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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00939146
First received: July 10, 2009
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

This study will demonstrate whether an end-of-life preparation and completion intervention reduces anxiety, depression, pain and other symptoms and improves functional status, spiritual well-being, and quality of life. If effective, the intervention offers a brief, inexpensive, and transportable non-physician treatment method for improving the experience of individuals in the latter stages of life-limiting illness.


Condition Intervention
Neoplasms
Pulmonary Disease, Chronic Obstructive
Heart Failure
Renal Disease
Other: Outlook Attention Control
Other: Outlook Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Outlook: An Intervention to Improve Quality of Life in Serious Illness

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • QUAL-E subscale describing preparation for death (Quality of Life at End of Life, Steinhauser et al. 2004) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remaining subscales of the QUAL-E instrument (Quality of Life at End of Life, Steinhauser et al. 2004) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]

Enrollment: 154
Study Start Date: February 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Outlook Attention Control
Subjects in the relaxation meditation group will meet with a facilitator three times, for a period of forty-five minutes each; they will listen to a non-guided relaxation CD.
Other: Outlook Attention Control
Subjects in the relaxation meditation group will meet with a facilitator three times, for a period of forty-five minutes each; they will listen to a non-guided relaxation CD.
Outlook Intervention
The Outlook intervention is designed to assist patients self-manage role changes by guiding them through life review, current issues of forgiveness and conflict resolution, and future orientation, with planning heritage and legacy.
Other: Outlook Intervention
The Outlook intervention is designed to assist patients self-manage role changes by guiding them through life review, current issues of forgiveness and conflict resolution, and future orientation, with planning heritage and legacy.

Detailed Description:

Efforts to improve end-of-care often focus on pain and symptom control, but few, if any, effective interventions exist addressing preparation and completion. We designed an end-of-life preparation and completion intervention, based on the human development literature identifying life completion as a developmental task and the robust evidence in health communication and clinical psychology that addresses the value of expressing emotions and stress on health outcomes. Our specific aims are 1) evaluate the impact of an intervention that promotes discussions of end-of-life preparation and completion on health outcomes in dying persons, including pain and symptoms, physical function, emotional function (anxiety and depression), spiritual well-being, and quality of life at the end of life and 2) evaluate the content of the such discussions, examining task variation associated with gender, ethnicity, socio-economic status, quality of communication with family, spirituality, and stage of illness to improve understanding of the need for tailored intervention content based on demographics or location in the trajectory of illness. We propose a randomized control trial to evaluate the intervention. 140 patients with advanced cancer, CHF, ESRD, or COPD will be randomly assigned into one of two 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 forty-five minutes each. In the first session, subjects will be asked to discuss issues related to life review. A week later, participants will be asked to speak in more depth about issues such as regret, forgiveness and things left undone. In the final session, a week hence, 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 forty-five minutes each and be asked to listen to a non-guided relaxation CD. One week and two weeks later, participants in all groups will receive post-test measures administered by a blinded interviewer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible patients must have advanced life-limiting illness as determined by clinical criteria indicative of advance disease. Must be diagnosed with one of the following:

  • Cancer: Stage IV metastatic cancer, pancreatic and lung cancers may include Stages III and IV, recurrent/refractory disease (multiple myeloma and related cancers);
  • Congestive Heart Failure: NYHA Class III or IV;
  • End-Stage Renal Disease: Dialysis dependent;
  • Chronic Obstructive Pulmonary Disease: Oxygen dependent.

Also, eligible patients must receive care for one of the diseases above at Duke University Medical Center, have access to a telephone, live within a 35-mile radius of Durham, be at least 18 years of age, English speaking, and cognitively capable to give informed consent.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939146

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Karen Steinhauser, PhD Duke University
Principal Investigator: James A Tulsky, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00939146     History of Changes
Other Study ID Numbers: Pro00011193, 1P01NR010948-01
Study First Received: July 10, 2009
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
self management
quality of life
end of life

Additional relevant MeSH terms:
Neoplasms
Chronic Disease
Heart Failure
Kidney Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on July 20, 2014