapy-Cervix \[FACT-Cx\]), cancer worries (Impact of Events Scale \[IES\]) and sexual (Female Sexual Function Index \[FSFI\])/reproductive concerns (RCS) among the entire cohort and by treatment type. IV. To explore relationships (correlation, interaction, independence) between functional outcomes (i.e., bladder function, bowel function, sexual function), adverse events (including and surgical complication lymphedema \[Gynecologic Cancer Lymphedema Questionnaire (GCLQ)\]), cancer worry (IES), surgical complications, and overall quality of life (FACT-Cx). V. To determine participants' intention for conception \& fertility rates (Integrative Care for Fertility \[ICF\]) and assess the reproductive concerns (RCS) of women following cone biopsy and pelvic lymphadenectomy for stage IA1 (LVSI+) and IA2-IB1 (=\< 2 cm) carcinoma of the cervix. VI. To estimate the efficacy of non-radical surgery (simple hysterectomy or cone biopsy \[fertility preservation\] and pelvic lymphadenectomy) for stage IA1 (LVSI+) and IA2-IB1 (=\< 2 cm) carcinoma of the cervix. OUTLINE: Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy. Patients complete the FACT-Cx, the IES, the FSFI, the GCLQ, and the Patient Reported Outcomes Measurement Information System (PROMIS) questionnaires at baseline, 4-6 weeks after surgery, and then every 6 months for 3 years. Patients undergoing cone biopsy and pelvic lymphadenectomy also complete the ICF and RCS questionnaires. After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 1 year, and then every 6 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
224
Undergo cone biopsy
Ancillary studies
Ancillary studies
Undergo hysterectomy
Undergo lymphadenectomy
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 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
Berkeley, California, United States
Change in bladder and bowel function score based on supplemental bladder and bowel questions plus 4 items from the Functional Assessment of Cancer Therapy-Cervix (3 bladder and 1 bowel question)
Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
Time frame: Baseline to 3 years
Change in sexual function and activity based on Female Sexual Function Index (19 items) score plus 2 Patient Reported Outcomes Measurement Information System screener items
Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
Time frame: Baseline to 3 years
Lymphedema
Based on Cancer Lymphedema Questionnaire score.
Time frame: Up to 3 years
Maximum grade and duration of severe adverse events associated with bladder, bowel, and sexual dysfunction and lymphedema
Graded according to Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 will be used staring April 1, 2018).
Time frame: Up to 3 years after non-radical surgical procedure
Maximum grade of treatment-related adverse events
Graded according to Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 will be used staring April 1, 2018).
Time frame: Up to 30 days after surgical procedure
Change in overall quality of life
Will be assessed based on Functional Assessment of Cancer Therapy-Cervix (15 items) score. Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
Time frame: Baseline to 3 years
Change in cancer worries based on Impact of Events score
Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
Time frame: Baseline to 3 years
Change in reproductive concerns based on reproductive concerns (14 items) score
Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
Time frame: Baseline to 3 years
Site of first recurrence
Classified as either local (pelvis regions, including vaginal) or distant (abdomen, lung, bone, brain, and other).
Time frame: Up to 3 years
Recurrence-free survival
Product-limit estimates according to the method of Kaplan and Meier will be used to estimate recurrence-free survival. In addition, Cox proportional hazard regression will be employed to evaluate relative risk (hazard ratio) adjusting for known prognostic factors. Trellis plots will be used to display point estimates of hazard ratio and respective 95% confidence intervals from subgroup analyses. Local recurrence will be summarized using frequency tables and plot of cumulative incidence of local recurrence over time.
Time frame: Up to 3 years
Overall survival
Product-limit estimates according to the method of Kaplan and Meier will be used to estimate overall survival. In addition, cox proportional hazard regression will be employed to evaluate relative risk (hazard ratio) adjusting for known prognostic factors. Trellis plots will be used to display point estimates of hazard ratio and respective 95% confidence intervals from subgroup analyses. Gompertz hazard regression will also be employed to evaluate relative risk (hazard ratio) and cure rates, adjusting for known prognostics factors.
Time frame: Up to 3 years
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