Outlook Quality of Life Intervention

NCT ID: NCT00784095

Last Updated: 2016-03-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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This is a pilot randomized control trial to evaluate the feasibility of the Outlook intervention. 36 veterans with advanced cancer, congestive heart failure (CHF) or chronic obstructive pulmonary disease (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 compact disk (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.

Conditions

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Cancer Congestive Heart Failure Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Preparation and Completion

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.

Group Type EXPERIMENTAL

Life completion and preparation

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Attention Control

Intervention Type OTHER

Subjects will listen to a non-guided relaxation CD.

True Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Life completion and preparation

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

Intervention Type OTHER

Attention Control

Subjects will listen to a non-guided relaxation CD.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients with advanced cancer, CHF or COPD.

Exclusion Criteria

Cognitive impairment, inability to speak, non-English speaking
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen E. Steinhauser, PhD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center HSR&D COE

Locations

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Durham VA Medical Center HSR&D COE

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24803020 (View on PubMed)

Other Identifiers

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IAD 07-162

Identifier Type: -

Identifier Source: org_study_id

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