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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00735514 |
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.
Condition | Intervention | Phase |
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Cervical Cancer Endometrial Cancer Radiation Toxicity Sexuality and Reproductive Issues |
Behavioral: compliance monitoring Other: questionnaire administration Procedure: assessment of therapy complications Procedure: management of therapy complications Procedure: psychosocial assessment and care Radiation: radiation therapy |
Phase I |
Study Type: | Observational |
Official Title: | Adherence to Vaginal Dilation Following Pelvic Radiotherapy for Gynecological Cancers |
Estimated Enrollment: | 81 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
Geauga Regional Hospital | Recruiting |
Cleveland, Ohio, United States, 44024 | |
Contact: Lois Friedman 216-844-1361 | |
Lake/University Ireland Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44060 | |
Contact: Lois Friedman 216-844-1361 | |
Mercy Cancer Center at Mercy Medical Center | Recruiting |
Cleveland, Ohio, United States, 44708 | |
Contact: Lois Friedman 216-844-1361 | |
University Suburban Health Center | Recruiting |
Cleveland, Ohio, United States, 44121 | |
Contact: Lois Friedman 216-844-1361 | |
UHHS Chagrin Highlands Medical Center | Recruiting |
Cleveland, Ohio, United States, 44122 | |
Contact: Lois Friedman 216-844-1361 | |
UHHS Westlake Medical Center | Recruiting |
Cleveland, Ohio, United States, 44145 | |
Contact: Lois Friedman 216-844-1361 | |
Southwest General Health Center | Recruiting |
Cleveland, Ohio, United States, 44130 | |
Contact: Lois Friedman 216-844-1361 |
Principal Investigator: | Lois C. Friedman, PhD | Case Comprehensive Cancer Center |
Responsible Party: | Case Comprehensive Cancer Center ( Lois C. Friedman ) |
Study ID Numbers: | CDR0000609896, CASE-5808 |
Study First Received: | August 14, 2008 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00735514 History of Changes |
Health Authority: | Unspecified |
radiation toxicity sexuality and reproductive issues stage I endometrial carcinoma stage II endometrial carcinoma |
stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer |
Genital Diseases, Female Endometrial Neoplasms Dilatation, Pathologic Genital Neoplasms, Female Uterine Diseases |
Uterine Neoplasms Endometrial Cancer Urogenital Neoplasms Carcinoma |
Genital Diseases, Female Neoplasms Endometrial Neoplasms Neoplasms by Site |
Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms Urogenital Neoplasms |