Reproductive Health Survivorship Care Plan Pilot

Not Applicable

Completed

• Conditions: Vaginal Dryness; Breast Cancer; Hot Flashes; Estrogen Deprivation Symptoms
• Interventions: Behavioral: Text message management prompts

• Registration Number: NCT02176083
• Lead Sponsor: University of California, San Diego

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-20
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-26
• Primary Completion: 2014-08-31
• Study Completion: 2015-12-31
• Results First Submitted: 2019-07-18
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-09
• Last Update Submitted: 2020-04-09
• Results First Posted: 2020-04-20
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• Breast cancer
• Female
• Completed primary breast cancer treatment
• Age <=45

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Text message management prompts	Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness

Primary Outcome Measures

Name	Time	Method
Hot Flash Frequency	1 week	Median number of daily hot flashes over 4th week of study

Trial Locations

Locations (2)

UCSD Moores Cancer Center; 🇺🇸 La Jolla, California, United States

UC San Diego; 🇺🇸 La Jolla, California, United States