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

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00735514

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

10.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Endometrial Cancer Radiation Toxicity Sexuality and Reproductive Issues	Behavioral: compliance monitoring Other: questionnaire administration Procedure: assessment of therapy complications Procedure: management of therapy complications Procedure: psychosocial assessment and care

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 Design

Study Type:

Observational

Actual Enrollment :

83 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Adherence to Vaginal Dilation Following Pelvic Radiotherapy for Gynecological Cancers

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

May 1, 2010

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geauga Regional Hospital	Cleveland	Ohio	United States	44024
2	Lake/University Ireland Cancer Center	Cleveland	Ohio	United States	44060
3	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
4	University Suburban Health Center	Cleveland	Ohio	United States	44121
5	UHHS Chagrin Highlands Medical Center	Cleveland	Ohio	United States	44122
6	Southwest General Health Center	Cleveland	Ohio	United States	44130
7	UHHS Westlake Medical Center	Cleveland	Ohio	United States	44145
8	Mercy Cancer Center at Mercy Medical Center	Cleveland	Ohio	United States	44708