NCT02176083

Reproductive Health Survivorship Care Plan Pilot

Intervening on Reproductive Health in Young Breast Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Hot Flashes
• Vaginal Dryness
• Estrogen Deprivation Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Text message management prompts

Timeline

• Start date: 2014-03-20
• Primary completion: 2014-08-31
• Completion: 2015-12-31
• First posted: 2014-06-26
• Last updated: 2020-04-20
• Results posted: 2020-04-20

Locations

2 sites across 1 country: United States