JMIR Publications

ABSTRACT

Background:

Family-based randomized controlled trials (RCT) face challenges in recruitment and retention. Most cancer-focused RCTs recruit convenience samples from local cancer centers and hospitals.

Objective:

In this study, we examined the recruitment and retention of a population-based patient-partner dyad cohort for an RCT, testing the efficacy of a dyadic eHealth intervention to improve the quality of life in patients with prostate cancer (PCa) and their partners.

Methods:

In this two-arm, parallel groups RCT, men who recently completed treatment for localized PCa from across the state were recruited from the North Carolina Central Cancer Registry Rapid Case Ascertainment (RCA) between April 2018 to April 2021. Notably, recruitment coincided with the COVID-19 pandemic. After baseline assessments, we randomly assigned patient-partner dyads to the intervention or control group. Dyads completed follow-up surveys 4-, 8-, and 12 months post-baseline. Data were analyzed using descriptive analyses.

Results:

Of the 3,078 patients referred from RCA, 2,899 were contacted for screening; 357 partners were approached after obtaining interested and eligible patients’ permission; 280 dyads completed baseline assessments and randomized (dyad enrollment rate: 85.11%); and 221 dyads completed the 12-month follow-up (retention rate: 78.93%).

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 (e.g., eHealth intervention, Internet phone, and online surveys) facilitated recruitment and retention in this dyadic RCT with PCa patients and their partners during the unprecedented pandemic. Clinical Trial: CT.gov NCT03489057