Breast CancerICOgnitionNCT06103318
eHealth Interventions for Breast Cancer Cognitive Impairment
A study testing ICOgnition in people with Breast Cancer and Cognitive Dysfunction, run by Institut Català d'Oncologia.
Trial summary
This study investigates the effectiveness of integrating a cognitive rehabilitation module into a digital psychosocial intervention for recently diagnosed breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Cognitive Dysfunction
- What is being tested?
- ICOgnition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2024to 7 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women within 6 weeks after a Breast Cancer diagnosis
- Having online access and a user-level knowledge of the internet
- Understanding of Spanish language
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cognitive Rehabilitation and Psychosocial Intervention Through a Stepped Digital Ecosystem in Breast Cancer: A Randomized Clinical Trial.
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.
Read the detailed description
BACKGROUND
Breast cancer (BC) diagnoses have increased, and while survival rates have improved, the focus on the quality of life (QoL) for survivors, including cognitive function, has intensified. Cancer-related cognitive impairment (CRCI) is recognized, encompassing objective deficits and subjective experiences. Various factors, such as chemotherapy agents, stress, and psychological factors, influence CRCI. Non-pharmacological treatments, including psychoeducational interventions and cognitive training, have shown promise. However, there are barriers in oncological settings, including a lack of awareness and standardized protocols. Current developed technologies like eHealth offer solutions, yet studies addressing cognitive care in eHealth psychosocial interventions are limited. This study aims to assess the ICOgnition digital intervention's effectiveness in improving BC patients' subjective and objective cognitive symptoms. It also explores factors influencing cognitive function, the effectiveness of online cognitive testing, and the gap between objective and subjective deficits. The study will also evaluate the feasibility and cost-effectiveness of ICOnnecta't + ICOgnition interventions to provide insights into their scalability and sustainability. The hypothesis suggests that the ICOnnecta't-enhanced intervention (ICOgnition) will outperform ICOnnecta't alone in improving both subjective and objective cognitive functioning in BC patients.
METHODS/DESIGN
The trial is conducted at the Catalan Institute of Oncology (ICO) in Hospitalet de Llobregat. Patients meeting inclusion criteria are referred by the Breast Functional Unit to the ICOnnecta't Program team. Eligible candidates receive detailed study information via a call and, if willing to participate, schedule an in-person appointment at the ICOnnecta't Space. Researchers explain the study, obtain informed consent, and utilize the secure web platform REDCap for questionnaires. Assessments occur at baseline (T1), 3 months (T2), 6 months (T3), and 12 months (T4). Recruitment starts in December 2023 and spans a year.
Breast cancer patients will be randomly assigned to one of the two treatment groups using REDCap, employing a simple randomization method (1:1).
- Study Sample
The study will include 176 female breast cancer patients in the acute survival phase from ICO Hospitalet.
- Statistical Analysis:
Primary Outcome Analysis
The study will employ independent Linear Mixed Models with patients clustered to analyze cognitive outcomes between the two intervention groups: digital stepped psychosocial care vs. digital stepped psychosocial care + cognitive module. Subjective Cognition (FACT-Cog) and Objective Cognition (Neurocognitive Index) will be separately assessed, adjusting for age and education. Descriptive statistics, effect sizes, and 95% confidence intervals will be reported.
Secondary Outcome Analysis
Linear Mixed Models will be used to analyze secondary outcomes (e.g., depression, anxiety, distress, quality of life) following the same procedure. Mediation analysis will explore emotional distress and posttraumatic stress as mediators between interventions and cognitive responses.
Other Pre-Specified Outcome Analyses
- Discrepancy between Objective and Subjective Measures: Standardized values will be compared using ICC, Bland-Altman Plot, and linear regression to identify variables explaining discrepancies.
- Clusters of Cognitive Impairment: Cluster analysis will identify participant groups with similar cognitive profiles and explore differences in demographics, clinical variables, and treatment response.
- Cognitive Assessment Optimization: The equivalence of online vs. paper and pencil tests in detecting cognitive impairment will be tested, and the most sensitive test for CRCI detection will be explored.
- Cost-Utility Analysis: This analysis expresses the cost-effectiveness of interventions in terms of cost per Quality-Adjusted Life Year (QALY) gained, a common measure used in healthcare decision-making.
- Statistical Power:
Utilizing GLIPMPSE, the study has a power of 0.802 with a significance level of 0.05. With 176 subjects (88 in each group), the study can detect a significant difference of 5.9 units, assuming a common standard deviation of 15, based on previous research findings (Bell et al., 2018).
- Discussion
The ICOgnition intervention offers a promising and comprehensive approach to address cognitive difficulties in newly diagnosed breast cancer patients. By integrating digital psychosocial support, personalized cognitive training, and psychoeducational resources, this intervention aims to enhance cognitive function and improve the overall quality of life for patients. Notably, its potential impact could extend to individuals facing cognitive challenges in various medical conditions beyond breast cancer. However, challenges related to implementation, resource allocation, patient adherence, and economic evaluation need careful consideration to ensure the intervention's effectiveness in real-world settings. If successfully implemented, ICOgnition could serve as a valuable model for addressing cognitive impairments, fostering a better understanding of cognitive challenges in medical settings, and enhancing patients' overall well-being.
- Conditions
- Breast Cancer, Cognitive Dysfunction
- Being tested
- ICOgnition
- Keywords
- eHealth, Breast Cancer, Cancer Related Cognitive Impairment (CRCI), Chemobrain, Psychoeducation, Cognitive Training, Emotional distress, Randomised Control Trial, Psycho-oncology, Digital Health, Quality of Life
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction, Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICOgnitionBehavioural
Also called Psychoeducational and Cognitive Training
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.
| Study group | Role | What they receive |
|---|---|---|
| ICOnnectat | Active comparator | 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. Receives: Behavioral: ICOgnition |
| ICOgnition | Experimental | 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. Receives: Behavioral: ICOgnition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Subjective cognition
The Functional Assessment of Cancer Therapy-Cognitive Function, FACT-Cog, Perceived Cognitive Impairment sub-scale (PCI), developed specifically to assess cognitive difficulties in cancer patients (https://www.facit.org/measures/FACT-Cog) is used. Lower scores (0-72) indicate a poor perceived performance.
Measured: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months
Change in Objective Cognition (Digital assessment)
The objective cognitive assessment will be provided by the licensed computer program CogniFit Inc © 2023. CogniFit offers a specific cognitive assessment called "Chemfog," which measures 6 cognitive domains: planning, processing speed, short-term memory, focus attention, coordination and spatial perception. Lower scores (0-800) indicate poor objective performance in those domains.
Measured: Assessment will be conducted at baseline and at 12 months
Change in Objective Cognition (Paper and pencil assessment)
Verbal Learning, Immediate Verbal Memory and Delayed Verbal Memory will be measured through RAVLT - Rey Auditory Verbal Learning Test. The executive functions domains that will be measured are cognitive flexibility through Trail Making Test B (TMT-B) [50], verbal fluency through its Spanish version and working memory through Digit Span backward of the Wechsler Adult Intelligence Scale IV (WAIS-IV). Attention will be measured via TMT-A and Digit Span forward (WAIS-IV). Finally, Digit Symbol Substitution Test (DSST; WAIS-IV) will be used to measure processing speed.
Measured: Assessment will be conducted at baseline and at 12 months
Secondary outcomes (8)
Change in emotional distress
Hospital Anxiety and Depression Scale (HADS) will be used to assess emotional distress through 7 anxiety items (HADS-Anxiety) and 7 depression items (HADS-Depression). The range of scores is 0-21 for each subscale, and 0-42 for the overall questionnaire, where higher scores indicate worse clinical symptoms
Measured: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months
Change in Medication adherence
Medication adherence will be assessed through the Spanish version of Adherence to Refill and Medication Scale (ARMS-e), which is a valid and reliable scale for patients with chronic disease. This instrument consists of 12 questions: 8 are focused on the patient's consistency in taking medication appropriately and 4 on their proper collection. Lower overall scores correspond to better adherence.
Measured: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months
Change in Quality of Life
The European Quality of Life Scale (EQ-5D- 3L) provides a measure of Health-Related QoL (HRQoL) and is helpful for the evaluation of the cost-utility of health interventions. Lower scores represent worst health status.
Measured: Assessment will be conducted at baseline and at 12 months
Post-traumatic Stress
The Post-traumatic Stress Disorder Checklist (PCL-5) is widely used in clinical and research settings to screen for post-traumatic symptoms. Higher scores indicate a higher severity of post-traumatic symptoms
Measured: Assessment will be conducted at baseline and at 12 months
Changes in Work role functioning
Work Role Functioning Questionnaire (WRFQ): a self-report assessment tool, validated in cancer patients and in Spanish population, that is used to evaluate an individual's work-related functioning and productivity. It is specifically designed to measure how mental health symptoms and conditions impact an individual's ability to perform in a work environment. Higher scores indicate better work-related functioning.
Measured: Assessment will be conducted at baseline and at 12 months
Changes in Health Literacy
Health literacy will be measured with a visual analogue scale with the following question (translated from Spanish): "Please indicate your level of satisfaction with the information provided to you by the Catalan Institute of Oncology (ICO) regarding your illness and treatments, where 0 is very dissatisfied with the information received, and 10 is very satisfied with the information received ".
Measured: Assessment will be conducted at baseline and at 12 months
Intervention Satisfaction
Intervention Satisfaction will be measured with a visual analogue scale with the following question (translated from Spanish): "Rate from 0 to 10 to what extent you are satisfied with the ICOnnecta't/ICognition Intervention, where 0 is completely dissatisfied and 10 is completely satisfied".
Measured: Assessment will be conducted at 3 months
ICOnnecta't / ICOgnition App Usability
App Usability will be measured with a visual analogue scale with the following question (translated from Spanish): "Rate from 0 to 10 to what extent you found the application easy to use, where 0 is very difficult to use and 10 is very easy to use"
Measured: Assessment will be conducted at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start14 Mar 2024 (estimated)
- Primary completion7 Apr 2025 (estimated)
- Study completion7 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study proposes a superiority RCT with two parallel groups (online psychosocial care vs. online integrated and stepped cognitive intervention) with 1:1 allocation. The study design will contain 2 (treatment conditions) × 3 (follow-up assessments) factors.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Carlos III Health Institute
- Responsible party
- Principal investigator, Cristian Ochoa Arnedo, Institut Català d'Oncologia
- Investigators
- Cristian Ochoa Arnedo, PhD, Principal investigator, Institut Català d'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103318
- Sponsor's protocol ID
- PI22/01255
- Other IDs
- PR270/22
- Acronym
- ICOgnition
- Status last verified
- Mar 2024
- First submitted
- 23 Oct 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'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.
PubMed 27278814Eide 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.
PubMed 32505665Jim 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.
PubMed 22927526Stewart 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.
PubMed 16410227Lange 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.
PubMed 31617564Boscher 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.
PubMed 33081111Mackenzie 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.
PubMed 34498828Treanor CJ, McMenamin UC, O'Neill RF, Cardwell CR, Clarke MJ, Cantwell M, Donnelly M. Non-pharmacological interventions for cognitive impairment due to systemic cancer treatment. Cochrane Database Syst Rev. 2016 Aug 16;2016(8):CD011325. doi: 10.1002/14651858.CD011325.pub2.
PubMed 27529826Kim Y, Kang SJ. Computerized programs for cancer survivors with cognitive problems: a systematic review. J Cancer Surviv. 2019 Dec;13(6):911-920. doi: 10.1007/s11764-019-00807-4. Epub 2019 Oct 5.
PubMed 31587187Binarelli G, Joly F, Tron L, Lefevre Arbogast S, Lange M. Management of Cancer-Related Cognitive Impairment: A Systematic Review of Computerized Cognitive Stimulation and Computerized Physical Activity. Cancers (Basel). 2021 Oct 14;13(20):5161. doi: 10.3390/cancers13205161.
PubMed 34680310Binarelli G, Lange M, Dos Santos M, Grellard JM, Lelaidier A, Tron L, Lefevre Arbogast S, Clarisse B, Joly F. Multimodal Web-Based Intervention for Cancer-Related Cognitive Impairment in Breast Cancer Patients: Cog-Stim Feasibility Study Protocol. Cancers (Basel). 2021 Sep 28;13(19):4868. doi: 10.3390/cancers13194868.
PubMed 34638354Penedo FJ, Oswald LB, Kronenfeld JP, Garcia SF, Cella D, Yanez B. The increasing value of eHealth in the delivery of patient-centred cancer care. Lancet Oncol. 2020 May;21(5):e240-e251. doi: 10.1016/S1470-2045(20)30021-8.
PubMed 32359500Medina JC, Flix-Valle A, Rodriguez-Ortega A, Hernandez-Ribas R, Lleras de Frutos M, Ochoa-Arnedo C. ICOnnecta't: Development and Initial Results of a Stepped Psychosocial eHealth Ecosystem to Facilitate Risk Assessment and Prevention of Early Emotional Distress in Breast Cancer Survivors' Journey. Cancers (Basel). 2022 Feb 15;14(4):974. doi: 10.3390/cancers14040974.
PubMed 35205722Kaiser J, Dietrich J, Amiri M, Ruschel I, Akbaba H, Hantke N, Fliessbach K, Senf B, Solbach C, Bledowski C. Cognitive Performance and Psychological Distress in Breast Cancer Patients at Disease Onset. Front Psychol. 2019 Nov 15;10:2584. doi: 10.3389/fpsyg.2019.02584. eCollection 2019.
PubMed 31803117Ciria-Suarez L, Costas L, Flix-Valle A, Serra-Blasco M, Medina JC, Ochoa-Arnedo C. A Digital Cancer Ecosystem to Deliver Health and Psychosocial Education as Preventive Intervention. Cancers (Basel). 2022 Jul 30;14(15):3724. doi: 10.3390/cancers14153724.
PubMed 35954388
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation and Psychosocial Intervention Through a Stepped Digital Ecosystem in Breast Cancer: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06103318
- Acronym / sponsor ID
- ICOgnition / PI22/01255
- Conditions
- Breast Cancer, Cognitive Dysfunction
- Keywords
- eHealth, Breast Cancer, Cancer Related Cognitive Impairment (CRCI), Chemobrain, Psychoeducation, Cognitive Training, Emotional distress, Randomised Control Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge, Carlos III Health Institute
- Study start
- 14 Mar 2024 (estimated)
- Primary completion
- 7 Apr 2025 (estimated)
- Study completion
- 7 Sep 2025 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND
Breast cancer (BC) diagnoses have increased, and while survival rates have improved, the focus on the quality of life (QoL) for survivors, including cognitive function, has intensified. Cancer-related cognitive impairment (CRCI) is recognized, encompassing objective deficits and subjective experiences. Various factors, such as chemotherapy agents, stress, and psychological factors, influence CRCI. Non-pharmacological treatments, including psychoeducational interventions and cognitive training, have shown promise. However, there are barriers in oncological settings, including a lack of awareness and standardized protocols. Current developed technologies like eHealth offer solutions, yet studies addressing cognitive care in eHealth psychosocial interventions are limited. This study aims to assess the ICOgnition digital intervention's effectiveness in improving BC patients' subjective and objective cognitive symptoms. It also explores factors influencing cognitive function, the effectiveness of online cognitive testing, and the gap between objective and subjective deficits. The study will also evaluate the feasibility and cost-effectiveness of ICOnnecta't + ICOgnition interventions to provide insights into their scalability and sustainability. The hypothesis suggests that the ICOnnecta't-enhanced intervention (ICOgnition) will outperform ICOnnecta't alone in improving both subjective and objective cognitive functioning in BC patients.
METHODS/DESIGN
The trial is conducted at the Catalan Institute of Oncology (ICO) in Hospitalet de Llobregat. Patients meeting inclusion criteria are referred by the Breast Functional Unit to the ICOnnecta't Program team. Eligible candidates receive detailed study information via a call and, if willing to participate, schedule an in-person appointment at the ICOnnecta't Space. Researchers explain the study, obtain informed consent, and utilize the secure web platform REDCap for questionnaires. Assessments occur at baseline (T1), 3 months (T2), 6 months (T3), and 12 months (T4). Recruitment starts in December 2023 and spans a year.
Breast cancer patients will be randomly assigned to one of the two treatment groups using REDCap, employing a simple randomization method (1:1).
- Study Sample
The study will include 176 female breast cancer patients in the acute survival phase from ICO Hospitalet.
- Statistical Analysis:
Primary Outcome Analysis
The study will employ independent Linear Mixed Models with patients clustered to analyze cognitive outcomes between the two intervention groups: digital stepped psychosocial care vs. digital stepped psychosocial care + cognitive module. Subjective Cognition (FACT-Cog) and Objective Cognition (Neurocognitive Index) will be separately assessed, adjusting for age and education. Descriptive statistics, effect sizes, and 95% confidence intervals will be reported.
Secondary Outcome Analysis
Linear Mixed Models will be used to analyze secondary outcomes (e.g., depression, anxiety, distress, quality of life) following the same procedure. Mediation analysis will explore emotional distress and posttraumatic stress as mediators between interventions and cognitive responses.
Other Pre-Specified Outcome Analyses
- Discrepancy between Objective and Subjective Measures: Standardized values will be compared using ICC, Bland-Altman Plot, and linear regression to identify variables explaining discrepancies.
- Clusters of Cognitive Impairment: Cluster analysis will identify participant groups with similar cognitive profiles and explore differences in demographics, clinical variables, and treatment response.
- Cognitive Assessment Optimization: The equivalence of online vs. paper and pencil tests in detecting cognitive impairment will be tested, and the most sensitive test for CRCI detection will be explored.
- Cost-Utility Analysis: This analysis expresses the cost-effectiveness of interventions in terms of cost per Quality-Adjusted Life Year (QALY) gained, a common measure used in healthcare decision-making.
- Statistical Power:
Utilizing GLIPMPSE, the study has a power of 0.802 with a significance level of 0.05. With 176 subjects (88 in each group), the study can detect a significant difference of 5.9 units, assuming a common standard deviation of 15, based on previous research findings (Bell et al., 2018).
- Discussion
The ICOgnition intervention offers a promising and comprehensive approach to address cognitive difficulties in newly diagnosed breast cancer patients. By integrating digital psychosocial support, personalized cognitive training, and psychoeducational resources, this intervention aims to enhance cognitive function and improve the overall quality of life for patients. Notably, its potential impact could extend to individuals facing cognitive challenges in various medical conditions beyond breast cancer. However, challenges related to implementation, resource allocation, patient adherence, and economic evaluation need careful consideration to ensure the intervention's effectiveness in real-world settings. If successfully implemented, ICOgnition could serve as a valuable model for addressing cognitive impairments, fostering a better understanding of cognitive challenges in medical settings, and enhancing patients' overall well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study proposes a superiority RCT with two parallel groups (online psychosocial care vs. online integrated and stepped cognitive intervention) with 1:1 allocation. The study design will contain 2 (treatment conditions) × 3 (follow-up assessments) factors.
| Arm | Type | Receives |
|---|---|---|
| ICOnnectat | Active comparator | Behavioral: ICOgnitionICOnnecta'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. |
| ICOgnition | Experimental | Behavioral: ICOgnitionICOgnition 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women within 6 weeks after a Breast Cancer diagnosis
- Having online access and a user-level knowledge of the internet
- Understanding of Spanish language
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICOgnitionAlso: Psychoeducational and Cognitive TrainingThe 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. | Behavioural | ICOgnition, ICOnnectat |
Primary outcome
Change in Subjective cognition
Time frame: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months
The Functional Assessment of Cancer Therapy-Cognitive Function, FACT-Cog, Perceived Cognitive Impairment sub-scale (PCI), developed specifically to assess cognitive difficulties in cancer patients (https://www.facit.org/measures/FACT-Cog) is used. Lower scores (0-72) indicate a poor perceived performance.
Change in Objective Cognition (Digital assessment)
Time frame: Assessment will be conducted at baseline and at 12 months
The objective cognitive assessment will be provided by the licensed computer program CogniFit Inc © 2023. CogniFit offers a specific cognitive assessment called "Chemfog," which measures 6 cognitive domains: planning, processing speed, short-term memory, focus attention, coordination and spatial perception. Lower scores (0-800) indicate poor objective performance in those domains.
Change in Objective Cognition (Paper and pencil assessment)
Time frame: Assessment will be conducted at baseline and at 12 months
Verbal Learning, Immediate Verbal Memory and Delayed Verbal Memory will be measured through RAVLT - Rey Auditory Verbal Learning Test. The executive functions domains that will be measured are cognitive flexibility through Trail Making Test B (TMT-B) [50], verbal fluency through its Spanish version and working memory through Digit Span backward of the Wechsler Adult Intelligence Scale IV (WAIS-IV). Attention will be measured via TMT-A and Digit Span forward (WAIS-IV). Finally, Digit Symbol Substitution Test (DSST; WAIS-IV) will be used to measure processing speed.
8 secondary outcomes
Change in emotional distress
Time frame: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months
Change in Medication adherence
Time frame: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months
Change in Quality of Life
Time frame: Assessment will be conducted at baseline and at 12 months
Post-traumatic Stress
Time frame: Assessment will be conducted at baseline and at 12 months
Changes in Work role functioning
Time frame: Assessment will be conducted at baseline and at 12 months
Changes in Health Literacy
Time frame: Assessment will be conducted at baseline and at 12 months
Intervention Satisfaction
Time frame: Assessment will be conducted at 3 months
ICOnnecta't / ICOgnition App Usability
Time frame: Assessment will be conducted at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 27278814O'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.
- Background: PubMed 32505665Eide 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.
- Background: PubMed 22927526Jim 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.
- Background: PubMed 16410227Stewart 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.
- Background: PubMed 31617564Lange 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.
- Background: PubMed 33081111Boscher 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.
- Background: PubMed 34498828Mackenzie 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.
- Background: PubMed 27529826Treanor CJ, McMenamin UC, O'Neill RF, Cardwell CR, Clarke MJ, Cantwell M, Donnelly M. Non-pharmacological interventions for cognitive impairment due to systemic cancer treatment. Cochrane Database Syst Rev. 2016 Aug 16;2016(8):CD011325. doi: 10.1002/14651858.CD011325.pub2.
- Background: PubMed 31587187Kim Y, Kang SJ. Computerized programs for cancer survivors with cognitive problems: a systematic review. J Cancer Surviv. 2019 Dec;13(6):911-920. doi: 10.1007/s11764-019-00807-4. Epub 2019 Oct 5.
- Background: PubMed 34680310Binarelli G, Joly F, Tron L, Lefevre Arbogast S, Lange M. Management of Cancer-Related Cognitive Impairment: A Systematic Review of Computerized Cognitive Stimulation and Computerized Physical Activity. Cancers (Basel). 2021 Oct 14;13(20):5161. doi: 10.3390/cancers13205161.
- Background: PubMed 34638354Binarelli G, Lange M, Dos Santos M, Grellard JM, Lelaidier A, Tron L, Lefevre Arbogast S, Clarisse B, Joly F. Multimodal Web-Based Intervention for Cancer-Related Cognitive Impairment in Breast Cancer Patients: Cog-Stim Feasibility Study Protocol. Cancers (Basel). 2021 Sep 28;13(19):4868. doi: 10.3390/cancers13194868.
- Background: PubMed 32359500Penedo FJ, Oswald LB, Kronenfeld JP, Garcia SF, Cella D, Yanez B. The increasing value of eHealth in the delivery of patient-centred cancer care. Lancet Oncol. 2020 May;21(5):e240-e251. doi: 10.1016/S1470-2045(20)30021-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian Ochoa Arnedo, PhD principal investigator
Institut Català d'Oncologia
Questions about this trial
What is this clinical trial studying?
A study testing ICOgnition in people with Breast Cancer and Cognitive Dysfunction, run by Institut Català d'Oncologia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Serra Blasco, PhD (+34 93 260 78 00, mariaserrab@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjective cognition (time frame: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06103318, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.