eHealth Interventions for Breast Cancer Cognitive Impairment (ICOgnition)
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ClinicalTrials.gov Identifier: NCT06103318 |
Recruitment Status :
Not yet recruiting
First Posted : October 26, 2023
Last Update Posted : March 6, 2024
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Cognitive Dysfunction | Behavioral: ICOgnition | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 176 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | Cognitive Rehabilitation and Psychosocial Intervention Through a Stepped Digital Ecosystem in Breast Cancer: A Randomized Clinical Trial. |
Estimated Study Start Date : | March 14, 2024 |
Estimated Primary Completion Date : | April 7, 2025 |
Estimated Study Completion Date : | September 7, 2025 |
Arm | Intervention/treatment |
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Active Comparator: ICOnnectat
ICOnnecta't is a stepped-care digital intervention tailored to breast cancer patients' psychosocial needs. It consists of four levels:
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Behavioral: ICOgnition
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. Other Name: Psychoeducational and Cognitive Training |
Experimental: ICOgnition
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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Behavioral: ICOgnition
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. Other Name: Psychoeducational and Cognitive Training |
- 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.
- Change in emotional distress [ Time Frame: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months ]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
- Change in Medication adherence [ Time Frame: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months ]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.
- Change in Quality of Life [ Time Frame: Assessment will be conducted at baseline and at 12 months ]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.
- Post-traumatic Stress [ Time Frame: Assessment will be conducted at baseline and at 12 months ]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
- Changes in Work role functioning [ Time Frame: Assessment will be conducted at baseline and at 12 months ]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.
- Changes in Health Literacy [ Time Frame: Assessment will be conducted at baseline and at 12 months ]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 [ Time Frame: Assessment will be conducted at 3 months ]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".
- ICOnnecta't / ICOgnition App Usability [ Time Frame: Assessment will be conducted at 3 months ]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"
- Work absenteeism [ Time Frame: 12 months post-intervention ]Number of days of patients' sick leaves (Electronic Health Record).
- Professionals' salaries [ Time Frame: 12 months post-intervention ]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).
- Infrastructure costs [ Time Frame: 12 months post-intervention ]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.
- Psychotropic Medication [ Time Frame: 12 months post-intervention ]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.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women within 6 weeks after a Breast Cancer diagnosis
- Having online access and a user-level knowledge of the internet
- Understanding of Spanish language
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06103318
Contact: Maria Serra Blasco, PhD | +34 93 260 78 00 | mariaserrab@iconcologia.net | |
Contact: Arnau Souto Sampera, MSc | +34 675 786 787 | arnausouto_ext@iconcologia.net |
Principal Investigator: | Cristian Ochoa Arnedo, PhD | Institut Català d'Oncologia |
Responsible Party: | Cristian Ochoa Arnedo, PhD, Clinical Psychologist, Institut Català d'Oncologia |
ClinicalTrials.gov Identifier: | NCT06103318 |
Other Study ID Numbers: |
PI22/01255 PR270/22 ( Other Identifier: Research Ethics Committee of Bellvitge University Hospital ) |
First Posted: | October 26, 2023 Key Record Dates |
Last Update Posted: | March 6, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
eHealth Breast Cancer Cancer Related Cognitive Impairment (CRCI) Chemobrain Psychoeducation Cognitive Training |
Emotional distress Randomised Control Trial Psycho-oncology Digital Health Quality of Life |
Breast Neoplasms Cognitive Dysfunction Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Cognition Disorders Neurocognitive Disorders Mental Disorders |