Outlook Quality of Life Intervention

Cancer Clinical Trial

Official title:

Outlook: An Intervention to Improve Quality of Life in Serious Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784095
• Other study ID #: IAD 07-162
• Secondary ID: IAD 07-162
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: August 6, 2014
• Start date: December 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

This is a pilot randomized control trial to evaluate the feasibility of the Outlook intervention. 36 veterans with advanced cancer, CHF or COPD will be randomly assigned to one of three intervention groups and complete a brief battery of pre-test measures. Subjects in the first group ("treatment") will meet with a facilitator three times for a period of 45 min-1 hour. In the first session, subjects will be asked to discuss issues related to life review. In the second session, participants will be asked to speak in more depth about issues such as regret, forgiveness and things left undone, In the final session, subjects will focus on heritage and legacy. The subjects in the second group ("attention control") will meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation CD. The third group of participants ("true control") will be exposed to no intervention or attention control. One week and two weeks later, participants in all groups will receive post-test measures administered by a blinded interviewer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with advanced cancer, CHF or COPD.

Exclusion Criteria:

Cognitive impairment, inability to speak, non-English speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer
• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Heart Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Life completion and preparation
Subjects will discuss life review, issues of forgiveness and heritage and legacy.
• Attention Control
Subjects will listen to a non-guided relaxation CD.

Locations

Country	Name	City	State
United States	Durham VA Medical Center HSR&D COE	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & 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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		8 weeks	No
Secondary	MD Anderson Symptom Inventory		8 weeks	No
Secondary	CESD short version		8 weeks	No
Secondary	POMS anxiety sub-scale		8 weeks	No
Secondary	FACIT-sp		8 weeks	No