Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer

Official Title

Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy With Pelvic Lymphadenectomy) for Stage IA1 (LVSI+) and IA2-IB1 (≤ 2CM) Cervical Cancer

Summary:

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.

Trial Description

Primary Outcome:

• 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)
• 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
• Lymphedema
• Maximum grade and duration of severe adverse events associated with bladder, bowel, and sexual dysfunction and lymphedema

Secondary Outcome:

• Maximum grade of treatment-related adverse events
• Change in overall quality of life
• Change in cancer worries based on Impact of Events score
• Change in reproductive concerns based on reproductive concerns (14 items) score
• Site of first recurrence
• Recurrence-free survival
• Overall survival

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.

View this trial on ClinicalTrials.gov