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| ID | Type | Description | Link |
|---|---|---|---|
| PR270/22 | Other Identifier | Research Ethics Committee of Bellvitge University Hospital |
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| Name | Class |
|---|---|
| Institut d'Investigació Biomèdica de Bellvitge | OTHER |
| Carlos III Health Institute | OTHER_GOV |
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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.
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).
o Study Sample
The study will include 176 female breast cancer patients in the acute survival phase from ICO Hospitalet.
o 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.
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).
o 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICOnnectat | Active Comparator | ICOnnecta't is a stepped-care digital intervention tailored to breast cancer patients' psychosocial needs. It consists of four levels:
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICOgnition | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Assessment will be conducted at baseline and at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessment will be conducted at baseline and at 3 months, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Work absenteeism | Number of days of patients' sick leaves (Electronic Health Record). | 12 months post-intervention |
| Professionals' salaries | Number of professionals involved in the ICOnnecta't treatment or ICOnnecta't + ICOgnition platform as well as the number of professionals' working hours per week and costs (Electronic Health Record). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Serra Blasco, PhD | Contact | +34 93 260 78 00 | mariaserrab@iconcologia.net | |
| Arnau Souto Sampera, MSc | Contact | +34 675 786 787 | arnausouto_ext@iconcologia.net |
| Name | Affiliation | Role |
|---|---|---|
| Cristian Ochoa Arnedo, PhD | Institut Català d'Oncologia | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27278814 | Background | 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. | |
| 32505665 | Background | Eide 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D060825 | Cognitive Dysfunction |
| D000084202 | Chemotherapy-Related Cognitive Impairment |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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.
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To implement masking in the outcome assessor, the study will use an external service, the Biostatistical Services of The Bellvitge Biomedical Research Institute (IDIBELL). This external service will collect information through online questionnaires using REDCap, a secure web platform. Using an external service will help maintain the integrity of the study and prevents potential biases. Blinding in this context ensures that the assessment of outcomes is conducted impartially and without any influence from knowledge about the treatment assignments.
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| 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. | 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. | 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 | 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. | 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 ". | 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". | 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" | Assessment will be conducted at 3 months |
| 12 months post-intervention |
| Infrastructure costs | Costs per user and per month for the development and maintenance of the ICOnnecta't + ICOgnition platform (experimental group) and costs of ICOnnecta't platform alone per user and month. | 12 months post-intervention |
| Psychotropic Medication | First, the Electronic Health Record will be checked to collect psychotropic medication data for each group during the study. Second, the pharmacy service of ICO will calculate the medication costs. | 12 months post-intervention |
| 22927526 | Background | Jim 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. |
| 16410227 | Background | Stewart 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. |
| 31617564 | Background | Lange 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. |
| 33081111 | Background | Boscher 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. |
| 34498828 | Background | Mackenzie 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. |
| 27529826 | Background | Treanor 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. |
| 31587187 | Background | Kim 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. |
| 34680310 | Background | Binarelli 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. |
| 34638354 | Background | Binarelli 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. |
| 32359500 | Background | Penedo 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. |
| 35205722 | Background | Medina 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. |
| 31803117 | Background | Kaiser 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. |
| 35954388 | Background | Ciria-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. |
| 35320617 | Background | Fardell JE, Bray V, Bell ML, Rabe B, Dhillon H, Vardy JL. Screening for cognitive symptoms among cancer patients during chemotherapy: Sensitivity and specificity of a single item self-report cognitive change score. Psychooncology. 2022 Aug;31(8):1294-1301. doi: 10.1002/pon.5928. Epub 2022 Mar 30. |
| Background | Bell ML, Dhillon HM, Bray VJ, Vardy JL. Important differences and meaningful changes for the functional assessment of cancer therapy-cognitive function (FACT-COG). J Patient-Reported Outcomes 2018;2:48. |
| 33287685 | Background | Shari NI, Zainal NZ, Ng CG. Effects of brief acceptance and commitment therapy (ACT) on subjective cognitive impairment in breast cancer patients undergoing chemotherapy. J Psychosoc Oncol. 2021;39(6):695-714. doi: 10.1080/07347332.2020.1856283. Epub 2020 Dec 8. |
| 33638633 | Background | Henneghan AM, Van Dyk K, Kaufmann T, Harrison R, Gibbons C, Heijnen C, Kesler SR. Measuring Self-Reported Cancer-Related Cognitive Impairment: Recommendations From the Cancer Neuroscience Initiative Working Group. J Natl Cancer Inst. 2021 Nov 29;113(12):1625-1633. doi: 10.1093/jnci/djab027. |
| 32514643 | Background | Kennedy-Martin M, Slaap B, Herdman M, van Reenen M, Kennedy-Martin T, Greiner W, Busschbach J, Boye KS. Which multi-attribute utility instruments are recommended for use in cost-utility analysis? A review of national health technology assessment (HTA) guidelines. Eur J Health Econ. 2020 Nov;21(8):1245-1257. doi: 10.1007/s10198-020-01195-8. Epub 2020 Jun 8. |
| 39070895 | Derived | Serra-Blasco M, Souto-Sampera A, Medina JC, Flix-Valle A, Ciria-Suarez L, Arizu-Onassis A, Ruiz-Romeo M, Jansen F, Rodriguez A, Pernas S, Ochoa-Arnedo C. Cognitive-enhanced eHealth psychosocial stepped intervention for managing breast cancer-related cognitive impairment: Protocol for a randomized controlled trial. Digit Health. 2024 Jul 25;10:20552076241257082. doi: 10.1177/20552076241257082. eCollection 2024 Jan-Dec. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |