Reproductive Health Survivorship Care Plan Pilot

Breast Cancer Clinical Trial

Official title:

Intervening on Reproductive Health in Young Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176083
• Other study ID #: SCP-1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Estrogen Deprivation Symptoms
• Hot Flashes
• Vaginal Dryness

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