Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Aug 15, 2023
Open Peer Review Period: Aug 15, 2023 - Oct 10, 2023
Date Accepted: Aug 30, 2024
(closed for review but you can still tweet)
The Challenges and Strategies of Accrual and Retention During COVID-19 in a Randomized Controlled Trial Testing A Dyad-focused eHealth Intervention
ABSTRACT
Background:
Family-based randomized controlled trials (RCT) encounter recruitment and retention challenges. Cancer-focused RCTs typically recruit convenience samples from local cancer centers and hospitals.
Objective:
Our study examined the recruitment and retention of a population-based patient-partner dyad cohort in an RCT testing a dyadic eHealth intervention to improve quality of life in prostate cancer (PCa) patients and their partners.
Methods:
In this two-arm, parallel-group RCT, men who recently completed treatment for localized PCa statewide were recruited via the North Carolina Central Cancer Registry Rapid Case Ascertainment (RCA) between April 2018 and April 2021, coinciding with the COVID-19 pandemic. Patient-partner dyads underwent baseline assessments and were randomly assigned to the intervention or control groups. Follow-up surveys were conducted at 4-, 8-, and 12 months post-baseline. Descriptive and logistic regression analyses were employed to achieve the study’s aims.
Results:
Of the 3,078 patients referred from RCA, 2,899 were screened; 357 partners were approached after obtaining 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%). Factors associated with retention included race and age.
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 the recruitment and retention of PCa patients and their partners during the unprecedented pandemic. Clinical Trial: Clinicaltrial.gov ID: NCT03489057.
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