Clinical trial · Interventional
Health Interventions in Men Undergoing Radical Prostatectomy
Health Interventions in Men Undergoing Radical Prostatectomy- A Randomized Controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding could not be secured
Summary
Brief summary (as posted)
The goal of the study is to assess the impact of a health intervention, involving both diet and exercise modification, on outcomes following radical prostatectomy for the treatment of clinically localized prostate cancer. The specific urological outcomes expected to be improved are accelerated and/or improved recovery of erectile function (EF), as well as urinary continence, both very commonly affected by this surgery. Furthermore, as demonstrated by changes in responses to various questionnaires, an improvement in overall health-related quality of life is expected. Finally, an improvement in patients participating in the intervention groups in physical parameters, including body mass index (BMI), blood pressure (BP), and metabolic parameters, including serum glucose and cholesterol levels, is expected.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction Following Radical Prostatectomy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensive Fitness Intervention | Behavioral | — | UNRESOLVED |
| TRIMM | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- NO_INTERVENTION
- label
- Local Control Group
- description
- This arm is for patients in the District of Columbia (DC), (Maryland) MD, (Virginia) VA area that are able to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to standard recommendations for fitness/health interventions prior to surgery.
- type
- EXPERIMENTAL
- label
- Local TRIMM Group
- description
- This arm is for patients in the DC, MD, VA area that are able to attend all follow up visits at 3 month, 6 month, 12 month and 18 months post operative periods that have been randomized to receive daily text message reminder and prompts targeted to the patient's dietary, fitness and urologic goals and needs using the Tailored Rapid Interactive Mobile Messaging (TRIMM) method. Patients will receive these text messages from 4 weeks prior to surgery until 8 week after surgery
- interventionNames
- Behavioral: TRIMM
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * men 40-65 years of age * localized prostate cancer (clinical stage \< T2b, Gleason grade \< 7, pre-operative prostate specific antigen (PSA) \< 10) * scheduled to undergo curative nerve-sparing prostatectomy at the Johns Hopkins Hospital Exclusion Criteria: * in a stable relationship for at least 6 months * moderately to severely impaired preoperative erectile function (IIEF-erectile function domain score \< 16) * answering less than 2-3 times or \> to question #6 on the IIEF * severe lower urinary tract symptoms International Prostate Symptom Score (IPSS) \>20
References
Publications (0)
Data not yet available