Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Substance Related Disorders

Breast Neoplasms

Cognitive Dysfunction

Chemotherapy-Related Cognitive Impairment

Breast Diseases

Skin Diseases

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Quality of Life

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.

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.

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.

ICOgnition

Maria Serra Blasco, PhD

Arnau Souto Sampera, MSc

Cristian Ochoa Arnedo, PhD

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.

  * 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).

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.

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.

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.

eHealth Interventions for Breast Cancer Cognitive Impairment

Cognitive Rehabilitation and Psychosocial Intervention Through a Stepped Digital Ecosystem in Breast Cancer: A Randomized Clinical Trial.

Number of days of patients' sick leaves (Electronic Health Record).

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).

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.

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.

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.

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.

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.

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

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.

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.

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

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.

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 ".

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".

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"

Institut d'Investigació Biomèdica de Bellvitge

Carlos III Health Institute

Institut Català d'Oncologia

PhD, Clinical Psychologist

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Invitation letter to the screening program with the FIT test

Prior notification to the new entrants, followed by an invitation letter to the screening program with the FIT test

Invitation letter to visit its own GP who will deliver the FIT test

The individuals eligible for the colorectal cancer screening program will receive at home an invitation letter to participate to the program along with a FIT test. The follow-up will be similar to the standard of care, i.e. reminder letters at 5 and 10 months if there is no participation, and reminders if no coloscopy after a positive FIT test

Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program

Dispatch of a notification, one month prior the dispatch of the screening test along the invitation letter. This intervention is among the new entrants to the national program

Sending of a prior notification to the new entrants of the national program

Maurice TANGUY, MD

Myriam GUERBAZ SOMMI, MD

Jean BOTO KEKY, MD

This is a randomized controlled trial comparing the effect on participation rates to colorectal cancer screening between an intervention arm (invitation letter to the screening program including a FIT test with or without prior notification) and a control arm with the standard of care (invitation letter to visit the GP who will deliver the FIT test).

The participation to the national screening program for colorectal cancer in France is low. In order to improve the performances of its organized program, the National Cancer Institute is planning to modify the invitation procedure. This is a pilot project and if an improvement in the program performances is reported, the invitation procedure may be scaled up.

Eligible individuals for colorectal cancer screening will be identified by the Regional Cancer Screening Coordinating Centre and randomized into the intervention or control arms. They will be followed for FIT test submission to the central laboratory (participation to screening). Those who did not send their test will receive reminder letters. Those who had a positive FIT test will be followed up for coloscopy referral, and result of the coloscopy. Comparison of the participation rates to screening program and to coloscopy among those with a positive FIT test will be compared between the two study arms.

This is a three-arm study with a parallel study design

Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program

Evaluation of the Home Delivery of the Screening Kit, and Impact of a Prior Notification Among New Participants to the National Organized Colorectal Cancer Screening Program (Among New Participants Only)

Comparison of the participation rate to the screening program between the intervention and the control arms

Comparison of the referral rates to coloscopy between the intervention and the control arms

Comparison of the participation rates to the screening program between the individuals aged 50-52 of the Intervention1 and the Intervention sub-study arms

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
eHealth Interventions for Breast Cancer Cognitive Impairment	NCT06103318	Breast Cancer Cognitive Dysfu...	ICOgnition	18 Years - 65 Years	Institut Català d'Oncologia
Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program	NCT05589675	Colorectal Canc...	Dispatch of the... Sending of a pr...	50 Years - 74 Years	International Agency for Research on Cancer

Spots Global Cancer Trial Database for randomised control trial