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Reproductive Health Survivorship Care Plan Pilot

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ClinicalTrials.gov Identifier: NCT02176083
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Hui-Chun Irene Su, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Hot Flashes Vaginal Dryness Estrogen Deprivation Symptoms Behavioral: Text message management prompts Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Intervening on Reproductive Health in Young Breast Cancer Survivors
Study Start Date : March 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2015

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U.S. FDA Resources

Arm Intervention/treatment
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



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


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

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

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

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

  6. Anxiety [ Time Frame: 4 weeks ]
  7. Depression [ Time Frame: 4 weeks ]
    PHQ8

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

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



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

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176083


Locations
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
Investigators
Principal Investigator: Irene Su, MD MSCE UC San Diego

Responsible Party: Hui-Chun Irene Su, Assistant Professor of Reproductive Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02176083     History of Changes
Other Study ID Numbers: SCP-1
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms