Reproductive Health Survivorship Care Plan Pilot

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hui-Chun Irene Su, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02176083
First received: June 20, 2014
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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 (Subject)
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 ] [ Designated as safety issue: No ]
    Rate of reporting daily hot flashes


Secondary Outcome Measures:
  • Hot flash frequency [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Average hot flash frequency over 4th week on study

  • Hot flash severity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Average hot flash severity over 4th week of study

  • Change in hot flash frequency and severity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Vaginal dryness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    FSFI score in 4th week; change in FSFI score between baseline and 4th week

  • Anxiety [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    PHQ8

  • Participant satisfaction and burden from text messages [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Menopause-specific quality of life (MENQOL) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    MENQOL score in 4th week; change in MENQOL scores between base and 4th week


Estimated Enrollment: 38
Study Start Date: April 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer
  • Female
  • Completed primary breast cancer treatment
  • Age <=45
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02176083

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

No publications provided

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
Study First Received: June 20, 2014
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014