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Completed

NCT Number: NCT01044290

Outlook Quality of Life Intervention Study

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 (COPD) Congestive Heart Failure (CHF) Death Disease Attributes End Stage Renal Disease (ESRD) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Kidney Failure, Chronic Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–95 year

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 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Cognitive impairment
  • inability to speak
  • non-English speaking

Treatment and study plan

Life Completion

Other

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

Attention Control

Other

Subjects listened to a non-guided relaxation CD

Primary outcomes

  1. QUAL-E - Preparation Sub-scale

    Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)

    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. We include the 4-item preparation sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 5 and maximum was 20 with higher numbers indicating higher preparation.

  2. QUAL-E Life Completion Sub-scale

    Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64)

    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. We include the 7-item life completion sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 7 and maximum was 35 with higher scores indicating greater completion.

Secondary outcomes

  1. POMS Anxiety Sub-scale

    Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64)

    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 0-20. Higher scores indicate greater anxiety.

  2. CES-D

    Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64)

    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. FACIT-SP

    Time frame: Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63)

    The Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (Facit-SP) is a 12-item measure of faith, meaning and purpose, with a range of 0 to 48. Higher scores indicate greater spiritual well-being.

  4. FACT-G - Social Sub-scale

    Time frame: Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64)

    Functional assessment of Cancer Therapy-General) is a 27 item survey which assesses physical, social/family, emotional, and functional well being. This sub-scale assesses social well-being. We omitted an item assessing satisfaction with sex life, due to high missing data. Items are rated on a 5 point likert scale, with 0 indicating "not at all" and 4 indicating, "very much" in response to item questions. Total sub-scale range is 0 to 30, with higher scores indicating better well-being.

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 Study

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 7, 2010
Registry last updated
Nov 20, 2015

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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