Back to resultsReproductive Health Survivorship Care Plan Pilot
Primary Purpose
Breast Cancer, Hot Flashes, Vaginal Dryness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text message management prompts
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Breast cancer
- Female
- Completed primary breast cancer treatment
- Age <=45
Sites / Locations
- UC San Diego
- UCSD Moores Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness
Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
Outcomes
Primary Outcome Measures
Hot Flash Frequency
Median number of daily hot flashes over 4th week of study
Secondary Outcome Measures
Full Information
NCT ID
NCT02176083
First Posted
June 20, 2014
Last Updated
April 9, 2020
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT02176083
Brief Title
Reproductive Health Survivorship Care Plan Pilot
Official Title
Intervening on Reproductive Health in Young Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2014 (undefined)
Primary Completion Date
August 31, 2014 (Actual)
Study Completion Date
December 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hot Flashes, Vaginal Dryness, Estrogen Deprivation Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness
Intervention Type
Behavioral
Intervention Name(s)
Text message management prompts
Primary Outcome Measure Information:
Title
Hot Flash Frequency
Description
Median number of daily hot flashes over 4th week of study
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Breast cancer
Female
Completed primary breast cancer treatment
Age <=45
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Su, MD MSCE
Organizational Affiliation
UC San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0901
Country
United States
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reproductive Health Survivorship Care Plan Pilot
We'll reach out to this number within 24 hrs