Evidence map›Paper›PMID 39695899›Full record

ArticlePilot and feasibility studies2024

A protocol for a feasibility study of Cognitive Bias Modification training (IVY) countering fatigue in people with breast cancer.

Jody A Geerts, Ester J M Siemerink, Falko F Sniehotta, Lucie J M Loman, Christina Bode, Marcel E Pieterse

Abstract read
In one paragraph

Article in Pilot and feasibility studies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
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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

6 authors.

Jody A GeertsDivision of Oncology, Department of Internal Medicine, ZGT Hospital, Almelo, the Netherlands. j.a.geerts@utwente.nl.ORCID http://orcid.org/0000-0002-8826-032X
Ester J M SiemerinkDivision of Oncology, Department of Internal Medicine, ZGT Hospital, Almelo, the Netherlands.
Falko F SniehottaDepartment of Public Health, Social and Preventive Medicine, Centre for Preventive Medicine and Digital Health (CPD), Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
Lucie J M LomanDutch Breast Cancer Association, [Borstkanker Vereniging Nederland], Utrecht, the Netherlands.
Christina BodeCentre for eHealth & Well-Being Research, Section Psychology, Health and Technology, University of Twente, Enschede, the Netherlands.
Marcel E PieterseCentre for eHealth & Well-Being Research, Section Psychology, Health and Technology, University of Twente, Enschede, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCancer-related fatigue (CRF) is the most prevalent, distressing, and quality of life disturbing symptom during and after cancer treatment for many cancer types including breast cancer. The experience and burden of this symptom can induce a cognitive bias towards fatigue or a fatigue-related self-image, which can further increase the fatigue symptoms and related behaviour. For this, a Cognitive Bias Modification (CBM) eHealth app (IVY) has been developed. The app aims to counter the fatigue-related self-image and to modify it towards vitality, which might translate to less experienced fatigue and more experienced vitality. This study aims to evaluate the feasibility of the IVY CBM training and the research design of a wait-list control trial. If feasibility is judged sufficient, the effectiveness of the CBM app will also be analyzed on (1) underlying mechanisms (cognitive fatigue bias), (2) symptom fatigue (self-reported fatigue and vitality), and (3) related behaviours (avoidance and all-or-nothing behaviour).

methodsThis feasibility study addresses individuals being treated for breast cancer receiving (neo)adjuvant treatment or metastatic care. The number of target participants is 120 (60 (neo)adjuvant, and 60 metastatic) patients. Both groups will be randomized with 30 people in the IVY treatment group and 30 people in the delayed treatment control group. All participants will receive the training via the IVY app, in which participants categorize words related to vitality with words related to 'I' and words related to fatigue with words related to 'other'. If feasibility is judged sufficient, the effects of the training will be explored on 3 levels: (1) self-identity bias, which will be measured with a short computer task based on the Implicit Association Test (IAT), (2) avoidance and all-or-nothing behaviour, and (3) fatigue and vitality levels, which will all be measured with questionnaires. DISCUSSION: This study aims to evaluate the feasibility of a larger-scale multi-centre Randomized Controlled Trial (RCT) to investigate a novel eHealth application and, if possible, to give indications on the effectiveness of this intervention to counter fatigue in individuals with breast cancer. Using the IVY CBM app requires very little effort, both in time and cognitive load, which could be especially beneficial for fatigue symptoms.

trial registrationRegistered at the Open Science Framework (OSF; https://osf.io/e85g7/ ) on October 20, 2023.

Indexed as

Breast cancerCancer-related fatigue (CRF)Cognitive bias modification (CBM)EHealth applicationVitality

Identifiers

PMID39695899
PMCPMC11654401

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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.