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



Status:Recruiting
Conditions:Breast Cancer, Cervical Cancer, Cervical Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:5/12/2018
Start Date:October 1, 2012

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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

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.

Inclusion Criteria:

- Patient must consent for the appropriate surgery

- Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or
adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion
[LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any grade

- All patients must have undergone a cone biopsy or loop electrosurgical excision
procedure (LEEP); depth of invasion must be =< 10 mm

- Patients must have no evidence of metastasis on positron emission tomography (PET)
scan or magnetic resonance imaging (MRI) or computed tomography (CT) scan of the
pelvis and chest imaging

- Patients who have met the pre-entry requirements

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information

- Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

Exclusion Criteria:

- Patients with stage IA1 disease who are LVSI negative

- Patients with stage IB1 with tumor size (maximum visible or palpable) > 2 cm

- Patients with >= stage IB2 disease

- Patients with clear cell or neuroendocrine cell types

- Patients with depth of invasion > 10 mm on first cone biopsy (or LEEP)

- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last five years; patients are also excluded if their previous
cancer treatment contraindicates this protocol therapy
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1700 Coffee Rd
Modesto, California 95355
(209) 526-4500
Principal Investigator: John K. Chan
Phone: 877-827-3222
Memorial Medical Center Memorial is affiliated with Sutter Health, a family of not-for-profit hospitals, physician...
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from
Modesto, CA
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Morgantown, West Virginia 26505
Principal Investigator: Jamie L. Lesnock
Phone: 304-598-6560
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from
Morgantown, WV
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1 Good Samaritan Way
Mount Vernon, Illinois 62864
(618) 242-4600
Good Samaritan Regional Health Center St. Mary's Good Samaritan, Incorporated (SMGSI) was created in 1996...
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mi
from
Mount Vernon, IL
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1330 Coshocton Ave
Mount Vernon, Ohio 43050
(740) 393-9000
Principal Investigator: Timothy D. Moore
Phone: 740-393-9000
Knox Community Hospital A community-owned, 115-bed, not-for-profit hospital located in Mount Vernon, Ohio (approximately 40...
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mi
from
Mount Vernon, OH
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Mountain View, California 94040
Principal Investigator: John K. Chan
Phone: 877-827-3222
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from
Mountain View, CA
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Mountain View, California 94040
Principal Investigator: John K. Chan
Phone: 877-827-3222
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from
Mountain View, CA
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Mukwonago, Wisconsin 53149
Principal Investigator: Janet G. Turner
Phone: 262-928-7632
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Mukwonago, WI
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501 Hospital Rd
New Richmond, Wisconsin 54017
(715) 243-2800
Principal Investigator: Joseph W. Leach
Phone: 952-993-1517
Cancer Center of Western Wisconsin For community members who need effective and compassionate cancer care,...
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mi
from
New Richmond, WI
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1324 5th St N
New Ulm, Minnesota 56073
(507) 217-5000
Principal Investigator: Joseph W. Leach
Phone: 952-993-1517
New Ulm Medical Center New Ulm Medical Center is a nonprofit hospital and clinic serving...
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mi
from
New Ulm, MN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Mario M. Leitao
Phone: 212-639-7202
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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from
New York, NY
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