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NCT00815152 · ClinicalTrials.gov registry record · NA
Coping With High Grade Glioma
A NA study, sponsored by Duke University.
- Terminated
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT00815152 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 14 participants.
The verdict
NCT00815152, a NA study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
1. Purpose and Objective: To determine the feasibility and short- and long-term efficacy of an empirically-based CST intervention (Keefe et al.) with caregivers of patients with primary malignant brain cancer. 2. Study Activities and Population Group: The target sample will be 20 caregiver-patient dyads. Using a randomized controlled, prospective design, potentially eligible participants will be identified at the time of initial consultation (see Figure 1). Outcomes will be assessed at baseline, post-intervention (3 months post-randomization), 6 months post-randomization, and every 4 months up to 2-years in the event that the patient dies. 3. Data Analysis and Risk/Safety Issues: With only 10 subjects per group we do not have statistical power for direct hypothesis testing. Nevertheless, p-values will be presented for some analyses (chi-square tests, t-tests, and Spearman correlations) simply to aid in interpretation of results. In no way will these p-values be used to declare statistical significance or non-significance of the test results. Accordingly, the primary focus will be the means, variances, and covariances of the study endpoints, as well as the change scores in these endpoints across the study intervention and their 95% confidence limits.
Interventions
- BEHAVIORAL usual care
- BEHAVIORAL coping skills intervention training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00815152
The ClinicalTrials.gov registry entry for NCT00815152 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which usual care is the first listed.
NCT00815152 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00815152 about?
NCT00815152 is a clinical study titled "Coping With High Grade Glioma". 1. Purpose and Objective: To determine the feasibility and short- and long-term efficacy of an empirically-based CST intervention (Keefe et al.) with caregivers of patients with primary malignant brain cancer. 2. Study Activities and Population Group: The target sample will be 20 caregiver-p...
What is the current status of trial NCT00815152?
This trial is currently terminated. It is a NA study. The enrollment target is 14 participants. The study started on 2008-12. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00815152?
The interventions under investigation include: usual care (BEHAVIORAL), coping skills intervention training (BEHAVIORAL).
Who is sponsoring clinical trial NCT00815152?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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