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NCT01915121 · ClinicalTrials.gov registry record · NA
An Educational Intervention for Patients With Bladder Cancer
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT01915121: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT01915121 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 43 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01915121, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study Summary
The study main objectives are to enhance treatment decision making and improve quality of life and post-treatment health care among patients diagnosed with invasive bladder cancer. Bladder cancer (BL Ca) is the 5th most commonly diagnosed cancer in the US . BL Ca is more common among men than women and 90% of all patients are over the age of 55. Surgery to remove the bladder followed by one of three diversion techniques (i.e., ileal conduit, continent reservoir, and neobladder) is the standard therapy following invasive bladder cancer. The emotional, functional, physical, and social impact of invasive Bl Ca treatment on patients' QOL and adjustment can be devastating. This impact significantly varies by treatment option. Treatment decision making in for BL Ca is difficult at best and potentially susceptible to a number of cognitive and affective factors (e.g., patients' emotional reaction, values, and expectations). Thus, in addition to adjusting to a potential life-threatening disease, having to cope with uncertainty about the efficacy and outcomes of different treatment options adds to the overall distress and may impair effective decision-making. In spite of increasing efforts in health communication and patient education, no study has examined treatment decision making among invasive bladder patients or has provided an educational intervention to facilitate treatment decision making among this population. To this end, and guided by the Self-Regulation theory (SRT) that emphasizes the role of cognitive and emotional factors in decision making, we have designed and pilot tested the acceptability of a preliminary educational and training experiential intervention (ETE) to address this gap in the literature. The ETE intervention uses new and innovative educational strategies and methods to educate patients about their treatment options and to facilitate their treatment decision making.
Primary Outcome
The intervention is designed to enhance treatment decision making.
Interventions
- BEHAVIORAL Nutrition Intervention
- BEHAVIORAL Education Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-06-30 |
| Phase | NA |
What the finished NCT01915121 record still lists
NCT01915121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Nutrition Intervention is the first listed.
NCT01915121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01915121 about?
NCT01915121 is a clinical study titled "An Educational Intervention for Patients With Bladder Cancer". The study main objectives are to enhance treatment decision making and improve quality of life and post-treatment health care among patients diagnosed with invasive bladder cancer. Bladder cancer (BL Ca) is the 5th most commonly diagnosed cancer in the US . BL Ca is more common among men than women...
What is the current status of trial NCT01915121?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2013-09. Estimated completion is 2017-06-30.
What interventions are being tested in trial NCT01915121?
The interventions under investigation include: Nutrition Intervention (BEHAVIORAL), Education Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01915121?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01915121's enrollment target sits among peer trials
43 1435th of 2000 higher than 565 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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