Reproductive Health Survivorship Care Plan Pilot
Completed · Not applicable
Conditions studied: Breast Cancer, Hot Flashes, Vaginal Dryness, Estrogen Deprivation Symptoms
In brief
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.
Key facts
- Study ID
- NCT02176083
- Run by
- University of California, San Diego
- People needed
- 38
- Starts
- 2014-03-20
- Expected to finish
- 2015-12-31
- Last updated by the study team
- 2020-04-20
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Breast cancer
- Female
- Completed primary breast cancer treatment
- Age <=45
Where it is running
- UC San Diego — La Jolla, California, United States
- UCSD Moores Cancer Center — La Jolla, California, United States
Full record on ClinicalTrials.gov
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