JMIR Publications

ABSTRACT

Background:

The pace of drug discovery and approvals has led to expanding treatments for cancer patients. While extensive research exists regarding barriers to enrollment on oncology clinical trials, there are limited studies evaluating processes to optimize patient education, oral anti-cancer medications administration and adherence for patients enrolled on clinical trials. In this study, we assess the feasibility of a video-based, personalized webpage for patients enrolled on genitourinary oncology clinical trials involving ≥1 oral anti-cancer medication.

Objective:

The primary objective of this trial was to assess the differences in the number of patient-initiated violations in the intervention arm compared to a control arm over four treatment cycles. Secondary objectives included patient satisfaction, frequently-asked questions by patients on the intervention arm, patient-initiated calls to study team members, and patient-reported stress levels.

Methods:

Eligible patients enrolling on a therapeutic clinical for a genitourinary malignancy were randomized 2:1 to the intervention arm or control arm. Patients randomized to the intervention arm received access to a video-based, personalized webpage, which included videos of patients’ own clinic encounters with their providers, instructional videos on medication administration and side effects, and electronic versions of educational documents.

Results:

99 patients were enrolled (89 were evaluable; 66 completed 4 cycles). 71% (n=40/56) of patients in the intervention arm had ≥1 patient-initiated violation versus 70% (n=23/33) in the control arm. There was no difference in total number of violations across four cycles between two arms (estimate=-0.0939 with 95% CI -0.6295, 0.4418, P-value=0.7313). Median baseline satisfaction scores for the intervention and control arms were 72 and 73, respectively, indicating high levels of patient satisfaction in both arms. Median baseline patient-reported stress levels were 10 and 13 for the intervention and control arms, respectively, indicating low stress levels in both arms at baseline.

Conclusions:

This study is among the first to evaluate a video-based, personalized webpage that provides patients with educational videos and video recordings of clinical trial appointments. Despite not meeting the primary endpoint of reduced patient-initiated violations, this study demonstrates the feasibility of a video-based, personalized webpage in clinical trials. Future research assessing this tool may be better suited for realms outside of clinical trials and may consider the use of an endpoint that assesses patient-reported outcomes directly. A major limitation of this study was the lack of prior data for estimating the null hypothesis in this population. Clinical Trial: The DFCI IRB determined that this randomized, phase II trial did not meet the requirements for registration to a WHO accredited trial registry as it was an ancillary, non-invasive trial.