Evidence map›Paper›PMID 39881331›Full record

ArticleTrials2025

Statistical analysis plan for a pragmatic randomised controlled trial comparing enhanced acceptance and commitment therapy plus ( +) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors' Rehabilitation Evaluation after CANcer (SURECAN) trial.

Clare Robinson, Trudie Chalder, Paul McCrone, Olivier Quintin, Evdoxia Gkaintatzi, Imran Khan, Stephanie J C Taylor, SURECAN GROUP

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Clare RobinsonCentre for Evaluation and Methods, Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.
Trudie ChalderInstitute of Psychiatry, Psychology and Neuroscience, King's College London, De'Crespigny Park, London, UK. trudie.chalder@kcl.ac.uk.ORCID http://orcid.org/0000-0003-0775-1045
Paul McCroneInstitute for Lifecourse Development, University of Greenwich, London, UK.
Olivier QuintinCentre for Evaluation and Methods, Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.
Evdoxia GkaintatziInstitute for Lifecourse Development, University of Greenwich, London, UK.
Imran KhanLondon Centre for Primary Care, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Stephanie J C TaylorLondon Centre for Primary Care, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
SURECAN GROUP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of the SURECAN trial is to evaluate a person-centred intervention, based on Acceptance and Commitment Therapy (ACT Plus ( +)), for people who have completed treatment for cancer with curative intent, but are experiencing poor quality of life. We present the statistical analysis plan for assessing the effectiveness and cost-effectiveness of the intervention in improving quality of life 1 year post randomisation. METHODS AND

designSURECAN is a multi-centre, pragmatic, two-arm, partially clustered randomised controlled superiority trial comparing the effectiveness of ACT + added to usual care with usual aftercare. The target sample size is 344 (172 per arm), randomised centrally in a 1:1 ratio.

resultsThe primary outcome is the total score of the Functional Assessment of Cancer Therapy scale-General (FACT-G) at 52 weeks, analysed using a partially nested mixed-effects model with heteroskedastic error terms. Secondary outcomes include scores at 16 and 52 weeks: FACT-G subscales; Fear of Cancer Recurrence Inventory (FCR4); positive and negative Impact of Cancer scales (IOCv2); Hospital Anxiety and Depression scale (HADS); Chalder Fatigue Scale (CFQ); and physical activity, measured on a modified version of the Godin scale. Health economic analyses will determine the incremental cost-effectiveness ratio (ICER) in terms of quality-adjusted life years (QALYs) derived from the Euroqol 5-Dimension 5-Level (EQ-5D-5L) compared to usual care at 52 weeks. DISCUSSION: This manuscript is the statistical analysis plan (SAP) and economic evaluation for the SURECAN trial. Any exploratory or post hoc analyses will be identified as such in the respective analysis report.

trial registrationThe trial was prospectively registered. ISRCTN: ISRCTN67900293. Registered on 09 December 2019.

Indexed as

Acceptance and Commitment TherapyAftercareCancer SurvivorsNeoplasmsCost-Benefit AnalysisData Interpretation, StatisticalEquivalence Trials as TopicHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality of LifeTreatment OutcomeAcceptance and commitment therapyCancer survivorCost-effectivenessPartially clustered designPragmatic trialQuality of lifeStatistical analysis plan

Identifiers

PMID39881331
PMCPMC11780776

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LicenceCC BY-NC-ND
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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.