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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-05-31

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.

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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.

Conditions

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Cervical Cancer Endometrial Cancer Radiation Toxicity Sexuality and Reproductive Issues

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No