Coping With High Grade Glioma

NCT00815152 | Terminated DMC

• 1 other identifier: Pro00012826
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Purpose and Objective:
2. 2.Study Activities and Population Group:
3. 3.Data Analysis and Risk/Safety Issues:

Conditions

Glioma

Keywords

high grade glioma; Coping skills intervention; caregivers

Outcome Measures

Primary Outcomes (1)

• To explore the effects of a coping skills training (CST) intervention on distress, self-efficacy and other related outcomes among caregivers of high grade glioma patients.

  2 years

Study Arms (2)

1

EXPERIMENTAL

Twenty five caregivers will randomly be assigned to receive active coping skills training and 25 caregivers will randomly receive usual care at The Preston Robert Tisch Brain Tumor Center at Duke.

Behavioral: coping skills intervention training

2

PLACEBO COMPARATOR

Caregivers that will receive ususal care.

Behavioral: usual care

Interventions

coping skills intervention training BEHAVIORAL

The strategies will include ways to improve problem solving, communication skills, and managing activities.

1

usual care BEHAVIORAL

The ususal care at the Preston Robert Tisch Brain Tumor Center

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Brain Tumor Foundation(NBTF): collaborator

Study Sites (1)

The Preston Robert Tisch Brain Tumor Center at Duke

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Bart Brigidi, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2008
• First Posted: December 29, 2008
• Study Start: December 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 6, 2013

Record last verified: 2010-10

Locations

US (1)