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eHealth Interventions for Breast Cancer Cognitive Impairment

NCT06103318 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2024-03-06

No results posted yet for this study

Summary

This study investigates the effectiveness of integrating a cognitive rehabilitation module into a digital psychosocial intervention for recently diagnosed breast cancer patients. The trial involves 176 participants, with one group receiving the ICOnnecta't program (stepped psychosocial intervention) and the other receiving ICOnnecta't with an additional cognitive stepped intervention called ICOgnition. ICOgnition has three levels of intervention including cognitive screening and monitoring, psychoeducation, and online cognitive training. Assessments of the study outcomes will be conducted at baseline, 3 months, 6 months, and 1 year, measuring cognitive functioning, emotional well-being, medication adherence, work functioning, and overall quality of life. The study aims to improve understanding of efficient ways to detect cognitive dysfunction in cancer patients and assess the benefits and feasibility of this early intervention for managing cognitive impairment in breast cancer patients.

Conditions

Interventions

BEHAVIORAL

ICOgnition

The ICOgnition intervention for breast cancer patients consists of three levels: Level 1: Monthly assessments using FACT-Cog PCI and Cognifit. Scores \<54 (PCI) or ≤250 (Cognifit) escalate to Level 2. Level 2: Specialized content includes Cognitive Psychoeducation, validating experiences and improving health literacy; Behavioral Guidance, offering practical strategies for daily tasks; and Embracing Cognitive Deficits, promoting self-compassion and acceptance through mindfulness and metaphors. Level 3: Online cognitive training focuses on enhancing cognitive skills through gaming exercises, completing the comprehensive intervention approach.

Sponsors & Collaborators

  • Institut d'Investigació Biomèdica de Bellvitge

    collaborator OTHER

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • Institut Català d'Oncologia

    lead OTHER

Principal Investigators

  • Cristian Ochoa Arnedo, PhD · Institut Català d'Oncologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2025-04-07
Completion
2025-09-07

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06103318 on ClinicalTrials.gov