Evidence map›Paper›PMID 33148357›Full record

Trial reportPalliative & supportive care2020

Current measures of distress may not account for what's most important in existential care interventions: Results of the outlook trial.

Karen E Steinhauser, Karen M Stechuchak, Katherine Ramos, Joseph Winger, James A Tulsky, Maren K Olsen

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Palliative & supportive care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Karen E SteinhauserCenter of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, VA.ORCID 0000-0002-3084-711X
Karen M StechuchakCenter of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, VA.
Katherine RamosCenter of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, VA.
Joseph WingerDepartment of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.ORCID 0000-0001-6278-2560
James A TulskyDepartment of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA.
Maren K OlsenCenter of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, VA.

Funding

Uncertainty management in patients awaiting liver transplantP01NR010948 · NINR · DUKE UNIVERSITY · PI TULSKY, JAMES A. · 2008 to 2012
$3.3M
Trajectories of Serious Illness: Patients and CaregiversR01NR008249 · NINR · DUKE UNIVERSITY · PI TULSKY, JAMES A. · 2003 to 2007
$3.1M
HSRD VA I01 HX002037NINR NIH HHS P01 NR010948NINR NIH HHS R01 NR008249
6 · The paper itself

Abstract

objectiveCompare the efficacy of two interventions addressing emotional and existential well-being in early life-limiting illness.

methodPrimary trial analysis (n = 135) included patients with advanced cancer, congestive heart failure, or end-stage renal disease; Arm 1 received the Outlook intervention, addressing issues of life completion and preparation, and Arm 2 received relaxation meditation (RM). Primary outcomes at five weeks (primary endpoint) and seven weeks (secondary): completion and preparation (QUAL-E); secondary outcomes: anxiety (POMS) quality of life (FACT-G) and spiritual well-being (FACIT-Sp) subscales of faith, meaning, and peace.

resultsAverage age was 62; 56% were post-high school-educated, 54% were married, 52% white, 44% female, and 70% had a cancer diagnosis. At baseline, participants demonstrated low levels of anxiety (<5 on POMS subscale) and depression (<10 on CESD) relative to population norms. Results of the primary analysis revealed no significant differences in mean Preparation by treatment arm at five weeks (14.4 Outlook vs. 14.8 RM; between-group difference -0.4 [95% CI, -1.6, 0.8], p = 0.49) or seven weeks (15.2 vs.15.4; between-group difference -0.2 [95% CI, -1.5, 1.0], p = 0.73). There were also no significant differences in mean Life Completion by treatment arm between five weeks (26.6 Outlook vs. 26.3 RM; between-group difference 0.2 [95% CI, -1.2, 1.7], p = 0.76) or seven weeks (26.5 vs. 27.5; between-group difference -1.0 [95% CI, -2.7, 0.7], p = 0.23). Compared to RM, Outlook participants did not have significant differences over time in the secondary outcomes of overall quality of life, anxiety, depression, FACT-G subscales, and FACIT-Sp subscales. DISCUSSION: In early-stage life-limiting illness, Outlook did not demonstrate a significant difference in primary or secondary outcomes relative to RM. Results underscore the importance of pre-screening for distress. Qualitatively, Outlook participants were able to express suppressed emotions, place illness context, reflect on adaptations, and strengthen identity. Screening for distress and identifying specified measures of distress, beyond anxiety and depression, is essential in our ability to adequately assess the multi-dimensional mechanisms that decrease existential suffering.

Indexed as

Psychological DistressAgedExistentialismFemaleHumansInterviews as TopicMaleMiddle AgedPsychometricsQuality of LifeExistential needsRandomized trialSpiritual care

Identifiers

PMID33148357
PMCPMC8943908

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.