Ma Chunxuan, Adler Rachel H, Neidre Daria B, Chen Ronald C, Northouse Laurel L, Rini Christine, Tan Xianming, Song Lixin
School of Nursing, University of Texas Health Science Center, San Antonio, TX, United States.
University of Kansas Medical Center, Kansas City, KS, United States.
J Med Internet Res. 2024 Dec 3;26:e51877. doi: 10.2196/51877.
Family-based randomized controlled trials (RCTs) encounter recruitment and retention challenges. Cancer-focused RCTs typically recruit convenience samples from local cancer centers and hospitals.
This study aimed to examine the recruitment and retention of a population-based, patient-partner dyad cohort in an RCT testing a dyadic eHealth intervention to improve the quality of life in patients with prostate cancer and their partners.
In this 2-arm, parallel-group RCT, men who recently completed treatment for localized prostate cancer statewide were recruited through North Carolina Central Cancer Registry rapid case ascertainment between April 2018 and April 2021, coinciding with the COVID-19 pandemic. Patient-partner dyads underwent baseline assessments and were randomly assigned to either the intervention or control groups. Follow-up surveys were conducted at 4, 8, and 12 months after baseline. Descriptive and logistic regression analyses were used to achieve the study's aims.
Of the 3078 patients referred from rapid case ascertainment, 2899 were screened. A total of 357 partners were approached after obtaining the eligible patients' permission, 280 dyads completed baseline assessments and were randomized (dyad enrollment rate: 85.11%, 95% CI 81.3%-88.9%), and 221 dyads completed the 12-month follow-up (retention rate: 78.93%, 95% CI 74.2%-83.7%). Regarding the factors associated with retention, compared with White participants, people self-reporting as "other races" (including American Indian, Asian, and multiracial) were more likely to drop out of the study (odds ratio 2.78, 95% CI 1.10-7.04), and older participants were less likely to withdraw (odds ratio 0.96, 95% CI 0.92-0.99).
Despite the negative impact of the pandemic, we successfully recruited enough patient-partner dyads to test our RCT hypotheses. Our recruitment and retention rates were equivalent to or higher than those in most dyadic intervention studies. A well-functioning research team and specific strategies (eg, eHealth intervention, internet phone, and online surveys) facilitated the recruitment and retention of patients with prostate cancer and their partners during the unprecedented pandemic.
ClinicalTrials.gov NCT03489057; https://clinicaltrials.gov/study/NCT03489057.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-https://doi.org/10.1186/s13063-021-05948-5.
基于家庭的随机对照试验（RCT）面临招募和留住参与者的挑战。以癌症为重点的RCT通常从当地癌症中心和医院招募便利样本。
本研究旨在检验一项基于人群的患者-伴侣二元队列在RCT中的招募和留存情况，该RCT测试一种二元电子健康干预措施，以改善前列腺癌患者及其伴侣的生活质量。
在这项双臂平行组RCT中，2018年4月至2021年4月期间，与新冠疫情同时，通过北卡罗来纳州中央癌症登记处的快速病例确定，招募了全州范围内最近完成局限性前列腺癌治疗的男性。患者-伴侣二元组接受基线评估，并被随机分配到干预组或对照组。在基线后4、8和12个月进行随访调查。使用描述性和逻辑回归分析来实现研究目的。
在快速病例确定转诊的3078名患者中，2899名接受了筛查。在获得符合条件患者的许可后，共接触了357名伴侣，280个二元组完成了基线评估并被随机分组（二元组入组率：85.11%，95%CI 81.3%-88.9%），221个二元组完成了12个月的随访（留存率：78.93%，95%CI 74.2%-83.7%）。关于与留存相关的因素，与白人参与者相比，自我报告为“其他种族”（包括美洲印第安人、亚洲人和多种族）的人更有可能退出研究（比值比2.78，95%CI 1.10-7.04），而年龄较大的参与者退出的可能性较小（比值比0.96，95%CI 0.92-0.99）。
尽管疫情产生了负面影响，但我们成功招募了足够的患者-伴侣二元组来检验我们的RCT假设。我们的招募和留存率等于或高于大多数二元干预研究中的比率。一个运作良好的研究团队和特定策略（如电子健康干预、网络电话和在线调查）在前所未有的疫情期间促进了前列腺癌患者及其伴侣的招募和留存。
ClinicalTrials.gov NCT03489057；https://clinicaltrials.gov/study/NCT03489057。
国际注册报告标识符（IRRID）：RR2-https://doi.org/10.1186/s13063-021-05948-5。
