Evidence map›Paper›PMID 41513883›Full record

ArticleTherapeutic innovation & regulatory science2026

Patient-Perceived Overall Side Effect Bother at and After Cancer Treatment Discontinuation: An Analysis Using Commercial Cancer Trial Data.

Jessica Roydhouse, Monique Breslin, Anne Zola, Ethan Basch, Melanie Calvert, David Cella, Mary Lou Smith, Gita Thanarajasingam, John Devin Peipert

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PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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.

Jessica RoydhouseMenzies Institute for Medical Research, University of Tasmania, 15-17 Liverpool Street, Hobart, TAS, 7000, Australia. jessica.roydhouse@utas.edu.au.
Monique BreslinMenzies Institute for Medical Research, University of Tasmania, 15-17 Liverpool Street, Hobart, TAS, 7000, Australia.
Anne ZolaKellogg School of Management, Northwestern University, Evanston, IL, USA.
Ethan BaschUniversity of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Melanie CalvertCentre for Patient-Reported Outcomes Research, Birmingham Health Partners Centre for Regulatory Science and Innovation, National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre and NIHR Blood and Transplant Research Unit in Precision Cellular Therapeutics, University of Birmingham, Edgbaston, Birmingham, UK.
David CellaFeinberg School of Medicine, Northwestern University, Evanston, IL, USA.
Mary Lou SmithResearch Advocacy Network, Plano, TX, USA.
Gita ThanarajasingamDivision of Hematology, Mayo Clinic, Rochester, MN, USA.
John Devin PeipertCentre for Patient-Reported Outcomes Research, Birmingham Health Partners Centre for Regulatory Science and Innovation, National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, University of Birmingham, Edgbaston, Birmingham, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere is widespread interest among patients, clinicians, regulators and other constituents in post-treatment patient-reported cancer data. Side effect bother is a patient-reported outcome (PRO) that can capture an important aspect of tolerability. In this study, we examined side effect bother at cancer treatment discontinuation and post-discontinuation in commercial cancer trials. We sought to understand completion rates, the extent of bother and its association with other PROs. MATERIALS AND

methodsData were evaluated from three trials in patients with solid tumours (renal cell carcinoma and breast cancer). Side effect bother was measured with the Functional Assessment of Chronic Illness Therapy (FACIT) GP5 item. Symptom items were drawn from FACIT and function items were drawn from the EQ-5D-3L. FACIT items, including the GP5, are on a 0-4 scale (higher = worse symptoms/bother), and were dichotomised as 0-1 ("low") vs 2-4 ("moderate"). EQ-5D-3L items were characterised as no problems (1) and some problems (2-3). Descriptive and correlation analyses were conducted separately for each trial.

resultsAmong patients who received treatment, completion rates at discontinuation for most items were at least 70%, and 52% to 78% at follow up. More than 20% of patients had high side effect bother at and after discontinuation, and similar percentages were seen for symptom items and functioning problems. GP5 and most items were at least somewhat correlated (≥ 0.2 in nearly all evaluations). DISCUSSION AND

conclusionsPersistent side effect bother and symptomatic and functional detriments at and after discontinuation suggest capturing this information post-treatment can inform understanding of tolerability, particularly with improved PRO completion.

Indexed as

Adverse eventCancerClinical trialPatient-reported outcomeSide effectTolerability

Identifiers

PMID41513883
PMCPMC12945917

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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.