Clinical trial NCT01044290: Outlook Quality of Life Intervention Study
Official title: Outlook: An Intervention to Improve Quality of Life in Serious Illness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Congestive Heart Failure (CHF)
Chronic Obstructive Pulmonary Disease (COPD)
End Stage Renal Disease (ESRD)
Keywords: quality of life
end of life
self-disclosure
palliative care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-01-07
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Cognitive impairment
* inability to speak
* non-English speaking

Primary outcomes:
measure: QUAL-E - Preparation Sub-scale
timeFrame: Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)
measure: QUAL-E Life Completion Sub-scale
timeFrame: Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64)
Secondary outcomes:
measure: POMS Anxiety Sub-scale
timeFrame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64)
measure: CES-D
timeFrame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64)
measure: FACIT-SP
timeFrame: Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63)
measure: FACT-G - Social Sub-scale
timeFrame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center HSR&D COE
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center HSR&D COE
name: Karen E. Steinhauser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steinhauser KE, Voils CI, Bosworth H, Tulsky JA. What constitutes quality of family experience at the end of life? Perspectives from family members of patients who died in the hospital. Palliat Support Care. 2015 Aug;13(4):945-52. doi: 10.1017/S1478951514000807. Epub 2014 Jul 8.
citation: Steinhauser KE, Alexander S, Olsen MK, Stechuchak KM, Zervakis J, Ammarell N, Byock I, Tulsky JA. Addressing Patient Emotional and Existential Needs During Serious Illness: Results of the Outlook Randomized Controlled Trial. J Pain Symptom Manage. 2017 Dec;54(6):898-908. doi: 10.1016/j.jpainsymman.2017.06.003. Epub 2017 Aug 10.