Outlook Quality of Life Intervention Study

NCT01044290 | Completed Results

• 1 other identifier: IIR 10-050
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• QUAL-E - Preparation Sub-scale

  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.

  Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)

• QUAL-E Life Completion Sub-scale

  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.

  Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64)

Secondary Outcomes (4)

• POMS Anxiety Sub-scale

  Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64)

• CES-D

  Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64)

• FACIT-SP

  Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63)

• FACT-G - Social Sub-scale

  Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64)

Study Arms (3)

Outlook Intervention

EXPERIMENTAL

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

Attention Control

ACTIVE COMPARATOR

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

Treatment as Usual

NO INTERVENTION

Subjects in the third group ("treatment as usual") were exposed to no intervention or attention control during the intervention window.

Interventions

Life Completion OTHER

Subjects discussed life review, issues of forgiveness and heritage and legacy.

Outlook Intervention

Attention Control OTHER

Subjects listened to a non-guided relaxation CD

Attention Control

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center HSR&D COE

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• 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.

  PMID: 25003541 BACKGROUND

• 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.

  PMID: 28803082 DERIVED

MeSH Terms

Conditions

Neoplasms; Heart Failure; Pulmonary Disease, Chronic Obstructive; Kidney Failure, Chronic; Death

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Karen Steinhauser, PhD
• Organization: HSRD, Durham VAMC

karen.steinhauser@duke.edu

919 668-2148

Study Officials

• Karen E. Steinhauser, PhD

  Durham VA Medical Center HSR&D COE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: January 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 20, 2015
• Results First Posted: October 19, 2015

Record last verified: 2015-10

Locations

US (1)