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Contemp Clin Trials. 2019 Feb;77:27-36. doi: 10.1016/j.cct.2018.12.002. Epub 2018 Dec 12.

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

Author information

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.

KEYWORDS:

Breast cancer; Contraception; Fertility; Hot flashes; Randomized controlled trial; Survivorship care plan

PMID:
30553078
DOI:
10.1016/j.cct.2018.12.002

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