Clinical trial · Interventional
eHealth Interventions for Breast Cancer Cognitive Impairment
Cognitive Rehabilitation and Psychosocial Intervention Through a Stepped Digital Ecosystem in Breast Cancer: A Randomized Clinical Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cognitive Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICOgnition | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ICOnnectat
- description
- ICOnnecta't is a stepped-care digital intervention tailored to breast cancer patients' psychosocial needs. It consists of four levels: 1. rst level. Psychosocial Screening and Monitoring: Patients assess their emotional distress and symptoms; consultations with a health psychologist are scheduled if distress is high. 2. nd level. Campus (Psychoeducation and Health Education): Patients access educational resources covering medical information, emotional well-being, relationships, and healthy habits. 3. r level. Community Psychosocial Support: Patients engage in an online community to share experiences and concerns under supervision. 4. th level. Online Group Psychotherapy: Patients participate in online group psychotherapy sessions led by a psycho-oncology specialist.
- interventionNames
- Behavioral: ICOgnition
- type
- EXPERIMENTAL
- label
- ICOgnition
- description
- ICOgnition enhances ICOnnecta't with a Cognitive Module, following the same stepped-structure and specifically addressing cognitive deficits in breast cancer patients. It includes: 1. rst level. Cognitive Screening and Monitoring: Patients complete monthly cognitive assessments and online objective cognitive tests. If scores indicate impairment, they advance to the next level. 2. nd level. Cognitive Psychoeducational Campus: Patients undergo psychoeducation focusing on cognitive impairment understanding, behavioural strategies to enhance cognitive functioning, and acceptance strategies through mindfulness and metaphors. 3. rd level. Online Cognitive Training: Individual 30-minute online cognitive training sessions are conducted twice a week for 12 weeks, targeting specific cognitive skills. Sessions are facilitated through the CogniFit program, integrated with the ICOnnecta't App.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Women within 6 weeks after a Breast Cancer diagnosis * Having online access and a user-level knowledge of the internet * Understanding of Spanish language Exclusion Criteria: * Any additional medical condition that may affect neuropsychological performance * Presence of a psychiatric condition including substance use disorders in the last 3 months (excluding tobacco addiction) * Significant autolytic ideation
References
Publications (21)
- BACKGROUNDO'Farrell E, Smith A, Collins B. Objective-subjective disparity in cancer-related cognitive impairment: does the use of change measures help reconcile the difference? Psychooncology. 2017 Oct;26(10):1667-1674. doi: 10.1002/pon.4190. Epub 2016 Jul 14. PMID 27278814
- BACKGROUNDEide S, Feng ZP. Doxorubicin chemotherapy-induced "chemo-brain": Meta-analysis. Eur J Pharmacol. 2020 Aug 15;881:173078. doi: 10.1016/j.ejphar.2020.173078. Epub 2020 Jun 5. PMID 32505665
- BACKGROUNDJim HS, Phillips KM, Chait S, Faul LA, Popa MA, Lee YH, Hussin MG, Jacobsen PB, Small BJ. Meta-analysis of cognitive functioning in breast cancer survivors previously treated with standard-dose chemotherapy. J Clin Oncol. 2012 Oct 10;30(29):3578-87. doi: 10.1200/JCO.2011.39.5640. Epub 2012 Aug 27. PMID 22927526
- BACKGROUNDStewart A, Bielajew C, Collins B, Parkinson M, Tomiak E. A meta-analysis of the neuropsychological effects of adjuvant chemotherapy treatment in women treated for breast cancer. Clin Neuropsychol. 2006 Feb;20(1):76-89. doi: 10.1080/138540491005875. PMID 16410227
- BACKGROUNDLange M, Joly F, Vardy J, Ahles T, Dubois M, Tron L, Winocur G, De Ruiter MB, Castel H. Cancer-related cognitive impairment: an update on state of the art, detection, and management strategies in cancer survivors. Ann Oncol. 2019 Dec 1;30(12):1925-1940. doi: 10.1093/annonc/mdz410. PMID 31617564
- BACKGROUNDBoscher C, Joly F, Clarisse B, Humbert X, Grellard JM, Binarelli G, Tron L, Licaj I, Lange M. Perceived Cognitive Impairment in Breast Cancer Survivors and Its Relationships with Psychological Factors. Cancers (Basel). 2020 Oct 16;12(10):3000. doi: 10.3390/cancers12103000. PMID 33081111
- BACKGROUNDMackenzie L, Marshall K. Effective non-pharmacological interventions for cancer related cognitive impairment in adults (excluding central nervous system or head and neck cancer): systematic review and meta-analysis. Eur J Phys Rehabil Med. 2022 Apr;58(2):258-270. doi: 10.23736/S1973-9087.21.06898-2. Epub 2021 Sep 9.