Outlook Quality of Life Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00784095
First received: October 30, 2008
Last updated: March 11, 2016
Last verified: March 2016
  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

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Quality of Life - Preparation [ Time Frame: Baseline, 6 and 8 week follow up ] [ Designated as safety issue: No ]
    Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.

  • QUAL-E Completion Sub-scale [ Time Frame: Baseline, 6 and 8 week follow up ] [ Designated as safety issue: No ]
    A sub-scale of the QUAL-E quality of life at the end of life measures. The scale range was 5-35 with higher scores indicating more positive sense of completion.


Secondary Outcome Measures:
  • Functional Status ADL [ Time Frame: Baseline, 6 and 8 week follow ups ] [ Designated as safety issue: No ]
    Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.

  • Center for Epidemiology Studies - Depression Scale (CES-D) [ Time Frame: Baseline, 6 and 8 week follow up ] [ Designated as safety issue: No ]
    Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.

  • POMS Anxiety Sub-scale [ Time Frame: Baseline, 6 and 8 week follow ups ] [ Designated as safety issue: No ]
    The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 5-25. Higher scores indicate greater anxiety.


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: Preparation and Completion
Subjects in the first group ("treatment") met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.
Other: Life completion and preparation
Subjects will discuss life review, issues of forgiveness and heritage and legacy.
Active Comparator: Attention Control
The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.
Other: Attention Control
Subjects will listen to a non-guided relaxation CD.
No Intervention: True Control
Subjects in the third group ("true control") were 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, congestive heart failure (CHF) or chronic obstructive pulmonary disease (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 compact disk (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
VA Office of Research and Development
Investigators
Principal Investigator: Karen E. Steinhauser, PhD Durham VA Medical Center HSR&D COE
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00784095     History of Changes
Other Study ID Numbers: IAD 07-162 
Study First Received: October 30, 2008
Results First Received: October 3, 2014
Last Updated: March 11, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
quality of life

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

ClinicalTrials.gov processed this record on July 26, 2016