NCT Number: NCT02176083
Reproductive Health Survivorship Care Plan Pilot
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.
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
UC San Diego, La Jolla, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Breast cancer
- Female
- Completed primary breast cancer treatment
- Age <=45
Treatment and study plan
Primary outcomes
-
Hot Flash Frequency
Time frame: 1 week
Median number of daily hot flashes over 4th week of study
Sponsors and collaborators
Lead sponsor
University of California, San Diego
Other
Registry information
Official study title
Intervening on Reproductive Health in Young Breast Cancer Survivors
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2015
- First posted
- Jun 26, 2014
- Registry last updated
- Apr 20, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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