Outlook Quality of Life Intervention

NCT00784095 | Completed Results

• 1 other identifier: IAD 07-162
• Study Type: interventional
• Target: 36
• 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; Chronic Obstructive Pulmonary Disease

Keywords

quality of life

Outcome Measures

Primary Outcomes (2)

• Quality of Life - Preparation

  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. The 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.

  Baseline, 6 and 8 week follow up

• QUAL-E Completion Sub-scale

  A sub-scale of the QUAL-E quality of life at the end of life measures. The scale range was 5-35 with higher scores indicating more positive sense of completion.

  Baseline, 6 and 8 week follow up

Secondary Outcomes (3)

• Functional Status ADL

  Baseline, 6 and 8 week follow ups

• Center for Epidemiology Studies - Depression Scale (CES-D)

  Baseline, 6 and 8 week follow up

• POMS Anxiety Sub-scale

  Baseline, 6 and 8 week follow ups

Study Arms (3)

Preparation and Completion

EXPERIMENTAL

Subjects in the first group ("treatment") met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. 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 discussed issues of heritage and legacy.

Other: Life completion and preparation

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

True Control

NO INTERVENTION

Subjects in the third group ("true control") were exposed to no intervention or attention control.

Interventions

Life completion and preparation OTHER

Subjects will discuss life review, issues of forgiveness and heritage and legacy.

Preparation and Completion

Attention Control OTHER

Subjects will listen to a non-guided relaxation CD.

Attention Control

Eligibility Criteria

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

You may qualify if:

• Patients with advanced cancer, CHF or COPD.

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 (1)

• Sautter JM, Tulsky JA, Johnson KS, Olsen MK, Burton-Chase AM, Lindquist JH, Zimmerman S, Steinhauser KE. Caregiver experience during advanced chronic illness and last year of life. J Am Geriatr Soc. 2014 Jun;62(6):1082-90. doi: 10.1111/jgs.12841. Epub 2014 May 6.

  PMID: 24803020 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Heart Failure; Pulmonary Disease, Chronic Obstructive

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

Limitations and Caveats

Therefore, due to the small sample size, finding are met with caution. Subjects were not randomized by any condition. As a result, those in the Control arm were more functionally able than the other two arms at baseline.

Results Point of Contact

• Title: Dr. Karen Steinhauser
• Organization: VA Health Services Research and Development

karen.steinhauser@va.gov

9196682148

Study Officials

• Karen E. Steinhauser, PhD

  Durham VA Medical Center HSR&D COE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: November 3, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 22, 2016
• Results First Posted: March 22, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)