Cognitive Training and Exercise for Women With Breast Cancer and Cognitive Impairment

NCT07017530 | Not Yet Recruiting DMC

• 1 other identifier: CEI 044/23
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy-related cognitive impairment is a prevalent and distressing condition among breast cancer survivors, adversely affecting memory, attention, and overall cognitive function, thereby diminishing quality of life. Emerging evidence suggests that multimodal interventions combining cognitive training and adapted physical exercise may mitigate these cognitive deficits and associated symptoms. This study aims to evaluate the efficacy of a 12-week structured intervention integrating cognitive training and supervised physical exercise in improving cognitive function, fatigue, sleep quality, psychological distress, and overall well-being in women with breast cancer. Furthermore, it seeks to determine the optimal timing for such interventions to maximize their effectiveness. A randomized controlled trial involving 220 participants will assess subjective and objective cognitive outcomes, brain activity, and physical performance. The findings from this research may contribute to the development of evidence-based rehabilitation strategies, enhancing cognitive health and quality of life in breast cancer patients.

Conditions

Breast Cancer

Keywords

Breast cancer; Chemotherapy-Related Cognitive Impairment; Cognitive Training; Exercise; Oncology Nursing

Outcome Measures

Primary Outcomes (2)

• Subjetive Cognitive function

  It will be assessed using subjective cognitive function measured by Functional Assessment of Cancer Therapy-Cognition (FACT-Cog) scale.

  - Baseline - 12 weeks for intervention group - 16 weeks for control group

• Objective Cognitive Function

  It will be assessed with Near Infrared Spectroscopy (regional cerebral oxygen saturation).

  - Baseline - 12 weeks for intervention group - 16 weeks for control group

Secondary Outcomes (11)

• Fatigue

  - Baseline - 12 weeks for intervention group - 16 weeks for control group

• Sleep quality

  - Baseline - 12 weeks for intervention group - 16 weeks for control group

• Insomnia

  - Baseline - 12 weeks for intervention group - 16 weeks for control group

• Psychological distress

  - Baseline - 12 weeks for intervention group - 16 weeks for control group

• Quality of life (QoL)

  - Baseline - 12 weeks for intervention group - 16 weeks for control group

Study Arms (4)

Cognitive training + exercise group during chemotherapy

EXPERIMENTAL

Al list two cycles of chemotherapy.

Other: Cognitive training

Cognitive training + exercise group after chemotherapy

EXPERIMENTAL

Al list six months after the completion of chemotherapy.

Other: Cognitive training

Psychoeducational therapy during chemotherapy

ACTIVE COMPARATOR

Al list two cycles of chemotherapy.

Other: Psychoeducational therapy

Psychoeducational therapy after chemotherapy

ACTIVE COMPARATOR

Al list six months after the completion of chemotherapy.

Other: Psychoeducational therapy

Interventions

Cognitive training OTHER

Combined Intervention of Cognitive Training and Supervised Physical Exercise

Also known as: Adapted physical activity

Cognitive training + exercise group after chemotherapy; Cognitive training + exercise group during chemotherapy

Psychoeducational therapy OTHER

According to standard clinical practice

Psychoeducational therapy after chemotherapy; Psychoeducational therapy during chemotherapy

Eligibility Criteria

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

You may qualify if:

• Women aged 18 years or older who were diagnosed with stage 0 to IV breast cancer.
• Women undergoing chemotherapy (at least two cycles) or having completed it at least six months earlier.
• Cognitive impairment must be reported, with scores below 54 on the FACT-Cog scale

You may not qualify if:

• Women with significant neurological conditions.
• Women with psychiatric conditions.
• Women with contraindications for physical exercise.

Sponsors & Collaborators

• Universidad de Extremadura: lead

Study Sites (1)

Facultad de Medicina y Ciencias de la Salud

Badajoz, Badajoz, 06006, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Chemotherapy-Related Cognitive Impairment; Motor Activity

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Noelia Durán-Gómez, PhD

CONTACT

+34924289466; nduran@unex.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)