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Adherence to Vaginal Dilation Following Pelvic Radiotherapy for Gynecological Cancers


Phase 1
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Endometrial Cancer, Radiation Toxicity, Sexuality and Reproductive Issues

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Trial Information

Adherence to Vaginal Dilation Following Pelvic Radiotherapy for Gynecological Cancers


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.

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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Adherence to vaginal dilation therapy after radiotherapy as measured by the Vaginal Dilation Adherence questionnaire

Outcome Time Frame:

one time questionaire

Safety Issue:

No

Principal Investigator

Lois C. Friedman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE5808

NCT ID:

NCT00735514

Start Date:

July 2008

Completion Date:

May 2010

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Radiation Toxicity
  • Sexuality and Reproductive Issues
  • 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
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Uterine Cervical Neoplasms
  • Adenoma
  • Radiation Injuries

Name

Location
Mercy Cancer Center at Mercy Medical Center Canton, Ohio  44708
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Geauga Regional Hospital Chardon, Ohio  44024
Southwest General Health Center Middleburgh Heights, Ohio  44130
UHHS Chagrin Highlands Medical Center Orange Villager, Ohio  44122
University Suburban Health Center South Euclid, Ohio  44121
UHHS Westlake Medical Center Westlaker, Ohio  44145