Evidence map›Paper›PMID 34033228›Full record

Trial reportCancer medicine2021

A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials.

Michelle Treasure, Barbara Daly, Shufen Cao, Pingfu Fu, Augustine Hong, Elizabeth Weinstein, Jessica Surdam, Neal J Meropol, Afshin Dowlati

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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

8 citing papers in PubMed.

  1. Associations of symptom burden with patient-reported outcomes and clinical outcomes among early phase cancer clinical trial participants.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  2. Use of supportive care services and advance care planning among early phase oncology clinical trial participants.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  3. Article
  4. Article
  5. Stakeholder perspectives on the role of caregivers in cancer clinical trial decision-making: results of a qualitative study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  6. Article
  7. Reflections on the opportunities and challenges of applying experience-based co-design (EBCD) to phase 1 clinical trials in oncology.Health expectations : an international journal of public participation in health care and health policy · 2024
    Article
  8. 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

9 authors.

Michelle TreasureDepartment of Medicine, University Hospitals Cleveland Medical Center, Seidman Cancer Center and Case Western Reserve University, Cleveland, OH, USA.ORCID 0000-0002-7536-6926
Barbara DalyFrances Payne School of Nursing, Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA.
Shufen CaoDepartment of Population and Quantitative Health Sciences, Case Western Reserve University, Case Comprehensive Cancer Center, Cleveland, OH, USA.
Pingfu FuDepartment of Population and Quantitative Health Sciences, Case Western Reserve University, Case Comprehensive Cancer Center, Cleveland, OH, USA.
Augustine HongDepartment of Medicine, University Hospitals Cleveland Medical Center, Seidman Cancer Center and Case Western Reserve University, Cleveland, OH, USA.
Elizabeth WeinsteinDepartment of Medicine, University Hospitals Cleveland Medical Center, Seidman Cancer Center and Case Western Reserve University, Cleveland, OH, USA.
Jessica SurdamUniversity Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA.
Neal J MeropolDepartment of Medicine, University Hospitals Cleveland Medical Center, Seidman Cancer Center and Case Western Reserve University, Cleveland, OH, USA.
Afshin DowlatiDepartment of Medicine, University Hospitals Cleveland Medical Center, Seidman Cancer Center and Case Western Reserve University, Cleveland, OH, USA.

Funding

Conquer Cancer Foundation Young Investigator Award 8431University Hospitals Seidman Cancer Center - Lucile and Robert Gries Early Phase Therapeutics Program Endowment
6 · The paper itself

Abstract

purposePatients enrolled in Phase 1 clinical trials have typically exhausted standard therapies and often are choosing between a clinical trial and hospice care. Significant symptom burden can result in early trial discontinuation and confound trial outcomes. This study aimed to examine differences in study duration, symptom burden, adverse events (AE), and quality of life (QOL) between those receiving structured palliative care versus usual supportive care. PATIENTS AND

methodsSixty-eight patients enrolled in phase 1 clinical trials and 39 of their CGs were randomly assigned to receive structured palliative care or usual supportive care. Patient QOL was measured monthly using the Functional Assessment of Cancer Therapy and Memorial Symptom Assessment Scale. The Quality of Life in Life-Threatening Illness-Family Care Version and Caregiver Reaction Assessment were used for CGs. AEs and use of palliative care resources were compared between arms.

resultsMean duration of the phase 1 study was 142 days in the palliative care arm versus 116 days in the usual care arm (p = 0.55). Although not statistically significant, patients in the palliative care arm experienced fewer AEs and better QOL, as did their CGs, compared to those receiving usual care.

conclusionsPhase 1 patients and their CGs have physical and psychosocial needs warranting palliative care services. Results suggest that structured palliative care is associated with the increased duration of the study and improved patient and CG QOL.

Indexed as

Clinical Trials, Phase I as TopicAdultAgedAged, 80 and overCaregiversFemaleHumansMaleMiddle AgedNeoplasmsPalliative CareQuality of LifeSex FactorsSymptom AssessmentTime Factors

Identifiers

PMID34033228
PMCPMC8267138

What OpenQuestion holds

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Registered trials

None linked

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.