Outlook Quality of Life Intervention

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Cancer; Congestive Heart Failure

• Registration Number: NCT00784095
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-11-02
• Study Start: 2008-12
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2014-10-03
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-11
• Last Update Submitted: 2016-03-11
• Results First Posted: 2016-03-22
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Patients with advanced cancer, CHF or COPD.

Exclusion Criteria

Cognitive impairment, inability to speak, non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of Life - Preparation	Baseline, 6 and 8 week follow up	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	Baseline, 6 and 8 week follow up	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

Name	Time	Method
Functional Status ADL	Baseline, 6 and 8 week follow ups	Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.
Center for Epidemiology Studies - Depression Scale (CES-D)	Baseline, 6 and 8 week follow up	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	Baseline, 6 and 8 week follow ups	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.

Trial Locations

Locations (1)

Durham VA Medical Center HSR&D COE; 🇺🇸 Durham, North Carolina, United States