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Outlook Quality of Life Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00784095
First received: October 30, 2008
Last updated: April 23, 2012
Last verified: January 2011
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
Chronic Obstructive Pulmonary Disease
 Other: Life completion and preparation
Other: Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Outlook: An Intervention to Improve Quality of Life in Serious Illness

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:
  • MD Anderson Symptom Inventory [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CESD short version [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • POMS anxiety sub-scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • FACIT-sp [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: December 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (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 our. 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 and preparation
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 pilot randomized control trial to evaluate the feasibility of the Outlook intervention. 36 veterans with advanced cancer, CHF or COPD 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, CHF or COPD.

Exclusion Criteria:

Cognitive impairment, inability to speak, non-English speaking

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784095

Locations
United States, North Carolina
Durham VA Medical Center HSR&D COE
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Karen E. Steinhauser, PhD Durham VA Medical Center HSR&D COE
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00784095     History of Changes
Other Study ID Numbers: IAD 07-162, IIR 07-116
Study First Received: October 30, 2008
Last Updated: April 23, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
quality of life

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

ClinicalTrials.gov processed this record on May 22, 2013