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Reproductive Health Survivorship Care Plan (SCPR)

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ClinicalTrials.gov Identifier: NCT02667626
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Hui-Chun Irene Su, University of California, San Diego

Brief Summary:

The investigators propose to test the efficacy of the Reproductive Health Survivorship Care Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young breast cancer survivors (YBCS). Most YBCS 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 such as hot flashes, fertility concerns, limited contraception options and sexual problems. Together they have a major, negative impact on quality of life.

Despite substantial research, treatment guidelines and clinical expertise on these issues, most YBCS and their healthcare providers have limited guidance on how best to manage these reproductive health late effects. The research team has generated a practical, accessible, evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their providers to address this deficit in survivorship care. This clinical trial will test if YBCS who receive the web-based SCP-R are more likely than controls to improve on at least one of these reproductive health issues: hot flashes, sexual health, fertility concerns, and contraception.


Condition or disease Intervention/treatment Phase
Breast Cancer Hot Flashes Sexual Dysfunction Fertility Contraception Other: Reproductive Health Survivorship Care Plan (SCPR) Other: Control Phase 3

Detailed Description:

Participants may be recruited from throughout the United States, as all study activities may be done remotely. It is not necessary to live in San Diego or visit UC San Diego to participate in the study.

YBCS who are interested in the study will be provided access to an online screening survey to determine eligibility. Eligible YBCS who consent to the study will be followed for 24 weeks.

Following a one-week study run in, YBCS participants will be randomized to the SCPR intervention or control arms and receive the corresponding interventions.

All YBCS participants will complete 3 study time points at enrollment, 12 and 24 weeks. At each time point, they will complete a web-based study questionnaire on medical and reproductive health. YBCS participants will also daily track their hot flashes via text messaging. YBCS participants will designate a healthcare provider with whom they would discuss reproductive health issues.

Designated healthcare providers will be approached to participate in the study. Those providers who enroll will complete 2 study assessments at weeks 0 and 24. At each study time point, HCP will be assessed for preparedness on managing reproductive health issues by a web-based questionnaire.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervening on Reproductive Health in Young Breast Cancer Survivors
Study Start Date : November 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : January 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: SCPR Intervention

Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.

Healthcare providers of young breast cancer participants randomized to the intervention arm will receive their patient's SCPR and access to the same additional web-based educational reproductive health information as their patient, including resource lists of helpful websites.

Other: Reproductive Health Survivorship Care Plan (SCPR)
The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.

Active Comparator: Control

Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.

Healthcare providers of young breast cancer participants randomized to the waitlist control arm will receive access to the same web-based resources as their patient.

Other: Control
Web-based resource lists and text-based study adherence reminders




Primary Outcome Measures :
  1. Hot flash score [ Time Frame: 24 weeks ]
    Change in hot flash score

  2. Fertility concerns subscale of the Reproductive Concerns After Cancer Scale [ Time Frame: 24 weeks ]
    Change in fertility concerns subscale score

  3. Use of WHO Class I or II contraception [ Time Frame: 24 weeks ]
    Proportion using WHO Class I or II contraceptive methods

  4. Vaginal Atrophy Symptoms Scale [ Time Frame: 24 weeks ]
    Change in score


Secondary Outcome Measures :
  1. Healthcare provider preparedness scale [ Time Frame: 24 weeks ]
    Change in score


Other Outcome Measures:
  1. Depression (PHQ-8) [ Time Frame: 12 and 24 weeks ]
    Change in score

  2. Social support (MOS Social Support) [ Time Frame: 12 and 24 weeks ]
    Change in score

  3. Insomnia scale [ Time Frame: 12 and 24 weeks ]
    Change in score

  4. Female sexual function inventory [ Time Frame: 12 and 24 weeks ]
    Change in score

  5. Confidence for managing reproductive health issues scale [ Time Frame: 12 and 24 weeks ]
    Change in score

  6. Menopause quality of life (MENQOL) [ Time Frame: 12 and 24 weeks ]
    Change in score



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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:

  • Breast cancer (Stages 0-III) diagnosis
  • Breast cancer diagnosis age ≤ 45 years
  • ≤ 5 years since breast cancer diagnosis
  • Current age 18 to 50 years
  • Completed treatment with surgery, radiation and chemotherapy (if applicable)
  • Able to read English
  • Able to consent to the study
  • Access to an Internet connection

Exclusion:

• Women who are pregnant at recruitment


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): NCT02667626


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

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Responsible Party: Hui-Chun Irene Su, Associate Professor of Reproductive Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02667626     History of Changes
Other Study ID Numbers: 140863
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Interested investigators may apply for deidentified data from this study

Keywords provided by Hui-Chun Irene Su, University of California, San Diego:
Breast cancer survivor
Cancer survivorship
Survivorship care plan
Vaginal dryness
Vulvovaginal atrophy
Vasomotor symptom
Infertility
Family planning

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