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Clinical Trials/NCT02176083
NCT02176083
Completed
Not Applicable

Intervening on Reproductive Health in Young Breast Cancer Survivors

University of California, San Diego2 sites in 1 country38 target enrollmentMarch 20, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of California, San Diego
Enrollment
38
Locations
2
Primary Endpoint
Hot Flash Frequency
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this pilot study is to test the feasibility of a 4-week text message based intervention on hot flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the intervention (text messages on hot flash and vaginal dryness management) and control arms. All participants will be prompted to provide daily hot flash frequency and severity via text messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash severity and vagina dryness between the intervention and control arms.

Registry
clinicaltrials.gov
Start Date
March 20, 2014
End Date
December 31, 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hui-Chun Irene Su

Assistant Professor of Reproductive Medicine

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • Breast cancer
  • Completed primary breast cancer treatment
  • Age \<=45

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Hot Flash Frequency

Time Frame: 1 week

Median number of daily hot flashes over 4th week of study

Study Sites (2)

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