eHealth Interventions for Breast Cancer Cognitive Impairment

NCT06103318 | Not Yet Recruiting

• 2 other identifiers: PI22/01255PR270/22
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (8)

• Change in emotional distress

  Assessment will be conducted at baseline and at 3 months, 6 months and 12 months

• Change in Medication adherence

  Assessment will be conducted at baseline and at 3 months, 6 months and 12 months

• Change in Quality of Life

  Assessment will be conducted at baseline and at 12 months

• Post-traumatic Stress

  Assessment will be conducted at baseline and at 12 months

• Changes in Work role functioning

  Assessment will be conducted at baseline and at 12 months

Other Outcomes (4)

• Work absenteeism

  12 months post-intervention

• Professionals' salaries

  12 months post-intervention

• Infrastructure costs

  12 months post-intervention

Study Arms (2)

ICOnnectat

ACTIVE COMPARATOR

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.

Behavioral: ICOgnition

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: 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.

Behavioral: ICOgnition

Interventions

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.

Also known as: Psychoeducational and Cognitive Training

ICOgnition; ICOnnectat

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women within 6 weeks after a Breast Cancer diagnosis
• Having online access and a user-level knowledge of the internet
• Understanding of Spanish language

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Català d'Oncologia: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator
• Carlos III Health Institute: collaborator

Related Publications (21)

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  PMID: 27278814 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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• 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.

  PMID: 22927526 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.

  PMID: 16410227 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.

  PMID: 31617564 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.

  PMID: 33081111 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.

  PMID: 34498828 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.

  PMID: 27529826 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.

  PMID: 31587187 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.

  PMID: 34680310 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.

  PMID: 34638354 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.

  PMID: 32359500 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.

  PMID: 35205722 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.

  PMID: 31803117 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.

  PMID: 35954388 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.

  PMID: 35320617 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.

  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.

  PMID: 33287685 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.

  PMID: 33638633 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.

  PMID: 32514643 BACKGROUND

• 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.

  PMID: 39070895 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Cognitive Dysfunction; Chemotherapy-Related Cognitive Impairment

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Cristian Ochoa Arnedo, PhD

  Institut Català d'Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Clinical Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 26, 2023
• Study Start: March 14, 2024
• Primary Completion: April 7, 2025
• Study Completion: September 7, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share