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Coping With High Grade Glioma


N/A
18 Years
N/A
Not Enrolling
Both
Glioma

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Trial Information

Coping With High Grade Glioma


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. The
caregiver may be a spouse/partner, family member or friend,. Additional inclusion criteria
will include: (1) caregiver provides a weekly minimum of 4 hours of caregiving; (2)
caregiver is 18 years or older; (3) caregiver reading level at or above 8th grade; (4)
caregiver sufficiently fluent in English; (5) the patient shows evidence of problems in
depression, fatigue, sleep disturbance, and/or cognitive impairment as per the treating
neuro-oncologist; (6) the caregiver and patient are willing to be randomized to treatment
or usual care condition; (7) patient is within 3 months of initial diagnosis; (8) patient
has life expectancy of at least 6 months or more; (9) 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.

Using a randomized controlled, prospective design, potentially eligible participants will be
identified at the time of initial consultation. 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. If the subject is assigned to the
intervention, they will be asked to complete 12 weeks of a coping skills training
intervention. The coping skills intervention will consist of six telephone conversations
during which they will learn strategies to reduce stress. The strategies will include ways
to improve problem solving, communication skills, and managing activities. The subject will
also be asked to complete a packet of questionnaires which will take about 1 hour to do. The
subject will be asked to complete the questionnaires multiple times during the study (before
the coping skills intervention, during the week after the coping skills intervention, and 3
months after the coping skills intervention). If the subject is assigned to the usual care
condition, they will be asked to complete assessments at the same time intervals as
caregivers in the active coping skills intervention. In either condition, in the event that
the patient dies, the caregiver will also be asked to complete assessments every four months
for one year. Patients will be asked to participate in sessions and complete questionnaires
as they are able to.


Inclusion Criteria:



The caregiver may be a spouse/partner, family member or friend. Additional inclusion
criteria will include:

1. caregiver provides a weekly minimum of 4 hours of caregiving;

2. caregiver is 18 years or older;

3. caregiver reading level at or above 8th grade;

4. caregiver sufficiently fluent in English;

5. the patient shows evidence of problems in depression, fatigue, sleep disturbance,
and/or cognitive impairment as per the treating neuro-oncologist;

6. the caregiver and patient are willing to be randomized to treatment or usual care
condition;

7. patient is within 3 months of initial diagnosis;

8. patient has life expectancy of at least 6 months or more;

9. 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:

-

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Bart Brigidi, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00012826

NCT ID:

NCT00815152

Start Date:

December 2008

Completion Date:

October 2009

Related Keywords:

  • Glioma
  • high grade glioma
  • Coping skills intervention
  • caregivers
  • Glioma

Name

Location

The Preston Robert Tisch Brain Tumor Center at DukeDurham, North Carolina  27710