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

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), December 2008

First Received: August 14, 2008 Last Updated: May 9, 2009 History of Changes

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00735514

Purpose

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	Intervention	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 Radiation: radiation therapy	Phase I

Study Type:	Observational
Official Title:	Adherence to Vaginal Dilation Following Pelvic Radiotherapy for Gynecological Cancers

Resource links provided by NLM:

MedlinePlus related topics: Cancer Radiation Therapy

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Adherence to vaginal dilation therapy after radiotherapy as measured by the Vaginal Dilation Adherence questionnaire [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Sexual, marital, and non-marital dyadic functioning as measured by the Sexual Function-Vaginal Changes Questionnaire and the Dyadic Satisfaction questionnaire [ Designated as safety issue: No ]

Estimated Enrollment:	81
Study Start Date:	July 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735514

Locations

United States, Ohio
Case Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422
Geauga Regional Hospital	Recruiting
Cleveland, Ohio, United States, 44024
Contact: Lois Friedman 216-844-1361
Lake/University Ireland Cancer Center	Recruiting
Cleveland, Ohio, United States, 44060
Contact: Lois Friedman 216-844-1361
Mercy Cancer Center at Mercy Medical Center	Recruiting
Cleveland, Ohio, United States, 44708
Contact: Lois Friedman 216-844-1361
University Suburban Health Center	Recruiting
Cleveland, Ohio, United States, 44121
Contact: Lois Friedman 216-844-1361
UHHS Chagrin Highlands Medical Center	Recruiting
Cleveland, Ohio, United States, 44122
Contact: Lois Friedman 216-844-1361
UHHS Westlake Medical Center	Recruiting
Cleveland, Ohio, United States, 44145
Contact: Lois Friedman 216-844-1361
Southwest General Health Center	Recruiting
Cleveland, Ohio, United States, 44130
Contact: Lois Friedman 216-844-1361

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Lois C. Friedman, PhD

Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Case Comprehensive Cancer Center ( Lois C. Friedman )
Study ID Numbers:	CDR0000609896, CASE-5808
Study First Received:	August 14, 2008
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00735514 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Genital Diseases, Female
Endometrial Neoplasms
Dilatation, Pathologic
Genital Neoplasms, Female
Uterine Diseases

Uterine Neoplasms
Endometrial Cancer
Urogenital Neoplasms
Carcinoma

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Endometrial Neoplasms
Neoplasms by Site

Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on September 04, 2009