MedPath

Outlook Quality of Life Intervention

Not Applicable
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Cancer
Congestive Heart Failure
Interventions
Other: Attention Control
Other: Life completion and preparation
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.

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
Arm && Interventions
GroupInterventionDescription
Attention ControlAttention ControlThe subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.
Preparation and CompletionLife completion and preparationSubjects 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.
Primary Outcome Measures
NameTimeMethod
Quality of Life - PreparationBaseline, 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-scaleBaseline, 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
NameTimeMethod
Functional Status ADLBaseline, 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-scaleBaseline, 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

© Copyright 2025. All Rights Reserved by MedPath