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

Completed

• Conditions: Cervical Cancer; Sexuality and Reproductive Issues; Endometrial Cancer; Radiation Toxicity

• Registration Number: NCT00735514
• Lead Sponsor: Case Comprehensive Cancer Center

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to vaginal dilation therapy after radiotherapy as measured by the Vaginal Dilation Adherence questionnaire	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	one time questionaire
Sexual, marital, and non-marital dyadic functioning as measured by the Sexual Function-Vaginal Changes Questionnaire and the Dyadic Satisfaction questionnaire	one time questionaire

Trial Locations

Locations (8)

Lake/University Ireland Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Geauga Regional Hospital; 🇺🇸 Cleveland, Ohio, United States

UHHS Chagrin Highlands Medical Center; 🇺🇸 Cleveland, Ohio, United States

University Suburban Health Center; 🇺🇸 Cleveland, Ohio, United States

Mercy Cancer Center at Mercy Medical Center; 🇺🇸 Cleveland, Ohio, United States

Southwest General Health Center; 🇺🇸 Cleveland, Ohio, United States

UHHS Westlake Medical Center; 🇺🇸 Cleveland, Ohio, United States