- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00939146
Outlook: An Intervention to Improve Quality of Life in Serious Illness
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Eligible patients must have advanced life-limiting illness as determined by clinical criteria indicative of advance disease. Must be diagnosed with one of the following:
- Cancer: Stage IV metastatic cancer, pancreatic and lung cancers may include Stages III and IV, recurrent/refractory disease (multiple myeloma and related cancers);
- Congestive Heart Failure: NYHA Class III or IV;
- End-Stage Renal Disease: Dialysis dependent;
- Chronic Obstructive Pulmonary Disease: Oxygen dependent.
Also, eligible patients must receive care for one of the diseases above at Duke University Medical Center, have access to a telephone, live within a 35-mile radius of Durham, be at least 18 years of age, English speaking, and cognitively capable to give informed consent.
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Outlook Attention Control
Subjects in the relaxation meditation group will meet with a facilitator three times, for a period of forty-five minutes each; they will listen to a non-guided relaxation CD.
|
Subjects in the relaxation meditation group will meet with a facilitator three times, for a period of forty-five minutes each; they will listen to a non-guided relaxation CD.
|
OTHER: Outlook Intervention
The Outlook intervention is designed to assist patients self-manage role changes by guiding them through life review, current issues of forgiveness and conflict resolution, and future orientation, with planning heritage and legacy.
|
The Outlook intervention is designed to assist patients self-manage role changes by guiding them through life review, current issues of forgiveness and conflict resolution, and future orientation, with planning heritage and legacy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
QUAL-E subscale describing preparation for death (Quality of Life at End of Life, Steinhauser et al. 2004)
Time Frame: Eight weeks
|
Eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Remaining subscales of the QUAL-E instrument (Quality of Life at End of Life, Steinhauser et al. 2004)
Time Frame: Eight weeks
|
Eight weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James A Tulsky, MD, Duke University
- Principal Investigator: Karen Steinhauser, PhD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00011193
- 1P01NR010948-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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