Menu
Not yet recruiting NCT07017530

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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive training, Psychoeducational therapy.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Combined Intervention of Cognitive Training and Supervised Physical Exercise for Women With Breast Cancer and Chemotherapy-Related Cognitive Impairment: Study Protocol for a Randomized Controlled Trial

Overview

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.

Interventions

  • Other Cognitive training
    Combined Intervention of Cognitive Training and Supervised Physical Exercise
  • Other Psychoeducational therapy
    According to standard clinical practice

Primary outcome measures

  • Subjetive Cognitive function [Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
  • Objective Cognitive Function [Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
Secondary outcome measures (11)
  • Fatigue [Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
  • Sleep quality [Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
  • Insomnia [Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
  • Psychological distress [Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
  • Quality of life (QoL) [Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
  • Abdominal flexor endurance [Time frame: - Baseline - 12 weeks for intervention group]
  • Upper body and back muscular strength [Time frame: - Baseline - 12 weeks for intervention group]
  • Lower body endurance [Time frame: - Baseline - 12 weeks for intervention group]
  • Perceived physical fitness [Time frame: - Baseline - 12 weeks for intervention group]
  • Functional exercise capacity [Time frame: - Baseline - 12 weeks for intervention group]
  • Perceived effort [Time frame: - 12 weeks for intervention group]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Facultad de Medicina y Ciencias de la Salud — Badajoz

Identifiers

NCT: NCT07017530 · CEI 044/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗