Reproductive Health Survivorship Care Plan Pilot
Intervening on Reproductive Health in Young Breast Cancer Survivors
1 other identifier
interventional
38
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Mar 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2014
CompletedFirst Submitted
Initial submission to the registry
June 20, 2014
CompletedFirst Posted
Study publicly available on registry
June 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2015
CompletedResults Posted
Study results publicly available
April 20, 2020
CompletedApril 20, 2020
April 1, 2020
5 months
June 20, 2014
July 18, 2019
April 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Hot Flash Frequency
Median number of daily hot flashes over 4th week of study
1 week
Study Arms (2)
Intervention
EXPERIMENTALText message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness
Control
NO INTERVENTIONControl YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
Interventions
Eligibility Criteria
You may qualify if:
- Breast cancer
- Female
- Completed primary breast cancer treatment
- Age \<=45
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UC San Diego
La Jolla, California, 92093-0901, United States
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Irene Su, MD MSCE
- Organization
- University of California, San Diego
Study Officials
- PRINCIPAL INVESTIGATOR
Irene Su, MD MSCE
UC San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Reproductive Medicine
Study Record Dates
First Submitted
June 20, 2014
First Posted
June 26, 2014
Study Start
March 20, 2014
Primary Completion
August 31, 2014
Study Completion
December 31, 2015
Last Updated
April 20, 2020
Results First Posted
April 20, 2020
Record last verified: 2020-04