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Efficacy of a web-based women’s health survivorship care plan for young breast cancer survivors: a randomized controlled trial

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Abstract

Purpose

Breast cancer survivorship care plans (SCP) have limited content addressing women’s health issues. This trial tested if young breast cancer survivors who receive a web-based, women’s health SCP were more likely to improve on at least one of the four targeted issues (hot flashes, fertility-related concerns, contraception, and vaginal symptoms) compared to attention controls.

Methods

A randomized controlled trial recruited female survivors ages 18–45 at diagnosis, 18–50 at enrollment, completed primary cancer treatment, and had a significant women’s health issue: moderate or higher fertility-related concerns; ≥ 4 hot flashes/day with ≥ 1 of moderate severity; ≥ 1 moderate vaginal atrophy symptoms; or not contracepting/using less effective methods. Survivors underwent stratified, block randomization with equal allocation to intervention and control groups. The intervention group accessed the online SCP; controls accessed curated resource lists. In intention-to-treat analysis, the primary outcome of improvement in at least one issue by 24 weeks was compared by group.

Results

182 participants (86 intervention, 96 control), mean age 40.0 ± 5.9 and 4.4 ± 3.2 years since diagnosis, were randomized. 61 intervention group participants (70.9%) improved, compared to 55 controls (57.3%) (OR 1.82, 95% CI 0.99–3.4, p = 0.057). The following issue-specific improvements were observed in the intervention versus control arms: fertility-related concerns (27.9% vs. 14.6%, OR 2.3, 95% CI 1.1–4.8); hot flashes (58.5% vs. 55.8%, OR 1.1, 95% CI 0.57–2.2); vaginal symptoms (42.5% vs. 40.7%, OR 1.1, 95% CI 0.6–2.0); contraception (50% vs. 42.6%, OR 1.4, 95% CI 0.74–2.5).

Conclusions

In young breast cancer survivors, a novel, web-based SCP did not result in more change in the primary outcome of improvement in at least one of the four targeted women’s health issues, than the attention control condition. The intervention was associated with improved infertility concerns, supporting efficacy of disseminating accessible, evidence-based women’s health information to this population.

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Acknowledgements

This study was conducted in collaboration with Young Survival Coalition, Susan B. Komen Foundation—San Diego, Army of Women.

Funding

This work was supported by the California Breast Cancer Research Program 20OB-0144; National Cancer Institute P30-CA008748.

Author information

Authors and Affiliations

  1. Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, San Diego, USA

    H. Irene Su

  2. Moores Cancer Center, University of California San Diego, 3855 Health Sciences Drive, Dept. 0901, La Jolla, San Diego, CA, 92093-0901, USA

    H. Irene Su, Shaylyn Stark, Brian Kwan, Sarah Boles, John P. Pierce & Loki Natarajan

  3. Department of Family and Preventive Medicine, University of California San Diego, San Diego, USA

    Brian Kwan, John P. Pierce & Loki Natarajan

  4. Department of Medicine, University of California San Diego, San Diego, USA

    Sarah Boles

  5. Young Survival Coalition, New York, USA

    Diana Chingos

  6. Department of Chemical and Biomolecular Engineering, University of Notre Dame, Notre Dame, USA

    Jennifer Ehren

  7. School of Social and Behavioral Health Sciences, Oregon State University College of Public Health and Human Sciences, Corvalis, USA

    Jessica R. Gorman

  8. Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, USA

    Michael Krychman

  9. Bendheim Integrative Medicine Center, Memorial Sloan Kettering Cancer Center, New York, USA

    Sally A. D. Romero & Jun J. Mao

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  1. H. Irene Su
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Corresponding author

Correspondence to H. Irene Su.

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Ethical approval

The clinical trial complies with the current laws of the United States. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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All authors declare that they have no conflict of interest.

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Irene Su, H., Stark, S., Kwan, B. et al. Efficacy of a web-based women’s health survivorship care plan for young breast cancer survivors: a randomized controlled trial. Breast Cancer Res Treat 176, 579–589 (2019). https://doi.org/10.1007/s10549-019-05260-6

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