Abstract：
OBJECTIVE: Adjuvant endocrine therapy (AET) reduces recurrence risk after hormone receptor-positive breast cancer, but non-adherence is common. We pilot-tested SOIE, a program to enhance AET experience and adherence, to assess its acceptability, feasibility, and effects on psychosocial precursors of AET adherence.
METHODS: We conducted a 12-month pilot randomized controlled trial among women who had a first AET prescription. Intervention group received SOIE while control group received usual care. Psychosocial factors from the Theory of Planned Behavior (TPB) (intention - primary outcome -, attitude, subjective norm, behavioral control), additional constructs (AET knowledge, social support, coping planning), impact of AET services received, and adherence were measured by questionnaires at baseline, 3-month, and 12-month endpoints. Group patterns were compared using repeated measures analyses with generalized estimating equations.
RESULTS: A total of 106 women were randomized (participation = 54.9%; intervention n = 52; control n = 54; retention = 93.8%). Among SOIE women, ≥ 90% received the program components and were satisfied. Both groups scored high on adherence intentions and group patterns over time were not statistically different. In the intervention group, AET knowledge and coping planning with side effects increased (group-by-time p-value = .002 and .016), a higher proportion reported that AET services received helped them take their AET (p < .05) and have a consistent daily intake (p = .01).
CONCLUSIONS: SOIE is feasible and acceptable for survivors with an AET. SOIE did not significantly impact adherence intentions but was beneficial for other program outcomes and daily intake.
CONCLUSIONS: SOIE may represent an encouraging avenue to enhance supportive care and empower survivors with managing AET.
METHODS: We conducted a 12-month pilot randomized controlled trial among women who had a first AET prescription. Intervention group received SOIE while control group received usual care. Psychosocial factors from the Theory of Planned Behavior (TPB) (intention - primary outcome -, attitude, subjective norm, behavioral control), additional constructs (AET knowledge, social support, coping planning), impact of AET services received, and adherence were measured by questionnaires at baseline, 3-month, and 12-month endpoints. Group patterns were compared using repeated measures analyses with generalized estimating equations.
RESULTS: A total of 106 women were randomized (participation = 54.9%; intervention n = 52; control n = 54; retention = 93.8%). Among SOIE women, ≥ 90% received the program components and were satisfied. Both groups scored high on adherence intentions and group patterns over time were not statistically different. In the intervention group, AET knowledge and coping planning with side effects increased (group-by-time p-value = .002 and .016), a higher proportion reported that AET services received helped them take their AET (p < .05) and have a consistent daily intake (p = .01).
CONCLUSIONS: SOIE is feasible and acceptable for survivors with an AET. SOIE did not significantly impact adherence intentions but was beneficial for other program outcomes and daily intake.
CONCLUSIONS: SOIE may represent an encouraging avenue to enhance supportive care and empower survivors with managing AET.
摘要：
目的：辅助内分泌治疗（AET）降低激素受体阳性乳腺癌术后复发风险，但不坚持是常见的。我们对SOIE进行了试点测试,提高AET经验和依从性的计划，为了评估其可接受性，可行性,以及对AET坚持的心理社会前兆的影响。
方法：我们在首次服用AET处方的女性中进行了为期12个月的随机对照试验。干预组接受SOIE治疗，对照组接受常规护理。来自计划行为理论(TPB)的社会心理因素(意图-主要结果-，态度,主观规范，行为控制)，附加结构(AET知识，社会支持,应对计划)，收到的AET服务的影响，和依从性是通过基线问卷测量的，3个月,和12个月的终点。使用重复测量分析和广义估计方程比较了群体模式。
结果：共有106名女性被随机分组（参与=54.9%；干预n=52；对照组n=54；保留率=93.8%）。在SOIE女性中,≥90%收到程序组件并感到满意。两组在坚持意向方面得分较高，并且随着时间的推移，组模式没有统计学差异。在干预组中，AET知识和副作用的应对计划增加（按时间分组的p值=.002和.016），较高比例的人报告说，接受AET服务帮助他们服用AET（p<.05），并且每日摄入量一致（p=.01）。
结论：SOIE对于AET幸存者是可行和可接受的。SOIE没有显着影响坚持意图，但对其他计划结果和每日摄入量有益。
结论：SOIE可能代表了一种令人鼓舞的途径，可以加强支持性护理并授权幸存者管理AET。
方法：我们在首次服用AET处方的女性中进行了为期12个月的随机对照试验。干预组接受SOIE治疗，对照组接受常规护理。来自计划行为理论(TPB)的社会心理因素(意图-主要结果-，态度,主观规范，行为控制)，附加结构(AET知识，社会支持,应对计划)，收到的AET服务的影响，和依从性是通过基线问卷测量的，3个月,和12个月的终点。使用重复测量分析和广义估计方程比较了群体模式。
结果：共有106名女性被随机分组（参与=54.9%；干预n=52；对照组n=54；保留率=93.8%）。在SOIE女性中,≥90%收到程序组件并感到满意。两组在坚持意向方面得分较高，并且随着时间的推移，组模式没有统计学差异。在干预组中，AET知识和副作用的应对计划增加（按时间分组的p值=.002和.016），较高比例的人报告说，接受AET服务帮助他们服用AET（p<.05），并且每日摄入量一致（p=.01）。
结论：SOIE对于AET幸存者是可行和可接受的。SOIE没有显着影响坚持意图，但对其他计划结果和每日摄入量有益。
结论：SOIE可能代表了一种令人鼓舞的途径，可以加强支持性护理并授权幸存者管理AET。
