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

18 Years
Open (Enrolling)
Neoplasms, Pulmonary Disease, Chronic Obstructive, Heart Failure, Renal Disease

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

QUAL-E subscale describing preparation for death (Quality of Life at End of Life, Steinhauser et al. 2004)

Outcome Time Frame:

Eight weeks

Safety Issue:


Principal Investigator

Karen Steinhauser, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:




Start Date:

February 2010

Completion Date:

July 2013

Related Keywords:

  • Neoplasms
  • Pulmonary Disease, Chronic Obstructive
  • Heart Failure
  • Renal Disease
  • self management
  • quality of life
  • end of life
  • Neoplasms
  • Chronic Disease
  • Heart Failure
  • Kidney Diseases
  • Lung Diseases
  • Respiration Disorders
  • Pulmonary Disease, Chronic Obstructive



Duke University Medical Center Durham, North Carolina  27710