Design of a randomized controlled trial on the efficacy of a reproductive health survivorship care plan in young breast cancer survivors Journal Article


Authors: Stark, S. S.; Natarajan, L.; Chingos, D.; Ehren, J.; Gorman, J. R.; Krychman, M.; Kwan, B.; Mao, J. J.; Myers, E.; Walpole, T.; Pierce, J. P.; Su, H. I.
Article Title: Design of a randomized controlled trial on the efficacy of a reproductive health survivorship care plan in young breast cancer survivors
Abstract: Background: Young breast cancer survivors (YBCS) have unmet needs for managing hot flashes, fertility-related concerns, sexual health, and contraception. Purpose: Describe the design and participant characteristics of a randomized controlled trial testing the efficacy of the survivorship care plan on reproductive health (SCP-R) intervention on improving hot flashes, fertility-related concerns, sexual health, and contraception in YBCS. Methods: SCP-R is a web-based intervention with text message support encompassing evidence- based practices on four reproductive health issues. YBCS with ≥1 reproductive health issue are randomized to intervention (full SCP-R access) or attention control (access to list of online resources) arms with 24-week follow-up. The primary outcome will be improvement of at least one reproductive health issue measured by validated self-report instruments. Each YBCS nominated one healthcare provider (HCP), who can access the same materials as their patient. HCP outcomes are preparedness and confidence in discussing each issue. Results: Among 318 YBCS screened, 57.2% underwent randomization. Mean age was 40.0 (SD 5.9), and mean age at cancer diagnosis was 35.6 (SD 5.4). Significant hot flashes, fertility-related concerns, vaginal symptoms, and inadequate contraception were reported by 50.5%, 50%, 46.7%, 62.1% of YBCS, respectively; 70.9% had multiple issues. Among 165 nominated HCPs, 32.7% enrolled. The majority of HCPs reported preparedness (68.5–90.7%) and confidence (50.0–74.1%) in discussing reproductive health issues with YBCS. HCPs were least likely to report preparedness or confidence in discussing fertility-related concerns. Conclusion: Conducting a trial for improving YBCS reproductive health online is feasible, providing a mechanism to disseminate evidence-based management. © 2018
Keywords: breast cancer; randomized controlled trial; fertility; hot flashes; survivorship care plan; contraception
Journal Title: Contemporary Clinical Trials
Volume: 77
ISSN: 1551-7144
Publisher: Elsevier Inc.  
Date Published: 2019-02-01
Start Page: 27
End Page: 36
Language: English
DOI: 10.1016/j.cct.2018.12.002
PROVIDER: scopus
PUBMED: 30553078
PMCID: PMC6754982
DOI/URL:
Notes: Contemp. Clin. Trials -- Export Date: 2 January 2019 -- Article -- Source: Scopus
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  1. Jun J Mao
    243 Mao