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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02176083
Other study ID # SCP-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2014
Est. completion date December 31, 2015

Study information

Verified date April 2020
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 31, 2015
Est. primary completion date August 31, 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Breast cancer

- Female

- Completed primary breast cancer treatment

- Age <=45

Study Design


Intervention

Behavioral:
Text message management prompts


Locations

Country Name City State
United States UC San Diego La Jolla California
United States UCSD Moores Cancer Center La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hot Flash Frequency Median number of daily hot flashes over 4th week of study 1 week
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