Brief Title
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
Official Title
Adherence to Vaginal Dilation Following Pelvic Radiotherapy for Gynecological Cancers
Brief Summary
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.
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
Observational
Primary Outcome
Adherence to vaginal dilation therapy after radiotherapy as measured by the Vaginal Dilation Adherence questionnaire
Condition
Cervical Cancer
Intervention
compliance monitoring
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
83
Start Date
July 2008
Completion Date
May 2010
Primary Completion Date
April 2010
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lois C. Friedman, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00735514
Organization ID
CASE5808
Secondary IDs
P30CA043703
Responsible Party
Sponsor
Study Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Lois C. Friedman, PhD, Principal Investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Verification Date
October 2019