Shaylyn S Stark1, Loki Natarajan2, Diana Chingos3, Jennifer Ehren4, Jessica R Gorman5, Michael Krychman6, Brian Kwan7, Jun J Mao8, Emily Myers9, Tom Walpole10, John P Pierce11, H Irene Su12. 1. Moores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA. Electronic address: ssstark@ucsd.edu. 2. Moores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA; Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0628, USA. Electronic address: lnatarajan@ucsd.edu. 3. Patient Advocate & Representative, Young Survival Coalition, 10995 Wrightwood Lane, Studio City, CA 91604, USA. 4. Department of Chemical and Biomolecular Engineering, University of Notre Dame, 172 Fitzpatrick Hall, Notre Dame, IN 46556-5637, USA. Electronic address: jehren1@nd.edu. 5. School of Social and Behavioral Health Sciences, Oregon State University College of Public Health and Human Sciences, 160 SW 26(th) St, Corvallis, OR 97331, USA. Electronic address: jessica.gorman@oregonstate.edu. 6. Southern California Center for Sexual Health and Survivorship Medicine, 1501 Superior Ave, Suite 201, Newport Beach, CA 92663, USA. 7. Moores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA. Electronic address: bkwan@ucsd.edu. 8. Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA. Electronic address: maoj@mskcc.org. 9. Moores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA. Electronic address: eemyers@ucsd.edu. 10. Trials.ai, 4250 Executive Square Suite 200, La Jolla, CA 92037, USA. Electronic address: info@trials.ai. 11. Moores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA; Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0628, USA. Electronic address: jppierce@ucsd.edu. 12. Moores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA; Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, 9300 Campus Pointe Drive, MC 7433, La Jolla, CA 92037, USA. Electronic address: hisu@ucsd.edu.
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.
RCT Entities:
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.
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