Active — Not RecruitingNot Applicable

Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)

Spain82 participantsStarted 2023-09-27

Plain-language summary

The goal of this clinical trial is to test a home-delivered intervention that combines Non-Invasive Brain Stimulation techniques (transcranial direct and alternating current stimulation -tDCS and tACS-) and Online Cognitive Training (OCT) to treat depressive symptomatology and cognitive decline associated with breast cancer. The main questions aims to be answered are: * To analyze the efficacy and feasibility of the intervention to treat depressive symptomatology. * To analyze the efficacy and feasibility of the intervention to treat cognitive decline. * To evaluate the medium and long-term effects (1, 3 and 6 months) of intervention. An OCT program and a portable wireless tDCS/tACS system will be used to perform the intervention at home. Patients will be divided into four treatment groups, depending on whether they will receive the OCT applied independently or combined with tDCS/tACS active or sham. In addition, saliva samples will be collected to identify bomarkers predictive of treatment efficacy.

Who can participate

Age range

30 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of breast cancer in early stages (life expectancy greater than 12 months). * Patients who are receiving or have finished (maximum 6 months prior to participation in the participating in the study) some type of oncological treatment (Chemotherapy, Radiotherapy, Immunotherapy, Hormonal Therapy). * Patients whose mother tongue is Galician or Spanish. * Ability to give informed consent. * Present depressive symptomatology: score of 4 or higher in the BDI-FS. * Ability to use WhastApp * Have access to some technology (desktop computer, laptop or tablet) and the Internet (Firefox or Chrome browsers). Exclusion Criteria: * Pregnant or breastfeeding women. * Patients with metastasis. * Patients with a mental health disorder (major depressive disorder, bipolar,anxious, psychotic...) diagnosed by a psychiatrist prior to the oncological process. * Patients with a history of cognitive impairment or dementia prior to the oncologic process. oncological process. * Patients with a history of neurosurgery, cortical lesions or neurological alterations prior to the oncological process. * Patients with history or current consumption of non-prescribed drugs. * Patients with the following medication regimen: mood stabilizers, antipsychotics, anticonvulsants, l-dopa, rivastigmine, dextromethorphan, flunarizine, sulpiride, use of benzodiazepines (excluding long half-life benzodiazepines (Bromazepam, Diazepam) on a continuous/habitual basis,Alprazolam \>1mg per da…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Beck Depression Inventory- Fast Screen (BDI-FS)

Timeframe: pre-, post- intervention (15 days) and follow-up (1,3,6 months)

Trial details

NCT IDNCT06053775

SponsorUniversity of Santiago de Compostela

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09

View on ClinicalTrials.gov More Depressive Symptoms trials