Evidence map›Paper›PMID 36994841›Full record

Trial reportPalliative & supportive care2023

A pilot randomized study of a telephone-based cognitive-behavioral stress-management intervention to reduce distress in phase 1 oncology trial caregivers.

Alaina L Carr, Emily Bilenduke, Esmeralda Adolf, Elizabeth R Kessler, Joanna J Arch, Krista W Ranby, Kristin Kilbourn

Abstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Palliative & supportive care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Considering the caregiver in early-phase clinical trials: a review of trial protocols and consent forms.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Review
  4. Article
  5. Article
  6. 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

7 authors.

Alaina L CarrDepartment of Psychology, University of Colorado Denver, Denver, CO, USA.ORCID 0000-0002-9226-8439
Emily BilendukeDepartment of Psychology, University of Colorado Denver, Denver, CO, USA.
Esmeralda AdolfDepartment of Psychology, University of Colorado Denver, Denver, CO, USA.
Elizabeth R KesslerDivision of Medical Oncology, Department of Medicine, University of Colorado, Aurora, CO, USA.
Joanna J ArchDepartment of Psychology and Neuroscience, University of Colorado Boulder, Boulder, CO, USA.
Krista W RanbyDepartment of Psychology, University of Colorado Denver, Denver, CO, USA.
Kristin KilbournDepartment of Psychology, University of Colorado Denver, Denver, CO, USA.

Funding

Training Program in Cancer Population Science (CaPS)T32CA261787 · NCI · GEORGETOWN UNIVERSITY · PI Lucile L. Adams-Campbell, Suzanne C. O'Neill · 2021 to 2026
$1.1M
NCI NIH HHS T32 CA261787
6 · The paper itself

Abstract

objectivesCaregivers of adult phase 1 oncology trial patients experience high levels of distress and face barriers to in-person supportive care. The Phase 1 Caregiver LifeLine (P1CaLL) pilot study assessed the feasibility, acceptability, and general impact of an individual telephone-based cognitive behavioral stress-management (CBSM) intervention for caregivers of phase I oncology trial patients.

methodsThe pilot study involved 4 weekly adapted CBSM sessions followed by participant randomization to 4 weekly cognitive behavioral therapy sessions or metta-meditation sessions. A mixed-methods design used quantitative data from 23 caregivers and qualitative data from 5 caregivers to examine the feasibility and acceptability outcomes. Feasibility was determined using recruitment, retention, and assessment completion rates. Acceptability was assessed with self-reported satisfaction with program content and participation barriers. Baseline to post-intervention changes in caregiver distress and other psychosocial outcomes were assessed for the 8-session intervention.

resultsThe enrollment rate was 45.3%, which demonstrated limited feasibility based on an a priori criterion enrollment rate of 50%. Participants completed an average of 4.9 sessions, with 9/25 (36%) completing all sessions and an 84% assessment completion rate. Intervention acceptability was high, and participants found the sessions helpful in managing stress related to the phase 1 oncology trial patient experience. Participants showed reductions in worry and isolation and stress. SIGNIFICANCE OF

resultsThe P1CaLL study demonstrated adequate acceptability and limited feasibility and provided data on the general impact of the intervention on caregiver distress and other psychosocial outcomes. Caregivers of phase 1 oncology trial patients would benefit from supportive care services; a telephone-based intervention may have more utilization and thus make a larger impact.

Indexed as

Cognitive Behavioral TherapyNeoplasmsAdultCaregiversCognitionFeasibility StudiesHumansPilot ProjectsTelephoneCancerCaregiversPhase I trialsPilot projectsStress-management

Identifiers

PMID36994841
PMCPMC10544682

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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.