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NCT00006253 · ClinicalTrials.gov registry record · NA
Pain and Fatigue Study
A NA study, sponsored by Michigan State University.
- Completed
- Registry status
- NA
- Development phase
- 350
- Enrollment target
NCT00006253 is a NA study that has completed, run by Michigan State University. The registered enrollment target is 350 participants.
The verdict
NCT00006253, a NA study, has completed, sponsored by Michigan State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 350 participants
- Enrollment target
Study Summary
Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management attention control (SMAC) intervention, or to a 8-week, 6-contact experimental patient intervention for management of symptoms and support (PIMSS) targeted toward symptom management, reducing impact on physical role and social functioning and emotional distress. Both groups will continue to receive conventional cancer care. When compared with the self-management attention control intervention, patients exposed to the experimental intervention will report statistically significant positive effects on the following: 1. The primary outcome--total number of symptoms reported; 2. The secondary patient outcomes--reduced deterioration in physical role impact and social functioning, emotional distress, levels of communication with caregiver about care, and communication and satisfaction with provider care; and 3. Caregiver outcomes--greater involvement in symptom management, increased mastery of the caregiving process, reduced levels of depression and burden.
Interventions
- BEHAVIORAL Nurse
- BEHAVIORAL Non-nurse coach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2003-03 |
| Est. Completion | 2006-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006253
The ClinicalTrials.gov registry entry for NCT00006253 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michigan State University, which has 120 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nurse is the first listed.
NCT00006253 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006253 about?
NCT00006253 is a clinical study titled "Pain and Fatigue Study". Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management attention control (SMAC) in...
What is the current status of trial NCT00006253?
This trial is currently completed. It is a NA study. The enrollment target is 350 participants. The study started on 2003-03. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00006253?
The interventions under investigation include: Nurse (BEHAVIORAL), Non-nurse coach (BEHAVIORAL).
Who is sponsoring clinical trial NCT00006253?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
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