Evidence map›Paper›PMID 34787471›Full record

Trial reportChronic illness2023

Burden of cancer trial participation: A qualitative sub-study of the INTERIM feasibility RCT.

Chidiebere Nwolise, Pippa Corrie, Ray Fitzpatrick, Avinash Gupta, Crispin Jenkinson, Mark Middleton, Rubeta Matin

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Chronic illness, 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
2.4field-weighted citation impact, top 8% 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.

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, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  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 at 5 institutions in 1 country.

Chidiebere NwoliseHealth Services Research Unit, Nuffield Department of Population Health, 6396University of Oxford, Oxford, UK.ORCID 0000-0002-5510-1103
Pippa Corrie2153Cambridge Cancer Centre, 2153Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.
Ray FitzpatrickHealth Services Research Unit, Nuffield Department of Population Health, 6396University of Oxford, Oxford, UK.
Avinash Gupta5294The Christie NHS Foundation Trust, Manchester, UK.
Crispin JenkinsonHealth Services Research Unit, Nuffield Department of Population Health, 6396University of Oxford, Oxford, UK.ORCID 0000-0002-3692-0779
Mark Middleton3533University of Oxford Department of Oncology, 3533Cancer Research UK Oxford Centre, Oxford, UK.
Rubeta MatinDermatology Department, 99060Churchill Hospital, Oxford, UK.ORCID 0000-0002-9695-5412
National Institute for Health Research · GBUniversity of Oxford · GBCambridge University Hospitals NHS Foundation Trust · GBChurchill Hospital · GBThe Christie NHS Foundation Trust · GB

Funding

Cancer Research UK 24579
6 · The paper itself

Abstract

objectiveA qualitative sub-study was carried out within a larger phase II feasibility trial, to identify and describe the burden experienced by advanced melanoma patients participating in a clinical trial and the factors affecting their capacity to cope with the burden.

methodsSemi-structured interviews were conducted with fourteen patients with advanced melanoma recruited from National Health Service hospitals in the United Kingdom. Qualitative analysis was undertaken using a framework analysis approach. Normalisation process theory was applied to the concept of research participation burden in order to interpret and categorise findings.

resultsBurdens of participation were identified as arising from making sense of the trial and treatment; arranging transport, appointment and prescriptions; enacting management strategies and enduring side effects; reflecting on trial documents and treatment efficacy, and emotional and mental effects of randomisation and treatment side effects. Factors reported as influencing capacity include personal attributes and skills, physical and cognitive abilities and support network. DISCUSSION: This is the first study to highlight the substantial burden faced by patients with advanced melanoma in a clinical trial and factors that may lessen or worsen the burden. Consideration of identified burdens during trial design and execution will reduce the burden experienced by research participants.

Indexed as

MelanomaState MedicineFeasibility StudiesHumansQualitative ResearchTreatment Outcomecancer trial participationpatient capacityqualitativeResearch burdentreatment burden

Identifiers

PMID34787471
PMCPMC9841458
OpenAlexW3212555814

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.