Outlook Quality of Life Intervention Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01044290
First received: January 5, 2010
Last updated: October 19, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention
Cancer
Congestive Heart Failure (CHF)
Chronic Obstructive Pulmonary Disease (COPD)
End Stage Renal Disease (ESRD)
Other: Life Completion
Other: Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Outlook: An Intervention to Improve Quality of Life in Serious Illness Study

Further study details as provided by VA Office of Research and Development:

Primary Outcome 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • POMS Anxiety Sub-scale [ Time Frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 221
Study Start Date: January 2011
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Life Completion
Subjects discussed life review, issues of forgiveness and 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.
Other: Attention Control
Subjects 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.

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

Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044290

Locations
United States, North Carolina
Durham VA Medical Center HSR&D COE
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Karen E. Steinhauser, PhD Durham VA Medical Center HSR&D COE
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01044290     History of Changes
Other Study ID Numbers: IIR 10-050 
Study First Received: January 5, 2010
Results First Received: February 23, 2015
Last Updated: October 19, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
quality of life
end of life
self-disclosure
palliative care

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 26, 2016