Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, San Diego, USA.
Moores Cancer Center, University of California San Diego, 3855 Health Sciences Drive, Dept. 0901, La Jolla, San Diego, CA, 92093-0901, USA.
Breast Cancer Res Treat. 2019 Aug;176(3):579-589. doi: 10.1007/s10549-019-05260-6. Epub 2019 May 3.
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.
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.
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).
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.
乳腺癌生存者护理计划（SCP）在解决女性健康问题方面内容有限。本试验旨在测试接受基于网络的女性健康 SCP 的年轻乳腺癌生存者在至少一个目标问题（热潮红、与生育相关的担忧、避孕和阴道症状）上是否比接受关注对照更有可能改善。
一项随机对照试验招募了诊断时年龄为 18-45 岁、入组时年龄为 18-50 岁、完成主要癌症治疗且存在重大女性健康问题的女性幸存者：中度或更高的与生育相关的担忧；≥每天 4 次热潮红，且至少有 1 次中度严重程度；≥1 种中度阴道萎缩症状；或不避孕/使用效果较差的方法。幸存者按分层、块随机分配，干预组和对照组的分配比例相等。在意向治疗分析中，通过组间比较来评估 24 周时至少一个问题改善的主要结局。
182 名参与者（86 名干预组，96 名对照组），平均年龄为 40.0±5.9 岁和 4.4±3.2 岁，随机分组。与对照组（57.3%）相比，干预组有 61 名（70.9%）参与者得到改善（OR 1.82，95%CI 0.99-3.4，p=0.057）。在干预组与对照组中观察到以下特定问题的改善：与生育相关的担忧（27.9% vs. 14.6%，OR 2.3，95%CI 1.1-4.8）；热潮红（58.5% vs. 55.8%，OR 1.1，95%CI 0.57-2.2）；阴道症状（42.5% vs. 40.7%，OR 1.1，95%CI 0.6-2.0）；避孕（50% vs. 42.6%，OR 1.4，95%CI 0.74-2.5）。
在年轻的乳腺癌幸存者中，一种新的基于网络的 SCP 并没有比关注对照组更能改善至少一个四个目标女性健康问题中的一个，这是主要的结果。该干预措施与改善不孕不育问题相关，支持向这一人群传播可及的、基于证据的女性健康信息的有效性。
