Sitemba Jessica, Crisafio Mary, Li Fuzhong, Eckstrom Elizabeth, Winters-Stone Kerri M
Oregon Health & Science University.
Oregon Research Institute.
Res Sq. 2025 Feb 10:rs.3.rs-5968659. doi: 10.21203/rs.3.rs-5968659/v1.
The GET FIT trial tested fall prevention exercise approaches in older (50-75 years) post-chemotherapy, postmenopausal cancer survivors. We describe recruitment, retention, and adherence patterns from GET FIT to inform future trials.
Participants were recruited through multiple strategies (e.g., cancer and research registries, clinician referral, outreach, electronic health record (EHR) screening) and were randomized to one of three supervised, facility-based, group exercise programs for six months. We compared effectiveness of accrual across recruitment strategies, examined characteristics of women who completed the interventions to those who withdrew, and women with good (≥ 50%) versus poor (< 50%) adherence to training.
Of 1490 interested women, 442 women were eligible, randomized, and received the assigned intervention (30% accrual rate). Accrual was similar across recruitment strategies, except for EHR screening which yielded no accruals. Retention over 12 months was 87% with most dropouts occurring within the first month. There were no differences in baseline characteristics between women who did or did not drop out. Poor adherers (n = 60) had higher baseline BMI, comorbidities, pain, disability and lower physical functioning (p < 0.05) compared to more adherent women (n = 377).
A variety of recruitment strategies appear to be effective for enrolling older, postmenopausal cancer survivors into a facility-based exercise trial, except for directly approaching women identified through the EHR. Women with poorer health were at risk for study drop-out and poor adherence to exercise.
GET FIT试验在年龄较大(50 - 75岁)的化疗后、绝经后癌症幸存者中测试了预防跌倒的运动方法。我们描述GET FIT试验的招募、留存和依从模式,以为未来的试验提供参考。
通过多种策略招募参与者(如癌症和研究登记处、临床医生转诊、外展活动、电子健康记录(EHR)筛查),并将其随机分配到三个基于机构的、有监督的团体运动项目之一,为期六个月。我们比较了不同招募策略的入组效果,研究了完成干预的女性与退出者的特征,以及依从性好(≥50%)与依从性差(<50%)的训练女性的特征。
在1490名感兴趣的女性中,442名女性符合条件、被随机分组并接受了指定的干预(入组率为30%)。除EHR筛查未招募到参与者外,其他招募策略的入组情况相似。12个月的留存率为87%,大多数退出发生在第一个月内。退出和未退出的女性在基线特征上没有差异。与依从性较好的女性(n = 377)相比,依从性差的女性(n = 60)基线时的体重指数、合并症、疼痛、残疾程度更高,身体功能更低(p < 0.05)。
除了直接接触通过EHR识别出的女性外,多种招募策略似乎对将年龄较大的绝经后癌症幸存者纳入基于机构的运动试验有效。健康状况较差的女性有退出研究和运动依从性差的风险。