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

NCT ID: NCT07017530

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive training + exercise group during chemotherapy

Al list two cycles of chemotherapy.

Group Type: EXPERIMENTAL

Cognitive training

Intervention Type: OTHER

Combined Intervention of Cognitive Training and Supervised Physical Exercise

Cognitive training + exercise group after chemotherapy

Al list six months after the completion of chemotherapy.

Group Type: EXPERIMENTAL

Cognitive training

Intervention Type: OTHER

Combined Intervention of Cognitive Training and Supervised Physical Exercise

Psychoeducational therapy during chemotherapy

Al list two cycles of chemotherapy.

Group Type: ACTIVE_COMPARATOR

Psychoeducational therapy

Intervention Type: OTHER

According to standard clinical practice

Psychoeducational therapy after chemotherapy

Al list six months after the completion of chemotherapy.

Group Type: ACTIVE_COMPARATOR

Psychoeducational therapy

Intervention Type: OTHER

According to standard clinical practice

Interventions

Cognitive training

Combined Intervention of Cognitive Training and Supervised Physical Exercise

Intervention Type: OTHER

Psychoeducational therapy

According to standard clinical practice

Intervention Type: OTHER

Other Intervention Names

Adapted physical activity

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Extremadura

OTHER

Sponsor Role: lead

Responsible Party

Noelia Durán

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Facultad de Medicina y Ciencias de la Salud

Badajoz, Badajoz, Spain

Countries

Spain

Central Contacts

Noelia Durán-Gómez, PhD

Role: CONTACT

nduran@unex.es

+34924289466

Facility Contacts

Noelia Durán-Gómez

Role: primary

nduran@unex.es

+34924289466

Other Identifiers

CEI 044/23

Identifier Type: -

Identifier Source: org_study_id