Trial Title:
eHealth Interventions for Breast Cancer Cognitive Impairment
NCT ID:
NCT06103318
Condition:
Breast Cancer
Cognitive Dysfunction
Conditions: Official terms:
Breast Neoplasms
Cognitive Dysfunction
Conditions: 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
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
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.
Primary purpose:
Treatment
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.
Intervention:
Intervention type:
Behavioral
Intervention name:
ICOgnition
Description:
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.
Arm group label:
ICOgnition
Arm group label:
ICOnnectat
Other name:
Psychoeducational and Cognitive Training
Summary:
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).
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
March 14, 2024
Completion date:
September 7, 2025
Lead sponsor:
Agency:
Institut Català d'Oncologia
Agency class:
Other
Collaborator:
Agency:
Institut d'Investigació Biomèdica de Bellvitge
Agency class:
Other
Collaborator:
Agency:
Carlos III Health Institute
Agency class:
Other
Source:
Institut Català d'Oncologia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06103318
