Median number of daily hot flashes over 4th week of study
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 2.2 | 1.2 – 3.6 |
| Control | 1.4 | 0.7 – 2.3 |
Last reviewed · How we verify
Reproductive Health Survivorship Care Plan Pilot
NA trial testing Text message management prompts in Breast Cancer in 38 participants. Completed in 31 December 2015.
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 20 March 2014 |
| Primary completion | 31 August 2014 |
| Estimated completion | 31 December 2015 |
| Sites | 2 locations across United States |
University of California, San Diego
Adults 18 to 45, female only, with Breast Cancer or Hot Flashes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median number of daily hot flashes over 4th week of study
| Group | Value | 95% CI |
|---|---|---|
| Intervention | 2.2 | 1.2 – 3.6 |
| Control | 1.4 | 0.7 – 2.3 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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