Evidence map›Paper›PMID 37301841›Full record

Trial reportBMC cancer2023

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial.

Shenmeng Xu, Xianming Tan, Chunxuan Ma, Rebecca S McElyea, Karl Shieh, Angela M Stover, Angela Smith, Karyn Stitzenberg, Ethan Basch, Lixin Song

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04492007 (Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
4.4field-weighted citation impact, top 5% of its field
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.

NCT04492007 nacompletednot on this map

Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)

TypeinterventionalSponsorUNC Lineberger Comprehensive Cancer CenterRan2020 to 2021Enrolled46ConditionsColorectal Cancer, Bladder Cancer, Ovarian Cancer, Cervical CancerArmsPatient-Reported Outcomes-Informed Symptom Management System (PRISMS)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

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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

10 authors at 3 institutions in 1 country.

Shenmeng XuSchool of Nursing, University of North Carolina, Chapel Hill, North Carolina, USA.
Xianming TanUNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Chunxuan MaSchool of Nursing, University of North Carolina, Chapel Hill, North Carolina, USA.
Rebecca S McElyeaSchool of Nursing, University of North Carolina, Chapel Hill, North Carolina, USA.
Karl ShiehSchool of Nursing, University of North Carolina, Chapel Hill, North Carolina, USA.
Angela M StoverUNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Angela SmithUNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Karyn StitzenbergUNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Ethan BaschUNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Lixin SongSchool of Nursing, University of North Carolina, Chapel Hill, North Carolina, USA. lsong@unc.edu.
UNC Lineberger Comprehensive Cancer CenterUniversity of North Carolina at Chapel Hill · USUniversity of North Carolina Health Care · US

Funding

Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
NCI NIH HHS UG1 CA189823
6 · The paper itself

Abstract

backgroundCancer patients with newly created ostomies face complications that reduce quality of life (QOL) and increase morbidity and mortality. This proof-of-concept study examined the feasibility, usability, acceptability, and initial efficacy of an eHealth program titled the "Patient Reported Outcomes-Informed Symptom Management System" (PRISMS) during post-ostomy creation care transition.

methodsWe conducted a 2-arm pilot randomized controlled trial among 23 patients who received surgical treatment with curative intent for bladder and colorectal cancer and their caregivers. After assessing QOL, general symptoms, and caregiver burden at baseline, participants were randomly assigned to PRISMS (n = 16 dyads) or usual care (UC) (n = 7 dyads). After a 60-day intervention period, participants completed a follow-up survey and post-exit interview. We used descriptive statistics and t-tests to analyze the data.

resultsWe achieved an 86.21% recruitment rate and a 73.91% retention rate. Among the PRISMS participants who used the system and biometric devices (n = 14, 87.50%), 46.43% used the devices for ≥ 50 days during the study period. Participants reported PRISMS as useful and acceptable. Compared to their UC counterparts, PRISMS patient social well-being scores decreased over time and had an increased trend of physical and emotional well-being; PRISMS caregivers experienced a greater decrease in caregiver burden.

conclusionsPRISMS recruitment and retention rates were comparable to existing family-based intervention studies. PRISMS is a useful and acceptable multilevel intervention with the potential to improve the health outcomes of cancer patients needing ostomy care and their caregivers during post-surgery care transition. A sufficiently powered RCT is needed to test its effects.

trial registrationClinicalTrial.gov ID: NCT04492007. Registration date: 30/07/2020.

Indexed as

NeoplasmsOstomyTelemedicineCaregiversFeasibility StudiesHumansPilot ProjectsQuality of LifeCancerComplicationeHealthOstomyQuality of lifeRandomized controlled trialSelf-management

Identifiers

PMID37301841
PMCPMC10257159
OpenAlexW4380153184

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.