Abstract
BACKGROUND: Family-based randomized controlled trials (RCTs) encounter recruitment and retention challenges. Cancer-focused RCTs typically recruit convenience samples from local cancer centers and hospitals. OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT03489057; https://clinicaltrials.gov/study/NCT03489057. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-https://doi.org/10.1186/s13063-021-05948-5.