Coping With High Grade Glioma

Stopped early · Not applicable

Conditions studied: Glioma

In brief

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.

Key facts

Study ID

NCT00815152

Run by

Duke University

People needed

14

Starts

2008-12-01

Expected to finish

2009-10-01

Last updated by the study team

2013-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

• The Preston Robert Tisch Brain Tumor Center at Duke — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.