Clinical trial NCT00735514: 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
Official title: Adherence to Vaginal Dilation Following Pelvic Radiotherapy for Gynecological Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-08-15
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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.

Eligibility 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

Primary outcomes:
measure: Adherence to vaginal dilation therapy after radiotherapy as measured by the Vaginal Dilation Adherence questionnaire
timeFrame: one time questionaire
measure: 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
timeFrame: one time questionaire
measure: Sexual, marital, and non-marital dyadic functioning as measured by the Sexual Function-Vaginal Changes Questionnaire and the Dyadic Satisfaction questionnaire
timeFrame: one time questionaire
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Geauga Regional Hospital
state: Ohio
city: Cleveland
country: United States
facility: Lake/University Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: University Suburban Health Center
state: Ohio
city: Cleveland
country: United States
facility: UHHS Chagrin Highlands Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Southwest General Health Center
state: Ohio
city: Cleveland
country: United States
facility: UHHS Westlake Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Mercy Cancer Center at Mercy Medical Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Lois C. Friedman, PhD
role: PRINCIPAL_INVESTIGATOR
References: