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Reproductive Health Survivorship Care Plan Pilot

This study has been completed.
Information provided by (Responsible Party):
Hui-Chun Irene Su, University of California, San Diego Identifier:
First received: June 20, 2014
Last updated: December 2, 2015
Last verified: December 2015
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.

Condition Intervention
Breast Cancer
Hot Flashes
Vaginal Dryness
Estrogen Deprivation Symptoms
Behavioral: Text message management prompts

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Intervening on Reproductive Health in Young Breast Cancer Survivors

Resource links provided by NLM:

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Hot flash response rate [ Time Frame: 4 weeks ]
    Rate of reporting daily hot flashes

Secondary Outcome Measures:
  • Hot flash frequency [ Time Frame: 1 week ]
    Average hot flash frequency over 4th week on study

  • Hot flash severity [ Time Frame: 1 week ]
    Average hot flash severity over 4th week of study

  • Change in hot flash frequency and severity [ Time Frame: 4 weeks ]
  • Vaginal dryness [ Time Frame: 4 weeks ]
    Vaginal dryness at the end of study; change in vaginal dryness between baseline and end of study

  • Female Sexual Function Index (FSFI) [ Time Frame: 4 weeks ]
    FSFI score in 4th week; change in FSFI score between baseline and 4th week

  • Anxiety [ Time Frame: 4 weeks ]
  • Depression [ Time Frame: 4 weeks ]

  • Participant satisfaction and burden from text messages [ Time Frame: 4 weeks ]

Other Outcome Measures:
  • Menopause-specific quality of life (MENQOL) [ Time Frame: 4 weeks ]
    MENQOL score in 4th week; change in MENQOL scores between base and 4th week

Enrollment: 40
Study Start Date: March 2014
Study Completion Date: December 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Text message management prompts: YBCS will receive text message prompts on how to manage hot flashes and vaginal dryness
Behavioral: Text message management prompts
No Intervention: Control
Control YBCS will not receive text message prompts on managing hot flashes and vaginal dryness


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Breast cancer
  • Female
  • Completed primary breast cancer treatment
  • Age <=45
  Contacts and Locations
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Please refer to this study by its identifier: NCT02176083

United States, California
UC San Diego
La Jolla, California, United States, 92093-0901
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Irene Su, MD MSCE UC San Diego
  More Information

Responsible Party: Hui-Chun Irene Su, Assistant Professor of Reproductive Medicine, University of California, San Diego Identifier: NCT02176083     History of Changes
Other Study ID Numbers: SCP-1
Study First Received: June 20, 2014
Last Updated: December 2, 2015

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Breast Diseases
Skin Diseases
Signs and Symptoms processed this record on April 28, 2017