N/A
Completed N=38
Reproductive Health Survivorship Care Plan Pilot
Breast Cancer · Hot Flashes · Vaginal Dryness · Estrogen Deprivation Symptoms
Source: ClinicalTrials.gov NCT02176083 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Hot Flash Frequency — 2.2; 1.4 daily hot flashes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hot Flash Frequency |
2.2; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- Breast cancer
- Female
- Completed primary breast cancer treatment
- Age <=45
Data sourced from ClinicalTrials.gov (NCT02176083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.