Outlook Quality of Life Intervention Study

Overview

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.

Full Title of Study: “Outlook: An Intervention to Improve Quality of Life in Serious Illness Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2014

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.

Interventions

  • Other: Life Completion
    • Subjects discussed life review, issues of forgiveness and heritage and legacy.
  • Other: Attention Control
    • Subjects listened to a non-guided relaxation CD

Arms, Groups and Cohorts

  • Experimental: Outlook Intervention
    • 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.
  • 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.
  • No Intervention: Treatment as Usual
    • Subjects in the third group (“treatment as usual”) were exposed to no intervention or attention control during the intervention window.

Clinical Trial Outcome Measures

Primary Measures

  • QUAL-E – Preparation Sub-scale
    • Time Frame: 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.
  • QUAL-E Life Completion Sub-scale
    • Time Frame: 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.

Secondary Measures

  • POMS Anxiety Sub-scale
    • Time Frame: 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.
  • CES-D
    • Time Frame: 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
    • Time Frame: 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.
  • FACT-G – Social Sub-scale
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with – Advanced cancer – Congestive heart failure – COPD – End stage renal disease Exclusion Criteria:

  • Cognitive impairment – inability to speak – non-English speaking

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Office of Research and Development
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Karen E. Steinhauser, PhD, Principal Investigator, Durham VA Medical Center HSR&D COE

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.