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ArticleDigital health

Cognitive-enhanced eHealth psychosocial stepped intervention for managing breast cancer-related cognitive impairment: Protocol for a randomized controlled trial.

Maria Serra-Blasco, Arnau Souto-Sampera, Joan C Medina, Aida Flix-Valle, Laura Ciria-Suarez, Alejandra Arizu-Onassis, Marina Ruiz-Romeo, Femke Jansen, Ana Rodríguez, Sonia Pernas and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Digital health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06103318 (Cognitive Rehabilitation and Psychosocial Intervention Through a Stepped Digital Ecosystem in Breast Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT06103318 naunknown statusnot on this map

Cognitive Rehabilitation and Psychosocial Intervention Through a Stepped Digital Ecosystem in Breast Cancer: A Randomized Clinical Trial.

TypeinterventionalSponsorInstitut Català d'OncologiaRan2024 to 2025Enrolled176ConditionsBreast Cancer, Cognitive DysfunctionArmsICOgnition
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
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

11 authors.

Maria Serra-BlascoICOnnecta't Digital Health Program, Catalan Institute of Oncology, Hospitalet del Llobregat, Spain.ORCID https://orcid.org/0000-0001-5793-9906
Arnau Souto-SamperaICOnnecta't Digital Health Program, Catalan Institute of Oncology, Hospitalet del Llobregat, Spain.
Joan C MedinaThe Bellvitge Biomedical Research Institute IDIBELL, Psychooncology and Digital Health Group, Hospitalet del Llobregat, Spain.ORCID https://orcid.org/0000-0002-4550-2157
Aida Flix-ValleICOnnecta't Digital Health Program, Catalan Institute of Oncology, Hospitalet del Llobregat, Spain.
Laura Ciria-SuarezICOnnecta't Digital Health Program, Catalan Institute of Oncology, Hospitalet del Llobregat, Spain.
Alejandra Arizu-OnassisThe Bellvitge Biomedical Research Institute IDIBELL, Psychooncology and Digital Health Group, Hospitalet del Llobregat, Spain.
Marina Ruiz-RomeoThe Bellvitge Biomedical Research Institute IDIBELL, Psychooncology and Digital Health Group, Hospitalet del Llobregat, Spain.
Femke JansenDepartment of Otolaryngology-Head and Neck Surgery, Amsterdam UMC, VUmc Cancer Center Amsterdam, Amsterdam, The Netherlands.
Ana RodríguezBreast Cancer Functional Unit, Catalan Institute of Oncology, Hospitalet del Llobregat, Spain.
Sonia PernasBreast Cancer Functional Unit, Catalan Institute of Oncology, Hospitalet del Llobregat, Spain.
Cristian Ochoa-ArnedoICOnnecta't Digital Health Program, Catalan Institute of Oncology, Hospitalet del Llobregat, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Breast cancer often leads to cancer-related cognitive impairment (CRCI), which includes both objective and subjective cognitive deficits. While psychosocial interventions benefit quality of life and distress reduction, their impact on cognitive deficits is uncertain. This study evaluates the integration of a cognitive module into a digital psychosocial intervention for breast cancer patients. Methods: In this randomized controlled trial (RCT), 88 recently diagnosed breast cancer (BC) patients will receive the ICOnnecta't program (control group) - a digital stepped intervention addressing a variety of psychosocial needs. The experimental group ( Results: The cognitive module includes three levels. The first level contains a cognitive screening using FACT-Cog Perceived Cognitive Impairment (PCI). Patients with PCI <54 progress to a cognitive psychoeducational campus (Level 2) with content on cognitive education, behavioural strategies and mindfulness. Patients with persistent or worsened PCI (≥6) after 3 months move to Level 3, an online cognitive training through CogniFit software delivered twice a week over 12 weeks. Conclusions: This study assesses whether integrating a cognitive module into a digital psychosocial intervention improves objective and subjective cognition in breast cancer patients. Secondary outcomes explore cognitive improvement's impact on psychosocial variables. The research will contribute to testing efficacious approaches for detecting and addressing cognitive dysfunction in breast cancer patients. Trial registration: ClinicalTrials.gov, NCT06103318. Registered 26 October 2023, https://classic.clinicaltrials.gov/ct2/show/NCT06103318?term=serra-blasco&draw=2&rank=4.

Indexed as

cancer related cognitive dysfunctiondigital clinical trialsdigital healtheHealthmHealthneuropsychologyoncologypsycho-oncologywellbeingwomen's health

Identifiers

PMID39070895
PMCPMC11273701

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Registered trials

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.