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Randomized Controlled Trial
. 2019 Aug;176(3):579-589.
doi: 10.1007/s10549-019-05260-6. Epub 2019 May 3.

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

H Irene Su  1   2 , Shaylyn Stark  3 , Brian Kwan  3   4 , Sarah Boles  3   5 , Diana Chingos  6 , Jennifer Ehren  7 , Jessica R Gorman  8 , Michael Krychman  9 , Sally A D Romero  10 , Jun J Mao  10 , John P Pierce  3   4 , Loki Natarajan  3   4
Affiliations
Randomized Controlled Trial

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

H Irene Su et al. Breast Cancer Res Treat. 2019 Aug.

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.

Keywords: Breast cancer; Fertility; Randomized controlled trial; Reproductive health; Survivorship care plan.

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Conflict of interest statement

Conflicts of Interest

The authors declare that they have not conflicts of interest.

Figures

Figure 1:
Figure 1:
Consort diagram of study flow
Figure 2:
Figure 2:
At enrollment, proportions of breast cancer survivor participants (n=182) with hot flashes, fertility-related concerns, vaginal symptoms and inadequate contraception, by intervention arm.
Figure 3:
Figure 3:
By 24 weeks, proportions of breast cancer survivor participants (n=182) with improvement in their women’s health issue(s) by intervention arm, * denotes p<0.05
See this image and copyright information in PMC

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References

    1. Su HI, Sammel MD, Green J, Velders L, Stankiewicz C, Matro J, Freeman EW, Gracia CR, DeMichele A: Antimullerian hormone and inhibin B are hormone measures of ovarian function in late reproductive-aged breast cancer survivors. Cancer 2010, 116(3):592–599. - PMC - PubMed
    1. Gold EB, Flatt SW, Pierce JP, Bardwell WA, Hajek RA, Newman VA, Rock CL, Stefanick ML: Dietary factors and vasomotor symptoms in breast cancer survivors: the WHEL Study. Menopause 2006, 13(3):423–433. - PubMed
    1. Caan BJ, Emond JA, Su HI, Patterson RE, Flatt SW, Gold EB, Newman VA, Rock CL, Thomson CA, Pierce JP: Effect of postdiagnosis weight change on hot flash status among early-stage breast cancer survivors. J Clin Oncol 2012, 30(13):1492–1497. - PMC - PubMed
    1. Cvancarova M, Samuelsen SO, Magelssen H, Fossa SD: Reproduction rates after cancer treatment: experience from the Norwegian radium hospital. J Clin Oncol 2009, 27(3):334–343. - PubMed
    1. Safarinejad MR, Shafiei N, Safarinejad S: Quality of life and sexual functioning in young women with early-stage breast cancer 1 year after lumpectomy. Psychooncology 2013, 22(6):1242–1248. - PubMed

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