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Outlook Quality of Life Intervention Study

NCT ID: NCT01044290

Last Updated: 2015-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-04-30

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 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.

Conditions

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Cancer Congestive Heart Failure (CHF) Chronic Obstructive Pulmonary Disease (COPD) End Stage Renal Disease (ESRD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Life Completion

Intervention Type OTHER

Subjects discussed 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 listened to a non-guided relaxation CD

Treatment as Usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Life Completion

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

Intervention Type OTHER

Attention Control

Subjects listened to a non-guided relaxation CD

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

95 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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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.

Reference Type BACKGROUND
PMID: 25003541 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28803082 (View on PubMed)

Other Identifiers

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IIR 10-050

Identifier Type: -

Identifier Source: org_study_id