NeoplasmsNCT00939146
Outlook: An Intervention to Improve Quality of Life in Serious Illness
A study testing Outlook Intervention in people with Neoplasms and Pulmonary Disease, Chronic Obstructive, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Pulmonary Disease, Chronic Obstructive, Heart Failure
- What is being tested?
- Outlook Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
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.
Read the 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.
- Being tested
- Outlook Attention Control, Outlook Intervention
- Keywords
- self management, quality of life, end of life
- Medical subject headings
- Neoplasms, Pulmonary Disease, Chronic Obstructive, Heart Failure, Kidney Diseases, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outlook Attention ControlOther
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 InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Outlook Attention Control | Other | 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. Receives: Other: Outlook Attention Control |
| Outlook Intervention | Other | 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. Receives: Other: Outlook Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
QUAL-E subscale describing preparation for death (Quality of Life at End of Life, Steinhauser et al. 2004)
Measured: Eight weeks
Secondary outcomes (1)
Remaining subscales of the QUAL-E instrument (Quality of Life at End of Life, Steinhauser et al. 2004)
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startFeb 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Karen Steinhauser, PhD, Principal investigator, Duke UniversityJames A Tulsky, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939146
- Sponsor's protocol ID
- Pro00011193
- Other IDs
- 1P01NR010948-01
- Status last verified
- Feb 2014
- First submitted
- 10 Jul 2009
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outlook: An Intervention to Improve Quality of Life in Serious Illness
- ClinicalTrials.gov ID
- NCT00939146
- Acronym / sponsor ID
- Pro00011193
- Keywords
- self management, quality of life, end of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Feb 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outlook Attention Control | Other | Other: Outlook Attention ControlSubjects 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 | Other | Other: Outlook InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outlook Attention ControlSubjects 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 |
| Outlook InterventionThe 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 |
Primary outcome
QUAL-E subscale describing preparation for death (Quality of Life at End of Life, Steinhauser et al. 2004)
Time frame: Eight weeks
1 secondary outcome
Remaining subscales of the QUAL-E instrument (Quality of Life at End of Life, Steinhauser et al. 2004)
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Steinhauser, PhD principal investigator
Duke University
James A Tulsky, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outlook Intervention in people with Neoplasms and Pulmonary Disease, Chronic Obstructive, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QUAL-E subscale describing preparation for death (Quality of Life at End of Life, Steinhauser et al. 2004) (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2014.