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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adherence to Vaginal Dilation Following Pelvic Radiotherapy for Gynecological Cancers

Conditions
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Cervical Cancer, Endometrial Cancer, Radiation Toxicity, Sexuality and Reproductive Issues

Intervention / Treatment
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* Behavioral: compliance monitoring
* Other: questionnaire administration
* Procedure: assessment of therapy complications
* Procedure: management of therapy complications
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: compliance monitoring|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.|
|Other: questionnaire administration|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.|
|Procedure: assessment of therapy complications|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.|
|Procedure: management of therapy complications|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.|
|Procedure: psychosocial assessment and care|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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