Outlook Quality of Life Intervention Study

Not Applicable

Completed

Conditions: Cancer
Congestive Heart Failure (CHF)
Chronic Obstructive Pulmonary Disease (COPD)
End Stage Renal Disease (ESRD)

Interventions: Other: Life Completion
Other: Attention Control

Registration Number: NCT01044290

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 randomized control trial to evaluate the feasibility of the Outlook intervention. 221 veterans with advanced cancer, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or end stage renal disease (ESRD) were randomly assigned to one of three intervention groups and completed a brief battery of pre-test measures. Subjects in the first group ("Outlook Intervention") were randomized to meet with a facilitator three times for a period of 45 min-1 hour. Participants were asked in the first session to discuss issues related to life review. They were asked in the second session to speak in more depth about issues of regret, forgiveness and things left undone. The subject of the final session was heritage and legacy. Participants in the attention control group were randomized to meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation audio disc (CD). Participants in the third group ("treatment as usual") were exposed to no interventional sessions. Participants were assessed with post-test measures administered by a blinded interviewer one week and 3 weeks after the intervention window.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 221

Inclusion Criteria

Patients with
Advanced cancer
Congestive heart failure
COPD
End stage renal disease

Exclusion Criteria

Cognitive impairment
inability to speak
non-English speaking

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outlook Intervention	Life Completion	Subjects in the first group ("Life Completion") completed a psychosocial intervention which consisted of meeting with the facilitator three times for 45-60 minutes each. 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 focused on heritage and legacy.
Attention Control	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.

Primary Outcome Measures

Name	Time	Method
QUAL-E Life Completion Sub-scale	Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64)	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. We include the 7-item life completion sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 7 and maximum was 35 with higher scores indicating greater completion.
QUAL-E - Preparation Sub-scale	Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)	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. We include the 4-item preparation sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 5 and maximum was 20 with higher numbers indicating higher preparation.

Secondary Outcome Measures

Name	Time	Method
CES-D	Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64)	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.
FACIT-SP	Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63)	The Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (Facit-SP) is a 12-item measure of faith, meaning and purpose, with a range of 0 to 48. Higher scores indicate greater spiritual well-being.
POMS Anxiety Sub-scale	Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64)	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 0-20. Higher scores indicate greater anxiety.
FACT-G - Social Sub-scale	Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64)	Functional assessment of Cancer Therapy-General) is a 27 item survey which assesses physical, social/family, emotional, and functional well being. This sub-scale assesses social well-being. We omitted an item assessing satisfaction with sex life, due to high missing data. Items are rated on a 5 point likert scale, with 0 indicating "not at all" and 4 indicating, "very much" in response to item questions. Total sub-scale range is 0 to 30, with higher scores indicating better well-being.