Coping With High Grade Glioma

NCT ID: NCT00815152

Last Updated: 2013-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-10-31

Brief 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.

Detailed Description

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.

Conditions

Glioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: EXPERIMENTAL

coping skills intervention training

Intervention Type: BEHAVIORAL

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

2

Caregivers that will receive ususal care.

Group Type: PLACEBO_COMPARATOR

usual care

Intervention Type: BEHAVIORAL

The ususal care at the Preston Robert Tisch Brain Tumor Center

Interventions

coping skills intervention training

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

Intervention Type: BEHAVIORAL

usual care

The ususal care at the Preston Robert Tisch Brain Tumor Center

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Brain Tumor Foundation(NBTF)

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bart Brigidi, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

The Preston Robert Tisch Brain Tumor Center at Duke

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00012826

Identifier Type: -

Identifier Source: org_study_id

NCT00849498

Identifier Type: -

Identifier Source: nct_alias