Breast Cancer Clinical Trial
Official title:
Intervening on Reproductive Health in Young Breast Cancer Survivors
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 |
Verified date | April 2020 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | UC San Diego | La Jolla | California |
United States | UCSD Moores Cancer Center | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
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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