Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Substance Related Disorders

Breast Neoplasms

Cognitive Dysfunction

Chemotherapy-Related Cognitive Impairment

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Quality of Life

Online games designed to target specific cognitive skills such as attention, perception, or inhibition). Activities' difficulty will be automatically adjusted accordingly to each participant's performance, always demanding a maximum cognitive effort.

Online painting and artistic games designed not to target the specific cognitive skills at test. Activities' duration will match those of the experimental group, and its difficulty will be constant through the intervention.

Online gamified activities designed to stimulate cognitive functions (specifically executive function) will be carried out through a mobile application or web browser. Performance feedback will be shown after each activity.

Personalized cognitive stimulation

Non-therapeutic online games based on artistic tasks designed to not train the specific cognitive abilities at test. The time of each session will match that of the experimental group. Performance feedback will be shown after each game.

Sham cognitive stimulation

Jon A Duñabeitia

Jose L Tapia

Maria T Taberner

Athanasious Pouptsis

David Collado

Martín Núñez

The present study aims to establish a non-pharmacological alternative in alleviating cognitive deterioration derived from undergoing chemotherapy treatment. Thus, the effectiveness of a personalized and computerized cognitive stimulation program in breast cancer survivors is assessed.

A phase I/II/III clinical trial is proposed in which the first two phases will serve to evaluate the safety of the intervention and the maximum tolerated time of computerized cognitive training per session in the absence of adverse effects. The third phase will consist of a double-blind randomized controlled trial where the effectiveness of the personalized and self-administered computerized cognitive stimulation program will be evaluated.

Phase I. Based on a dose-escalation 3+3 design, experienced fatigue or adverse effects will be measured after succeeding 15 minutes cognitive stimulation training blocks. The training dose will be set to a block before extreme fatigue or notable adverse effect has been reported by two or more participants. A trained psychologist will supervise the process.

Phase II. To evaluate the effectiveness of the intervention, 20 participants will undertake an interspersed training day and evaluation day through 15 consecutive days. In this way, a total of 8 evaluation sessions (day 1, 3, 5, 7, 9, 11, 13, and 15) and 7 cognitive stimulation sessions (day 2, 4, 6, 8, 10, 12, and 14) will be carried out. A trained psychologist will supervise every step of the process.

Phase III. An 8-week personalized and computerized cognitive stimulation program will be established, where the training time per session will be as determined on phase I. 120 participants will be randomized 1:1 ratio to an intervention or active control group. All participants will undertake a pre and post-test, with a total of 40 training sessions (Monday to Friday) during 8 weeks. Although this phase is set to be an online home-based stage, the responsible psychologist will be monitoring participants' performance and will periodically contact participants via telephone.

A home-based intervention will be set through the CogniFit® online platform. Participants will access remotely from home using a personal computer or smart device. The cognitive stimulation program will be held for 5 consecutive days (Monday to Friday) for 8 weeks, completing a total of 40 training sessions. Researchers will supervise the participant's performance daily and will periodically contact participants via telephone.

The intervention platform will randomly assign participants in a 1:1 ratio to one out of two groups (control/experimental), so both participants and researchers are blinded.

Activities presented to the experimental group will target specific cognitive domains (mainly executive functions) and will be automatically adjusted in difficulty and requirement according to each participant's performance. Thus, maximum cognitive effort is always required.

Activities presented to the active control group will target orthogonal unrelated cognitive domains (i.e. artistic cognitive processes) and will be of constant difficulty.

Since the study population is breast cancer survivors, and considering its epidemiology, investigators will restrict participants to females.

Cognitive Stimulation and Chemobrain. An Innovative Intervention for Cancer Survivors

Cognitive Stimulation Intervention Program for Cancer Survivors and Its Benefit on Cognitive Performance and Quality of Life

The data protection policy of the public health system of the Spanish government does not allow researchers to share individual participant data.

The mini-MAC is a validated 29-item self-rated questionnaire that examines five cancer-specific coping strategies: fighting spirit, helplessness, anxious preoccupation, cognitive avoidance, and fatalism. Each item is scored using a 4-point Likert scale. Higher scores on each subscale mean greater use of that strategy.

The CAB-CF is an online neuropsychological assessment battery that evaluates a total of 23 cognitive skills, grouped into 5 cognitive domains (attention, memory, coordination, perception, and reasoning). Each cognitive skill is scored from 0 to 800. The cognitive domain score is calculated by averaging the scores of the cognitive skills that comprise it. Higher scores mean better cognitive performance.

The FACT-COG is a 37 item self-report questionnaire that assesses patients' perception of their cognitive abilities, functionality, and quality of life. Each item is scored using a 5-point Likert scale. Higher scores indicate less perceived cognitive impairment.

The STAI is a validated self-report that assesses anxiety that measures both trait and state anxiety. Each item is scored using a 4-point Likert scale. Possible scores range from 0 (no anxiety) to 60 (severe anxiety), for each category.

The BDI-II is a validated 21-item self-report inventory designed to measure the frequency and severity of depressive symptoms. Scores range from 0 (no depressive symptoms) to 63 (severe depression).

The BFI is a 9-items instrument designed to assess the severity and impact of cancer-related fatigue. For the three items that assess fatigue severity, scores range from 0 (no fatigue) to 10 (the worst fatigue you can imagine). For the six items that assess how fatigue interferes with daily life, scores range from 0 (does not interfere) to 10 (interferes completely).

The WHOQOL-BREF is a 26-question questionnaire designed to measure the quality of life. It has two questions concerning the general satisfaction with health, and the remaining 24 questions are grouped in four areas: physical health, psychological health, social relations, and environment. Scores for each domain range from 0 (poor perceived quality of life) to 100 (greater perceived quality of life)

The C-SSRS is a questionnaire designed to assess the existence of thoughts, desires or behaviors related to suicidal ideation, assessing a total of ten categories (wish to be dead; non-specific active suicidal thoughts; active suicidal ideation with any methods without intent to act; active suicidal ideation with some intent to act, without a specific plan; active suicidal Ideation with a specific plan and intent; preparatory acts or behavior; aborted attempt; interrupted attempt; actual attempt; completed suicide. The questionnaire can be administered as a self-report, with additional open-ended follow-up questions to provide more information. Scoring refers to the presence or absence of each of the 10 categories, provided by the dichotomous responses (Yes/No).

Hospital de la Ribera

Universidad Antonio de Nebrija

Director

Breast Diseases

Skin Diseases

This arm will receive a 5-month (20 weeks) supervised exercise program based on aerobic and resistance/strength training together with a weekly calorie or step challenge.

This arm will receive a 5-month (20 weeks) supervised and simultaneous dual-task program based on aerobic, resistance, and cognitive stimulation training together with a weekly calorie or step challenge

This arm will receive a 5-month health and wellness program.

Participants will complete a 5-month exercise program structured in 4 blocks of 5 weeks. Three supervised and combined aerobic/strength exercise sessions each week will be performed together with an aerobic weekly challenge. Aerobic exercise will be performed for 20-30 minutes using a treadmill, bicycle, or circuit training at light to moderate intensities (40-75% of heart rate reserve) during the first two blocks; gradually achieving high intensity (\>75% of HHR) in the last two blocks. Heart rate and the subjective perception of the exertion scale (6-20 Borg scale) will be monitored. Strength exercises will be started at light to moderate intensities (2 sets of 15-20 repetitions at 40-50% of repetition maximum), performed muscle actions at high intensities in the last two blocks (2 sets of 8-15 repetitions at 50-75% RM); using elastic bands, free weights, and weights gym exercises.

Exercise

Participants will complete the same four-block exercise program in terms of type, frequency, intensity, and volume of physical/motor training. Simultaneous with the progression of physical/motor training, the complexity of cognitive stimulation will be increased according to the performance of the participants. General dual-task training will be performed, which describes the use of a physical/motor intervention with different cognitive stimulations (memory, language, intelligence, attention, processing speed, calculation, inhibitory control) that are not specific to the methods to be used for their assessment.

Motor-cognitive Training

Participants randomly assigned to the health and wellness group will be advised and re-educated to support and improve health aspects. Participants in this group will aim to achieve the physical activity recommendations, and in addition, they will receive bi-weekly emails and phone call coaching with tools to empower patients with knowledge about physical exercise, nutrition, and brain health guidelines. Following completion of the 5-month exercise program, this group will receive an exercise program for 12 weeks.

Health and Wellness

Jesus Orellana

Luis Carrasco Páez, PhD

Jorge Tihriet

Alfonso J García González

Lourdes Valero

Matilde Mora Fernández, PhD

Jesús Orellana Jaén

The goal of this interventional study is to assess the effects of either physical exercise program or combined with cognitive training (dual motor and cognitive training program) on breast cancer survivors. The main questions it aims to answer are:

* Analyze the effectiveness of a supervised dual-task training program or a physical exercise program on the executive functions of the participants.
* Evaluate the impact of both interventions on physical function, emotional aspects, and important biomarkers related to muscle-brain crosstalk.

Participants will perform a 20-week supervised and controlled program, three times a week, along with weekly calorie and step challenges.

Researchers will compare the dual-task training group, with the physical exercise group, and with a control group, which will perform the guideline recommendations of physical activity (non-supervised) to see how these intervention approaches can impact cognitive functions, physical functions, emotional aspects, and biomarkers related to muscle-brain crosstalk.

Assessments will take place at three-time points: at baseline, after the intervention (20 weeks post-baseline) and after a 12-week follow-up period (32 weeks post-baseline).

This study has been designed as a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks).

Regarding the control of experimental bias, simple blinding will be used. Thus, participants will be blinded to the research problem. They will be informed that three interventions will be applied (without comment on specific details of each one) randomly allocated, to compare the impact on cognitive functions, circulating levels of certain biomarkers, and different symptoms associated with breast cancer. Therefore, study participants will not be able to know to which experimental or control group they belong.

Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT).

Motor-cognitive Training Effects on Cancer-related Cognitive Impairment and Muscle-brain Crosstalk Biomarkers in Breast Cancer Survivors: the BRAINonFIT Study

Trail Making Test A and B (minimum and maximum values, defined by the time in seconds, depend on the age- and education-normalised groups; higher scores mean worse results)

Stroop Color and Word test (minimum and maximum values, defined by the time in seconds, depend on the age- and education-normalised groups; higher scores mean worse results)

Reynolds Intellectual Assessment Scale (Global index values range from ≤ 69 to ≥ 130, mean value of 100; higher scores mean better results)

Wechsler Memory Scale subtest "word pairs" (The subtest score range from 40 to 60, mean value of 100; higher scores mean better results)

Functional Assessment of Cancer Therapy: Cognition (FACT-Cog) (Total score ranges from 0 to 148; higher scores mean better results)

Spirometry (FEV/FVC ratio, represented in percentages)

Accelerometer (Volume in minutes per week)

Accelerometer (Intensity in metabolic equivalents)

Body Mass Index (weight and height will be combined to report BMI in kg/m\^2)

Concentration of these proteins in plasma by ELISA kit (Concentration of these proteins will be expressed in pg/mL or ng/mL)

Functional Assessment of Chronic Illness Therapy: Fatigue (FACIT-F) (Total score range from 0 to 52; higher scores mean better results)

Visual Analogue Scale (Total score ranges from 0 to 10; higher scores mean worse results)

Back Depression Inventory (Total score ranges from 0 to 63; higher scores mean worse results)

State-Trait Anxiety Inventory (The score ranges from 20 to 80; higher scores mean worse results)

University of Seville

Principal Investigator

3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days

Cognitive stimulation

Numerous studies have shown the impact of anti-cancer treatments on cognition and more particularly that of chemotherapy. Elderly patients also seem to be at higher risk of developing cognitive impairment. These disorders can have a particularly negative impact in this population, in particular by having repercussions on the observance of oral treatments or even on autonomy. However, investigators still have little data concerning the management of cognitive disorders induced by oncology treatments, particularly in the elderly patient. It is therefore necessary to offer care adapted to this population which will allow the reduction of the sequelae induced by cancer treatments and the improvement of the quality of life of elderly patients.Although there are no preventive measures yet, recent studies of young women being treated for breast cancer with a cognitive complaint have shown a beneficial effect of cognitive stimulation on these cognitive disorders. Stimulation programs of this type have been developed in electronic format. However, to date, they have not been the subject of specific studies with elderly patients in whom the use of computer interface can be an obstacle.Sponsor propose to set up a study aimed at evaluating the feasibility of using cognitive stimulation software on tablets with elderly patients.The HAPPYNeuron® software, developed by a French team of neurologists, speech-language pathologists and psychiatrists, offers exercises to be performed online to stimulate the cognitive functions most impaired by oncological treatments (memory, attention, executive functions and speed of treatment).For this feasibility study, the sponsor plan to include 50 patients aged 70 and over to have them test the acceptance of cognitive stimulation by this software with a tablet interface.

Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study

Satisfaction questionnary (Patient satisfaction questionnary; minimum 1 to maximum 5; 8 questions)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cognitive Stimulation and Chemobrain. An Innovative Intervention for Cancer Survivors	NCT05409248	Breast Cancer Cognitive Decli...	Personalized co... Sham cognitive ...	18 Years -	Universidad Antonio de Nebrija
Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT).	NCT06073717	Breast Cancer S... Cognitive Impai... Executive Dysfu...	Exercise Motor-cognitive... Health and Well...	25 Years - 65 Years	University of Seville
Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study	NCT04261153	Breast Cancer	Cognitive stimu...	70 Years -	Centre Francois Baclesse

Spots Global Cancer Trial Database for cognitive stimulation