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Spots Global Cancer Trial Database for Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer

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Trial Identification

Brief Title: 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

Study ID: NCT01649089

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Mills-Peninsula Medical Center, Burlingame, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, United States

Eden Hospital Medical Center, Castro Valley, California, United States

Sutter Davis Hospital, Davis, California, United States

Palo Alto Medical Foundation-Fremont, Fremont, California, United States

UC San Diego Moores Cancer Center, La Jolla, California, United States

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

Memorial Medical Center, Modesto, California, United States

Palo Alto Medical Foundation-Camino Division, Mountain View, California, United States

Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

Palo Alto Medical Foundation Health Care, Palo Alto, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, United States

Sutter Roseville Medical Center, Roseville, California, United States

Sutter Medical Center Sacramento, Sacramento, California, United States

California Pacific Medical Center-Pacific Campus, San Francisco, California, United States

Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California, United States

Sutter Pacific Medical Foundation, Santa Rosa, California, United States

Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, California, United States

Olive View-University of California Los Angeles Medical Center, Sylmar, California, United States

Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, United States

Sutter Solano Medical Center/Cancer Center, Vallejo, California, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States

Jackson Memorial Hospital-Holtz Children's Hospital, Miami, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States

AdventHealth Orlando, Orlando, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, Florida, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States

Queen's Medical Center, Honolulu, Hawaii, United States

University of Hawaii Cancer Center, Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States

Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States

Sudarshan K Sharma MD Limited-Gynecologic Oncology, Hinsdale, Illinois, United States

Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States

Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States

Cancer Center of Kansas - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence, Independence, Kansas, United States

Cancer Center of Kansas-Kingman, Kingman, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Cancer Center of Kansas-Liberal, Liberal, Kansas, United States

Cancer Center of Kansas-Manhattan, Manhattan, Kansas, United States

Cancer Center of Kansas - McPherson, McPherson, Kansas, United States

Cancer Center of Kansas - Newton, Newton, Kansas, United States

Cancer Center of Kansas - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas - Salina, Salina, Kansas, United States

Cancer Center of Kansas - Wellington, Wellington, Kansas, United States

Associates In Womens Health, Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States

Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States

Cancer Center of Kansas - Wichita, Wichita, Kansas, United States

Cancer Center of Kansas - Winfield, Winfield, Kansas, United States

Baptist Health Corbin, Corbin, Kentucky, United States

Baptist Health Lexington, Lexington, Kentucky, United States

Baptist Health Madisonville/Merle Mahr Cancer Center, Madisonville, Kentucky, United States

Baptist Health Paducah, Paducah, Kentucky, United States

Hematology/Oncology Clinic PLLC, Baton Rouge, Louisiana, United States

Woman's Hospital, Baton Rouge, Louisiana, United States

Tulane University Health Sciences Center, New Orleans, Louisiana, United States

Brigham and Women's Hospital, Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Baystate Medical Center, Springfield, Massachusetts, United States

Henry Ford Hospital, Detroit, Michigan, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Mercy Hospital, Coon Rapids, Minnesota, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Unity Hospital, Fridley, Minnesota, United States

Hutchinson Area Health Care, Hutchinson, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove, Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States

Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Hennepin County Medical Center, Minneapolis, Minnesota, United States

Health Partners Inc, Minneapolis, Minnesota, United States

New Ulm Medical Center, New Ulm, Minnesota, United States

North Memorial Medical Health Center, Robbinsdale, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

United Hospital, Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center, Shakopee, Minnesota, United States

Lakeview Hospital, Stillwater, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Rice Memorial Hospital, Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States

Fairview Lakes Medical Center, Wyoming, Minnesota, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Mercy Hospital Joplin, Joplin, Missouri, United States

Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States

Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri, United States

Mercy Hospital Springfield, Springfield, Missouri, United States

CoxHealth South Hospital, Springfield, Missouri, United States

Nebraska Methodist Hospital, Omaha, Nebraska, United States

Women's Cancer Center of Nevada, Las Vegas, Nevada, United States

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Cooper Hospital University Medical Center, Camden, New Jersey, United States

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

MD Anderson Cancer Center at Cooper-Voorhees, Voorhees, New Jersey, United States

Memorial Sloan Kettering Commack, Commack, New York, United States

Memorial Sloan Kettering Westchester, Harrison, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

University of Rochester, Rochester, New York, United States

Memorial Sloan Kettering Nassau, Uniondale, New York, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Summa Health System - Akron Campus, Akron, Ohio, United States

Strecker Cancer Center-Belpre, Belpre, Ohio, United States

Aultman Health Foundation, Canton, Ohio, United States

Adena Regional Medical Center, Chillicothe, Ohio, United States

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, United States

Case Western Reserve University, Cleveland, Ohio, United States

Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Mount Carmel East Hospital, Columbus, Ohio, United States

Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

Grant Medical Center, Columbus, Ohio, United States

The Mark H Zangmeister Center, Columbus, Ohio, United States

Mount Carmel Health Center West, Columbus, Ohio, United States

Doctors Hospital, Columbus, Ohio, United States

Grandview Hospital, Dayton, Ohio, United States

Delaware Health Center-Grady Cancer Center, Delaware, Ohio, United States

Delaware Radiation Oncology, Delaware, Ohio, United States

Grady Memorial Hospital, Delaware, Ohio, United States

Dublin Methodist Hospital, Dublin, Ohio, United States

Central Ohio Breast and Endocrine Surgery, Gahanna, Ohio, United States

Mount Carmel Grove City Hospital, Grove City, Ohio, United States

Fairfield Medical Center, Lancaster, Ohio, United States

Saint Rita's Medical Center, Lima, Ohio, United States

OhioHealth Mansfield Hospital, Mansfield, Ohio, United States

Marietta Memorial Hospital, Marietta, Ohio, United States

OhioHealth Marion General Hospital, Marion, Ohio, United States

Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States

UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States

Knox Community Hospital, Mount Vernon, Ohio, United States

Licking Memorial Hospital, Newark, Ohio, United States

Newark Radiation Oncology, Newark, Ohio, United States

Mercy Health Perrysburg Cancer Center, Perrysburg, Ohio, United States

Southern Ohio Medical Center, Portsmouth, Ohio, United States

ProMedica Flower Hospital, Sylvania, Ohio, United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States

Saint Vincent Mercy Medical Center, Toledo, Ohio, United States

Mercy Health - Saint Anne Hospital, Toledo, Ohio, United States

Saint Ann's Hospital, Westerville, Ohio, United States

Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States

Jefferson Abington Hospital, Abington, Pennsylvania, United States

Paoli Memorial Hospital, Paoli, Pennsylvania, United States

Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States

Lankenau Medical Center, Wynnewood, Pennsylvania, United States

Women and Infants Hospital, Providence, Rhode Island, United States

Parkland Memorial Hospital, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

Memorial Hermann Texas Medical Center, Houston, Texas, United States

Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

Monongalia Hospital, Morgantown, West Virginia, United States

Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States

ProHealth D N Greenwald Center, Mukwonago, Wisconsin, United States

Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States

ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States

ProHealth Waukesha Memorial Hospital, Waukesha, Wisconsin, United States

UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, United States

Aurora West Allis Medical Center, West Allis, Wisconsin, United States

Odette Cancer Centre- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Samsung Medical Center, Seoul, Korea, Korea, Republic of

Catholic University of Korea-Seoul Saint Mary's Hospital, Seoul, Korea, Korea, Republic of

Seoul National University Bundang Hospital, Seongnam City, Kyeonggi-do, Korea, Republic of

Gachon University Gil Hospital, Incheon, , Korea, Republic of

Asan Medical Center, Seoul, , Korea, Republic of

Gangnam Severance Hospital, Seoul, , Korea, Republic of

Seoul National University Hospital, Seoul, , Korea, Republic of

Yonsei University Health System-Severance Hospital, Seoul, , Korea, Republic of

Kyung Hee University Hospital at Gangdong, Seoul, , Korea, Republic of

Korea Cancer Center Hospital, Seoul, , Korea, Republic of

Contact Details

Name: Allan L Covens

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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