Full Text View
Tabular View
No Study Results Posted
Related Studies
Coping With Glioma
This study is currently recruiting participants.
Verified by Duke University, February 2009
First Received: February 22, 2009   Last Updated: February 23, 2009   History of Changes
Sponsored by: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00849498
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Rate of adherence to coping skills training [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of time on caregiver distress,strain and quality of life,as well as patient neuropsychiatric symptoms,objective neurocognitive performance and perceived cognitive ability. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
1: Experimental
Caregiver-Patient couples receiving active coping skills training.
Behavioral: coping skills training
Caregiver-patient couples receiving coping skills training including problem solving,communication skills and managing activities.
2: No Intervention
Caregiver-Patient couples receiving usual care.
Behavioral: Usual care
Receiving usual care of the PRTBTC.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Caregivers will be defined as those individuals providing primary care for a patient with pathology confirmed high grade glioma (WHO grades III or IV) attending their treatment consultation at the Preston Robert Tisch Brian Tumor Center at Duke (PRT-BTC).
  • The caregiver may be a spouse/partner, family member or friend. Caregiver provides a weekly minimum of 4 hours of caregiving

    • caregiver is 18 years or older
    • caregiver reading level at or above 8th grade
    • caregiver sufficiently fluent in English
    • the patient shows evidence of problems in depression, fatigue, sleep disturbance, and/or cognitive impairment as per the treating neuro-oncologist *the caregiver and patient are willing to be randomized to treatment or usual care condition
    • patient is within 3 months of initial diagnosis
    • patient has life expectancy of at least 6 months or more
    • the caregiver is willing to participate in treatment sessions using a telephone.
  • If a patient dies during the active 12-week study phase, then the caregiver will be transitioned to the follow-up phase or removed from the study and, if needed, be referred for appropriate psychiatric or psychological treatment.

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849498

Contacts
Contact: Bart Brigidi, PhD 919-684-3121 brigi002@mc.duke.edu
Contact: Michelle Schroder 919-681-5553 michelle.schroder@duke.edu

Locations
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            
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Bart Brigidi, PhD Duke University
  More Information

Additional Information:
PRTBTC  This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Duke University:
Brain Cancer
Coping
Glioma
National Brain Tumor Foundation
Duke

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 30, 2009