Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy

Trial ID or NCT#

NCT02058550

Status

not recruiting iconNOT RECRUITING

Purpose

This randomized, pilot phase I trial studies whether phone or email reminders increases vaginal dilator use in patients with endometrial, cervical, or vaginal cancers after they undergo brachytherapy. Brachytherapy is a type of internal radiation which uses radioactive material placed directly into or near a tumor to kill tumor cells. A reminder program may help increase use of vaginal dilators and decrease long-term side effects following brachytherapy.

Official Title

Phase I Pilot Study Evaluating Vaginal Dilator Use and Toxicity Following Vaginal Brachytherapy

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Patients with gynecologic cancer who are undergoing vaginal brachytherapy as part of their treatment - Patients cannot have previously received pelvic external beam radiation or brachytherapy. Patients may be enrolled while undergoing vaginal brachytherapy radiation treatment. - Patients should have a life expectancy of at least 1 year - No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status requirements - No organ and marrow function requirements - Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
  1. - Patients who have received prior pelvic external beam radiation or brachytherapy will be excluded - No restrictions regarding use of other investigational agents - No exclusion requirements due to co-morbid disease or intercurrent illness - No investigational agent, so no exclusion requirements regarding history of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent or device - No exclusion criteria relating to concomitant medications - No exclusion criteria for pregnant or nursing patients from participating in this study (Of note, pregnant patients will not be treated with vaginal brachytherapy, a requirement for enrolling on this study)
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Investigator(s)

Elizabeth Kidd
Elizabeth Kidd
Radiation oncologist
Associate Professor of Radiation Oncology (Radiation Therapy)

Contact us to find out if this trial is right for you.

Contact

Dylann Fujimoto
650-723-8843

View on ClinicalTrials.gov