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Completed

NCT Number: NCT00784095

Outlook Quality of Life Intervention

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.

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Key information

Conditions

Cancer Cardiovascular Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Congestive Heart Failure Disease Attributes Heart Diseases Heart Failure Lung Diseases Lung Diseases, Obstructive Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center HSR&D COE

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with advanced cancer, CHF or COPD.

Exclusion criteria

Cognitive impairment, inability to speak, non-English speaking

Treatment and study plan

Life completion and preparation

Other

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

Attention Control

Other

Subjects will listen to a non-guided relaxation CD.

Primary outcomes

  1. Quality of Life - Preparation

    Time frame: Baseline, 6 and 8 week follow up

    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.

  2. QUAL-E Completion Sub-scale

    Time frame: Baseline, 6 and 8 week follow up

    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.

Secondary outcomes

  1. Functional Status ADL

    Time frame: Baseline, 6 and 8 week follow ups

    Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.

  2. Center for Epidemiology Studies - Depression Scale (CES-D)

    Time frame: Baseline, 6 and 8 week follow up

    Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.

  3. POMS Anxiety Sub-scale

    Time frame: Baseline, 6 and 8 week follow ups

    The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 5-25. Higher scores indicate greater anxiety.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 3, 2008
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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