Reproductive Health Survivorship Care Plan
Condition: Breast Cancer; Hot Flashes; Sexual Dysfunction; Fertility; Contraception
MeSH terms: Breast Neoplasms; Hot Flashes
Study type: Interventional

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.
    

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.
    

Intervention name(s): Reproductive Health Survivorship Care Plan (SCPR); Control
Intervention type(s): Other; Other
Intervention description(s): 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.; Web-based resource lists and text-based study adherence reminders
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast cancer survivor; Cancer survivorship; Survivorship care plan; Vaginal dryness; Vulvovaginal atrophy; Vasomotor symptom; Infertility; Family planning