We conducted a nationwide, randomized controlled trial to evaluate the impact of Healing Choices, a novel interactive education and treatment decision program rooted in the self-regulation theory framework, on decisional conflict and psychological distress at 2-month post-intervention in women with early-stage breast cancer. Patients were randomized to receive the National Cancer Institute’s standard print material (control) or standard print material plus Healing Choices (the intervention). The final sample at 2-month post-intervention consisted of N = 388 participants (intervention: n = 197; control: n = 191). There were no significant differences in decisional conflict or its subscales; however, psychological distress was higher in the intervention group (16.09 ± 10.25) than in the control group (14.37 ± 8.73) at follow-up, B = 1.88, 95% CI [−0.03, 3.80], t(383) = 1.94, p = .05. Upon further examination, we found that engagement with the intervention was low—41%—prompting as-treated analyses, which showed no difference in distress between users and nonusers and a positive impact of Healing Choices on decisional conflict: decisional support subscale: users (35.36 ± 15.50) versus nonusers (39.67 ± 15.99), B = −4.31 (s.e. = 2.09), p = .04. Multiple recommendations for moving ahead stem from this work: (i) intent-to-treat analyses appeared to cause distress, cautioning against interventions that may lead to information overload; (ii) engagement with the intervention is low and future work needs to focus on increasing engagement and monitoring it throughout the study; and (iii) in studies with low engagement, as-treated analyses are critical.

中文翻译：

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检查多媒体干预对早期乳腺癌患者决策冲突和心理困扰的影响：全国随机对照试验的结果

我们进行了一项全国性随机对照试验，以评估治疗选择（一种植根于自我调节理论框架的新颖的互动教育和治疗决策计划）对早期患有早发性早衰的女性干预后 2 个月的决策冲突和心理困扰的影响。一期乳腺癌。患者被随机分配接受国家癌症研究所的标准印刷材料（对照）或标准印刷材料加治疗选择（干预）。干预后 2 个月的最终样本由 N = 388 名参与者组成（干预组：n = 197；对照：n = 191）。决策冲突或其子量表没有显着差异；然而，随访时干预组的心理困扰（16.09 ± 10.25）高于对照组（14.37 ± 8.73），B = 1.88，95% CI [−0.03, 3.80]，t(383) = 1.94 ，p = .05。经过进一步检查，我们发现干预措施的参与度很低（41%），这促使我们进行了治疗分析，结果显示使用者和非使用者之间的痛苦没有差异，并且治疗选择对决策冲突有积极影响：决策支持子量表：使用者（ 35.36 ± 15.50) 与非使用者 (39.67 ± 15.99)，B = −4.31 (se = 2.09)，p = .04。这项工作提出了多项推进建议：(i) 意向治疗分析似乎会造成困扰，警告不要进行可能导致信息过载的干预措施；(ii) 对干预措施的参与度较低，未来的工作需要重点关注在整个研究过程中提高参与度并对其进行监测；(iii) 在参与度较低的研究中，治疗分析至关重要。