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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

Case Comprehensive Cancer Center (Case CCC) logo

Case Comprehensive Cancer Center (Case CCC)

Status

Completed

Conditions

Endometrial Cancer
Radiation Toxicity
Sexuality and Reproductive Issues
Cervical Cancer

Treatments

Procedure: assessment of therapy complications
Other: questionnaire administration
Procedure: management of therapy complications
Behavioral: compliance monitoring
Procedure: psychosocial assessment and care

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00735514
CASE5808 (Other Identifier)
P30CA043703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

83 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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