Trial results for a patient empowerment program in Prostate Cancer were posted on 2026-04-03. The study indicated that early intervention significantly reduced the odds of clinically significant psychological distress, with an Odds Ratio of 3.59 (p=0.031) when comparing late to early intervention.
Background
Each year, over 20,000 men are diagnosed with prostate cancer in Canada, with most undergoing treatment options such as radical prostatectomy or radiation therapy. While effective, these procedures often lead to short- and long-term side effects, including urinary incontinence, sexual dysfunction, and reduced physical function, which can negatively impact quality of life. This study aimed to implement pre-habilitation — preventive life habits and education — to empower men and address these potential side effects, contrasting with the more common post-treatment approaches.
Trial design
This completed study, designated as Phase NA, enrolled 140 participants with Prostate Cancer. The trial investigated a patient empowerment program, comparing an "Early Intervention" arm (Arm A) with a "Late Intervention" arm (Arm B). The specific primary outcome was not listed, but the study focused on addressing quality of life issues related to prostate cancer treatment.
Key results
The trial measured the "Proportion of Participants With Clinically Significant Psychological Distress (Kessler Psychological Distress Scale-10 ≥20)". Key measurements reported were:
- In Arm A (Early Intervention), 9 participants experienced clinically significant psychological distress.
- In Arm B (Late Intervention), 14 participants experienced clinically significant psychological distress.
- Separately, for the same outcome, 57 participants in Arm A (Early Intervention) and 48 participants in Arm B (Late Intervention) were reported.
A logistic regression analysis was performed, yielding an Odds Ratio (OR) of 3.59 for clinically significant psychological distress when comparing the late intervention group to the early intervention group. This finding was statistically significant with a p-value of 0.031. The 95.0% confidence interval for this Odds Ratio ranged from 1.12 to 11.51.
What this means
The statistically significant Odds Ratio of 3.59 suggests that prostate cancer patients who receive a late intervention for patient empowerment are approximately 3.59 times more likely to experience clinically significant psychological distress compared to those receiving early intervention. This supports the trial's objective of promoting pre-habilitation and preventive life habits, indicating that proactive patient empowerment programs can play a crucial role in mitigating the psychological burden associated with prostate cancer and its treatments.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03660085, titled "Prostate Cancer - Patient Empowerment Program", were posted on 2026-04-03 on clinicaltrials.gov.