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NCT03149185 · ClinicalTrials.gov registry record · NA
Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer
A NA study of Prostate Cancer, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 224
- Enrollment target
- 2
- Study locations
NCT03149185 is a NA study of Prostate Cancer that has completed, run by Northwestern University. The registered enrollment target is 224 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (63% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03149185, a NA study of Prostate Cancer, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 224 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to examine the effects of various factors such as emotions, stress, stress management techniques (for example relaxation and coping techniques), and health information on quality of life, distress, depression, coping, and physical health in men diagnosed with advanced prostate cancer. The investigators also evaluate the effectiveness of a 10-week group-based internet delivered psychosocial intervention. Primary outcomes are symptom burden (e.g., urinary function, fatigue, pain) and HRQOL (e.g., general, physical \& social functioning). Participation in this study includes three face-to-face assessments: baseline (at the beginning of the research study), 6-month follow-up, and 12-month follow-up. The 6- and 12-month follow-up interviews are conducted after the participant has completed the 10-week group intervention. Participants are randomized into either an intervention group (targets stress management skills - relaxation, coping) or a control group (health information and health promotion strategies - benefits of proper nutrition and treatment compliance). Both groups meet for 10 consecutive weeks through an internet video conferencing platform. At the baseline, 6- and 12-month follow-ups, the investigators collect blood and saliva samples. The blood samples go through a three-day process in which the investigators extract and store serum, plasma, and cells for further analysis and gather proliferation data. The investigators use the saliva to measure the cortisol diurnal rhythm.
Conditions Studied
Interventions
- BEHAVIORAL Technology based cognitive behavioral stress management
- BEHAVIORAL Technology based health promotion group-based attention matched control condition
Study Locations (2)
Illinois
- Jesse Brown VA Medical Center - Chicago
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2012-05-25 |
| Est. Completion | 2018-04-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03149185
The ClinicalTrials.gov registry entry for NCT03149185 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (63% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Technology based cognitive behavioral stress management is the first listed.
NCT03149185 reports 2 study locations spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT03149185 about?
NCT03149185 is a clinical study titled "Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer". The purpose of this study is to examine the effects of various factors such as emotions, stress, stress management techniques (for example relaxation and coping techniques), and health information on quality of life, distress, depression, coping, and physical health in men diagnosed with advanced pr...
What is the current status of trial NCT03149185?
This trial is currently completed. It is a NA study. The enrollment target is 224 participants. The study started on 2012-05-25. Estimated completion is 2018-04-22.
What conditions does trial NCT03149185 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT03149185?
The interventions under investigation include: Technology based cognitive behavioral stress management (BEHAVIORAL), Technology based health promotion group-based attention matched control condition (BEHAVIORAL).
Who is sponsoring clinical trial NCT03149185?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03149185 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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