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Outlook Quality of Life Intervention Study

This study is currently recruiting participants.
Verified January 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01044290
First received: January 5, 2010
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness.


Condition Intervention
Cancer
Congestive Heart Failure (CHF)
Chronic Obstructive Pulmonary Disease (COPD)
End Stage Renal Disease (ESRD)
 Other: Life Completion
Other: Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Outlook: An Intervention to Improve Quality of Life in Serious Illness Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FACT-G [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • POMS Anxiety Sub-scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CESD [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  • OARS ADLS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • FACIT-SP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: January 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Subjects in the first group ("treatment") will meet with the facilitator three times for a period of forty-five minutes to one hour. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.
 Other: Life Completion
Subjects will discuss life review, issues of forgiveness and heritage and legacy.
Active Comparator: Arm 2
The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD
 Other: Attention Control
Subjects will listen to a non-guided relaxation CD
No Intervention: Arm 3
Subjects in the third group ("true control") will be exposed to no intervention or attention control.

Detailed Description:

This is a randomized control trial to evaluate the feasibility of the Outlook intervention. 225 veterans with advanced cancer, Congestive Heart Failure (CHF) or chronic obstructive pulmonary disease (COPD) or end stage renal disease will be randomly assigned to one of three intervention groups and complete a brief battery of pre-test measures. Subjects in the first group ("treatment") will meet with a facilitator three times for a period of 45 min-1 hour. In the first session, subjects will be asked to discuss issues related to life review. In the second session, participants will be asked to speak in more depth about issues such as regret, forgiveness and things left undone, In the final session, subjects will focus on heritage and legacy. The subjects in the second group ("attention control") will meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation CD. The third group of participants ("true control") will be exposed to no intervention or attention control. One week and two weeks later, participants in all groups will receive post-test measures administered by a blinded interviewer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with advanced cancer
  • Congestive heart failure
  • COPD
  • End stage renal disease

Exclusion Criteria:

  • Cognitive impairment
  • inability to speak
  • non-English speaking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044290

Contacts
Contact: Jennifer B Zervakis, PhD (919) 286-6936 jennifer.zervakis@va.gov

Locations
United States, North Carolina
Durham VA Medical Center HSR&D COE Recruiting
Durham, North Carolina, United States, 27705
Contact: Susan B Armstrong     919-286-6936     beth.armstrong@va.gov    
Contact: Dana C Tucker     (919) 286-0411 ext 5741     dana.tucker@va.gov    
Sub-Investigator: James A. Tulsky, MD            
Principal Investigator: Karen E. Steinhauser, PhD            
Sub-Investigator: Stewart C. Alexander, BA MA PhD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Karen E. Steinhauser, PhD Durham VA Medical Center HSR&D COE
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01044290     History of Changes
Other Study ID Numbers: IIR 10-050
Study First Received: January 5, 2010
Last Updated: January 31, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
quality of life
end of life
self-disclosure

Additional relevant MeSH terms:
Heart Failure
Kidney Diseases
Kidney Failure, Chronic
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
 Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013