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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

Adherence to Vaginal Dilation Following Pelvic Radiotherapy for Gynecological Cancers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00735514
Enrollment
83
Registered
2008-08-15
Start date
2008-07-31
Completion date
2010-05-31
Last updated
2019-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

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.

OTHERquestionnaire 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.

PROCEDUREassessment 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.

PROCEDUREmanagement 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.

PROCEDUREpsychosocial 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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Adherence to vaginal dilation therapy after radiotherapy as measured by the Vaginal Dilation Adherence questionnaireone 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 questionnaireone time questionaire
Sexual, marital, and non-marital dyadic functioning as measured by the Sexual Function-Vaginal Changes Questionnaire and the Dyadic Satisfaction questionnaireone time questionaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026