- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00735514
Compliance to Vaginal Dilation Therapy in Patients Who Have Undergone Radiation Therapy For Stage IB, Stage IIA, Stage IIB, Stage IIIA, or Stage IIIB Cervical Cancer or Stage IA, Stage IB, Stage IIA, or Stage IIB Endometrial Cancer
Adherence to Vaginal Dilation Following Pelvic Radiotherapy for Gynecological Cancers
RATIONALE: Understanding how well patients comply with their treatment regimen may help doctors determine best treatment and ongoing care for future patients.
PURPOSE: This phase I study is looking at compliance with vaginal dilation therapy in women who have undergone radiation therapy for stage IB, stage IIA, stage IIB, stage IIIA, or stage IIIB cervical cancer or stage IA, stage IB, stage IIA, or stage IIB endometrial cancer.
Study Overview
Status
Detailed Description
OBJECTIVES:
Primary
- To determine adherence to vaginal dilation therapy after radiotherapy in patients with early-stage IB grade 2-IIIB cervical cancer or stage IA grade 3-IIB endometrial cancer.
- To identify demographic, medical, and psychosocial factors associated with adherence to recommendations for vaginal dilation in these patients.
- To describe the sexual, marital, and non-marital dyadic functioning of these patients.
OUTLINE: Patients from the IMPAC registry in Radiation Oncology at the University Hospitals Case Medical Center, Ireland Cancer Center complete questionnaires online or by mail. Questionnaires include the Vaginal Dilation Adherence questionnaire, the Sexual Function-Vaginal Changes Questionnaire, the Dyadic Satisfaction questionnaire, and the Physician/Nurse Recommendation of Vaginal Dilation questionnaire.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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Cleveland, Ohio, United States, 44024
- Geauga Regional Hospital
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Cleveland, Ohio, United States, 44060
- Lake/University Ireland Cancer Center
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Cleveland, Ohio, United States, 44121
- University Suburban Health Center
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Cleveland, Ohio, United States, 44122
- UHHS Chagrin Highlands Medical Center
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Cleveland, Ohio, United States, 44130
- Southwest General Health Center
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Cleveland, Ohio, United States, 44145
- UHHS Westlake Medical Center
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Cleveland, Ohio, United States, 44708
- Mercy Cancer Center at Mercy Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
- History of early-stage IB grade 2-IIIB cervical cancer or stage IA grade 3-IIB endometrial cancer
Meets the following criteria:
- Received radiotherapy for this disease
- Treated within the last 3 years and followed for at least 6 months
PATIENT CHARACTERISTICS:
- Able to read and understand English
- Currently with or without a sexual partner
- No history of other cancers
- No other potentially life-threatening disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adherence to vaginal dilation therapy after radiotherapy as measured by the Vaginal Dilation Adherence questionnaire
Time Frame: one time questionaire
|
one time questionaire
|
Demographic, medical, & psychosocial factors assoc. with adherence to vaginal dilation by Vaginal Dilation Adherence questionnaire, Sexual Function-Vaginal Changes Questionnaire, & Physician/Nurse Recommendation of Vaginal Dilation questionnaire
Time Frame: one time questionaire
|
one time questionaire
|
Sexual, marital, and non-marital dyadic functioning as measured by the Sexual Function-Vaginal Changes Questionnaire and the Dyadic Satisfaction questionnaire
Time Frame: one time questionaire
|
one time questionaire
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE5808 (OTHER: Case Comprehensive Cancer Center)
- P30CA043703 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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