CancerNCT00784095
Outlook Quality of Life Intervention
A study testing Life completion and preparation in people with Cancer and Congestive Heart Failure, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Life completion and preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with advanced cancer, CHF or COPD.
Who cannot join
- Cognitive impairment, inability to speak, non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center HSR&D COE
Durham, North Carolina, 27705
About this study
Official title: Outlook: An Intervention to Improve Quality of Life in Serious Illness
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.
Read the detailed description
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.
- Being tested
- Life completion and preparation, Attention Control
- Keywords
- quality of life
- Medical subject headings
- Neoplasms, Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life completion and preparationOther
Subjects will discuss life review, issues of forgiveness and heritage and legacy.
Attention ControlOther
Subjects will listen to a non-guided relaxation CD.
| Study group | Role | What they receive |
|---|---|---|
| Preparation and Completion | Experimental | Subjects in the first group ("treatment") met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy. Receives: Other: Life completion and preparation |
| Attention Control | Active comparator | The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD. Receives: Other: Attention Control |
| True Control | No intervention | Subjects in the third group ("true control") were exposed to no intervention or attention control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life - Preparation
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.
Measured: Baseline, 6 and 8 week follow up
QUAL-E Completion Sub-scale
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.
Measured: Baseline, 6 and 8 week follow up
Secondary outcomes (3)
Functional Status ADL
Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.
Measured: Baseline, 6 and 8 week follow ups
Center for Epidemiology Studies - Depression Scale (CES-D)
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.
Measured: Baseline, 6 and 8 week follow up
POMS Anxiety Sub-scale
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.
Measured: Baseline, 6 and 8 week follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Karen E. Steinhauser, PhD, Principal investigator, Durham VA Medical Center HSR&D COE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784095
- Sponsor's protocol ID
- IAD 07-162
- Status last verified
- Mar 2016
- First submitted
- 30 Oct 2008
- Last updated
- 22 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sautter JM, Tulsky JA, Johnson KS, Olsen MK, Burton-Chase AM, Lindquist JH, Zimmerman S, Steinhauser KE. Caregiver experience during advanced chronic illness and last year of life. J Am Geriatr Soc. 2014 Jun;62(6):1082-90. doi: 10.1111/jgs.12841. Epub 2014 May 6.
PubMed 24803020
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. 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
- NCT00784095
- Acronym / sponsor ID
- IAD 07-162
- Keywords
- quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Dec 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 3 Nov 2008 (estimated)
- Results
- Posted 22 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preparation and Completion | Experimental | Other: Life completion and preparationSubjects in the first group ("treatment") met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy. |
| Attention Control | Active comparator | Other: Attention ControlThe subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD. |
| True Control | No intervention | –Subjects in the third group ("true control") were exposed to no intervention or attention control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with advanced cancer, CHF or COPD.
Key exclusion criteria (1 listed)
- Cognitive impairment, inability to speak, non-English speaking
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 |
|---|---|---|
| Life completion and preparationSubjects will discuss life review, issues of forgiveness and heritage and legacy. | Other | Preparation and Completion |
| Attention ControlSubjects will listen to a non-guided relaxation CD. | Other | Attention Control |
Primary outcome
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.
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.
3 secondary outcomes
Functional Status ADL
Time frame: Baseline, 6 and 8 week follow ups
Center for Epidemiology Studies - Depression Scale (CES-D)
Time frame: Baseline, 6 and 8 week follow up
POMS Anxiety Sub-scale
Time frame: Baseline, 6 and 8 week follow ups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24803020Sautter JM, Tulsky JA, Johnson KS, Olsen MK, Burton-Chase AM, Lindquist JH, Zimmerman S, Steinhauser KE. Caregiver experience during advanced chronic illness and last year of life. J Am Geriatr Soc. 2014 Jun;62(6):1082-90. doi: 10.1111/jgs.12841. Epub 2014 May 6.
- Individual participant dataSharing planned: No
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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 E. Steinhauser, PhD principal investigator
Durham VA Medical Center HSR&D COE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life completion and preparation in people with Cancer and Congestive Heart Failure, run by VA Office of Research and Development 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 1 inclusion and 1 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 22 Mar 2016. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quality of Life - Preparation (time frame: Baseline, 6 and 8 week follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00784095, which also lists 1 linked publication.
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 22 Mar 2016.