Ignite Creation Date:
2024-05-05 @ 9:05 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00815152
Status:
TERMINATED
Last Update Posted:
2013-05-06
First Post:
2008-12-26
Brief Title:
Coping With High Grade Glioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Coping With High Grade Glioma
Status:
TERMINATED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI transferred to new institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 RiskSafety 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
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 RiskSafety 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 spousepartner 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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None