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Sponsored by: |
Duke University |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00849498 |
The purpose of this study is 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. 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. With only 10 subjects per group the investigators 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. Type the research abstract in the box to the left. You can also copy and paste the abstract from another document.
Condition | Intervention |
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Brain Cancer |
Behavioral: coping skills training Behavioral: Usual care |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Coping With High Grade Glioma |
Estimated Enrollment: | 50 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Caregiver-Patient couples receiving active coping skills training.
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Behavioral: coping skills training
Caregiver-patient couples receiving coping skills training including problem solving,communication skills and managing activities.
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2: No Intervention
Caregiver-Patient couples receiving usual care.
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Behavioral: Usual care
Receiving usual care of the PRTBTC.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The caregiver may be a spouse/partner, family member or friend. Caregiver provides a weekly minimum of 4 hours of caregiving
Exclusion Criteria:
Contact: Bart Brigidi, PhD | 919-684-3121 | brigi002@mc.duke.edu |
Contact: Michelle Schroder | 919-681-5553 | michelle.schroder@duke.edu |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Bart Brigidi, PhD 919-684-3121 brigi002@mc.duke.edu | |
Contact: Michelle Schroder 919-681-5553 michelle.schroder@duke.edu | |
Principal Investigator: Bart Brigidi, PhD |
Principal Investigator: | Bart Brigidi, PhD | Duke University |
Responsible Party: | Duke University ( Bart Brigidi,PhD ) |
Study ID Numbers: | Pro00012826 |
Study First Received: | February 22, 2009 |
Last Updated: | February 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00849498 History of Changes |
Health Authority: | United States: Institutional Review Board |
Brain Cancer Coping Glioma National Brain Tumor Foundation Duke |
Neuroectodermal Tumors Brain Neoplasms Neoplasms, Germ Cell and Embryonal Neuroepithelioma Central Nervous System Diseases |
Central Nervous System Neoplasms Glioma Brain Diseases Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Brain Neoplasms Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |