NCT01649089

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: GOG Foundation · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Squamous Cell Carcinoma
• Lymphedema
• Stage IA1 Cervical Cancer AJCC v6 and v7
• Stage IA2 Cervical Cancer AJCC v6 and v7
• Stage IB1 Cervical Cancer AJCC v6 and v7

Interventions

Type	Name	Description
PROCEDURE	Conization	Undergo cone biopsy
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo hysterectomy
PROCEDURE	Therapeutic Lymphadenectomy	Undergo lymphadenectomy

Timeline

• Start date: 2013-06-05
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2012-07-25
• Last updated: 2024-05-03

Locations

185 sites across 3 countries: United States, Canada, South Korea