Clinical trial · Interventional
Prostate Cancer Symptom Management for Low Literacy Men
NCT00983710CI-TRIAL-00031316completedPhase 2ClinicalTrials.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 will compare a newly-developed patient education program to help men with localized prostate cancer manage treatment-related side-effects versus usual care. The new intervention will be developed for men with lower health literacy. That means that the education materials will be developed for sixth grade reading level or lower. The materials will include lots of examples and illustrations to make it easier for people understand the information.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PC-PEP - Prostate Cancer Patient Education Program | Behavioral | — | UNRESOLVED |
| Usual care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Participants will receive a new patient education program designed to help men manage side-effects related to treatment for localized prostate cancer. The intervention will be targeted to low health literacy men.
- interventionNames
- Behavioral: PC-PEP - Prostate Cancer Patient Education Program
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Usual care, including a booklet on coping with localized prostate cancer. After the 6-month primary outcome data are collected, control group men will be offered the opportunity to cross-over and receive the new educational intervention.
- interventionNames
- Behavioral: Usual care
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male 2. 18 years or older, with biopsy-proven prostate cancer 3. Diagnosed with localized disease in the preceding 2 years 4. Have a telephone at the time of enrollment 5. Have an address where they can receive intervention materials by mail 6. Able to speak and understand English 7. Treated with radiation, surgery, or hormonal therapy 8. Receive prostate cancer treatment and follow-up at the Michael E DeBakey VA Medical Center in Houston, TX Exclusion Criteria: 1. Younger than 18 2. Female 3. Diagnosis of advanced prostate cancer 4. No treatment for prostate cancer 5. Diagnosed with localized disease more than 2 years before trial enrollment 6. Unable to speak and understand English 7. Unable to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.