Evidence map›Paper›PMID 40088188›Full record

Trial reportPsycho-oncology2025

Efficacy and Budget Impact of a Tailored Psychological Intervention Program Targeting Cancer Patients With Adjustment Disorder: A Randomised Controlled Trial.

K Holtmaat, F E van Beek, L M A Wijnhoven, J A E Custers, E J Aukema, S E J Eerenstein, I M van Oort, J E M Werner, J A Wegdam, I L E Jansen-Engelen and 14 more

Erratum issuedAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Psycho-oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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

5 · Who and what money

Authors and funding

24 authors.

K HoltmaatDepartment of Clinical, Neuro and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-1067-3327
F E van BeekDepartment of Clinical, Neuro and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
L M A WijnhovenDepartment of Medical Psychology, Research Institute for Medical Innovation, Radboudumc Nijmegen, Nijmegen, the Netherlands.ORCID 0000-0002-4234-4704
J A E CustersDepartment of Medical Psychology, Research Institute for Medical Innovation, Radboudumc Nijmegen, Nijmegen, the Netherlands.ORCID 0000-0002-1573-6040
E J AukemaCentre for Psycho-Oncology, Ingeborg Douwes Centrum, Amsterdam, the Netherlands.
S E J EerensteinTreatment and Quality of Life, Cancer Center Amsterdam, Amsterdam, the Netherlands.
I M van OortDepartment of Urology, Radboudumc Nijmegen, Nijmegen, the Netherlands.
J E M WernerDepartment of Surgery Oncology, Radboudumc Nijmegen, Nijmegen, the Netherlands.
J A WegdamDepartment of Surgery, Elkerliek Hospital, Helmond, the Netherlands.
I L E Jansen-EngelenDepartment of Surgery, St. Jans Gasthuis Hospital, Weert, the Netherlands.
I H J T de HinghDepartment of Surgery, Catharina Hospital, Eindhoven, the Netherlands.
S VerheulDepartment of Medical Psychology, CWZ Nijmegen, Nijmegen, the Netherlands.
D T van der BeekDepartment of Psychology and Psychiatry, Haga Hospital, The Hague, the Netherlands.
G WekkingPsychologists Practice Wekking, Harderwijk, the Netherlands.
I SteggerdaBloem Psychology, Voorburg, the Netherlands.
V M H CoupéDepartment of Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
N HorevoortsDepartment of Medical and Clinical Psychology, Tilburg University, Tilburg, the Netherlands.
A M de KorteDepartment of Medical and Clinical Psychology, Tilburg University, Tilburg, the Netherlands.ORCID 0000-0002-9201-9176
C LammensThe Netherlands Comprehensive Cancer Organization, Utrecht, the Netherlands.
B I Lissenberg-WitteDepartment of Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
B H de RooijThe Netherlands Comprehensive Cancer Organization, Utrecht, the Netherlands.ORCID 0000-0002-0172-0857
J B PrinsDepartment of Medical Psychology, Research Institute for Medical Innovation, Radboudumc Nijmegen, Nijmegen, the Netherlands.ORCID 0000-0001-5720-6091
I M Verdonck-de LeeuwDepartment of Clinical, Neuro and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
F JansenTreatment and Quality of Life, Cancer Center Amsterdam, Amsterdam, the Netherlands.

Funding

ZonMw 856001005
6 · The paper itself

Abstract

backgroundEvidence on the efficacy of psychological interventions targeting cancer patients diagnosed with an adjustment disorder is scarce.

aimsThis study aimed to investigate the efficacy and budget impact of a tailored psychological intervention program (AD-program) targeting cancer patients with adjustment disorder (AD).

methodsPatients (n = 59) were randomised to the intervention or control group. The AD-program consisted of three modules: psychoeducation (1-4 sessions) and two additional modules (maximum of 6 sessions per module) provided when needed. The primary outcome was psychological distress (HADS). Secondary outcomes were mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). Measures were completed at baseline and 3 and 6 months after randomisation. The budget impact analyses were based on the population size, the costs of the AD-program, and other costs potentially affected by the AD-program.

resultsThe mean psychological distress score in the intervention group (n = 33) decreased over time (M = 19.2 at T0, M = 15.6 at T6). This decrease was not significantly different from decrease in the control condition (n = 26, M = 17.5 at T0, M = 15.9 at T6, p > 0.05). Also, there were no significant differences between the two conditions on the secondary outcomes. The budget impact of the AD-program was estimated at 7-28 million euros per year (to treat 14,430 patients).

conclusionsThe effect of the AD-program was not statistically significant in this RCT. Limitations include that this study was underpowered due to recruitment difficulties during the COVID-19 pandemic. More research on the efficacy and implementation of the AD-program is warranted.

trial registrationNetherlands Trial Register identifier: NL7763. Registered on 3 June 2019.

Indexed as

Adjustment DisordersNeoplasmsPsychosocial InterventionAdaptation, PsychologicalAdultAgedBudgetsCOVID-19FemaleHumansMaleMiddle AgedPsychological DistressQuality of LifeStress, PsychologicalTreatment Outcomeadjustment disorderanxietycancercost‐benefit analysisdepressionhealth‐related quality of lifeoncologypsychological distresspsychological interventionrandomised controlled trial

Identifiers

PMID40088188
PMCPMC11910135

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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.