Clinical trial · Interventional
Improving Decision-Making for Low Health Literate Prostate CA Patients
NCT05800483CI-TRIAL-00065312completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Healium | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Healium
- description
- Healium is a web-based platform that employs a user-centric design and aims to appeal to a low health literate population. It features a simple language and layout, a large font size, contrasting text and background colors, bright color palette, and use of short labels and headings to describe content.
- interventionNames
- Behavioral: Healium
- type
- NO_INTERVENTION
- label
- Comparison (Healing Choices)
- description
- The Healing Choices program represents a virtual health center that patients visit to obtain disease and treatment-related information. The software was designed to be open to exploration with an intuitive layout, without restrictions in terms of order of access. Information is stored in virtual rooms, such as a library, a conference room showing videos by survivors who discuss their approach to treatment, and physician offices containing videos of physicians representing different treatment specialties. All information was extensively vetted by health education experts of the National Cancer Institute's Cancer Information Services (CIS).
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * a diagnosis of localized prostate cancer and eligible for all treatment options (ie., surgery, radiation, active surveillance); * had not yet made a treatment decision or begun treatment; and * have basic proficiency (grade school level) in reading English. Exclusion Criteria: • none
References
Publications (1)
- DERIVEDDiefenbach MA, Marziliano A, Tagai EK, Pfister H, Lapitan E, Hall SJ, Vira M, Ibrahim S, Aibel K, Kutikov A, Horwitz EM, Miyamoto C, Reese AC, Miller SM. Preference Elicitation and Treatment Decision-Making Among Men Diagnosed With Prostate Cancer: Randomized Controlled Trial Results of Healium. J Med Internet Res. 2023 Oct 20;25:e46552. doi: 10.2196/46552. PMID 37862103