Clinical trial NCT06103318: eHealth Interventions for Breast Cancer Cognitive Impairment
Official title: Cognitive Rehabilitation and Psychosocial Intervention Through a Stepped Digital Ecosystem in Breast Cancer: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Cognitive Dysfunction
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
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
Collaborators: name: Institut d'Investigació Biomèdica de Bellvitge
name: Carlos III Health Institute
First posted: 2023-10-26
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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

Primary outcomes:
measure: Change in Subjective cognition
timeFrame: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months
measure: Change in Objective Cognition (Digital assessment)
timeFrame: Assessment will be conducted at baseline and at 12 months
measure: Change in Objective Cognition (Paper and pencil assessment)
timeFrame: Assessment will be conducted at baseline and at 12 months
Secondary outcomes:
measure: Change in emotional distress
timeFrame: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months
measure: Change in Medication adherence
timeFrame: Assessment will be conducted at baseline and at 3 months, 6 months and 12 months
measure: Change in Quality of Life
timeFrame: Assessment will be conducted at baseline and at 12 months
measure: Post-traumatic Stress
timeFrame: Assessment will be conducted at baseline and at 12 months
measure: Changes in Work role functioning
timeFrame: Assessment will be conducted at baseline and at 12 months
measure: Changes in Health Literacy
timeFrame: Assessment will be conducted at baseline and at 12 months
measure: Intervention Satisfaction
timeFrame: Assessment will be conducted at 3 months
measure: ICOnnecta't / ICOgnition App Usability
timeFrame: Assessment will be conducted at 3 months
Other outcomes:
measure: Work absenteeism
timeFrame: 12 months post-intervention
measure: Professionals' salaries
timeFrame: 12 months post-intervention
measure: Infrastructure costs
timeFrame: 12 months post-intervention
measure: Psychotropic Medication
timeFrame: 12 months post-intervention
Locations:
Study officials:
affiliation: Institut Català d'Oncologia
name: Cristian Ochoa Arnedo, PhD
role: PRINCIPAL_INVESTIGATOR
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