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Efficacy of Combined Cognitive Training and Biofeedback Therapy on Cognitive Function in Breast Cancer Patients Undergoing Radiotherapy

Efficacy of Combined Cognitive Training and Biofeedback Therapy on Cognitive Function in Breast Cancer Patients Undergoing Radiotherapy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112199
Enrollment
Unknown
Registered
2025-11-11
Start date
2021-12-21
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer-related cognitive impairment

Interventions

Combined Treatment Group:Participants will receive one session of cognitive training targeting different cognitive domains and undergo biofeedback therapy once daily.
Biofeedback Therapy Group:Participants will receive biofeedback therapy once daily.

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
27 Years to 67 Years

Inclusion criteria

Inclusion criteria: (1) Female patients aged 18 to 70 years. (2) Pathologically confirmed invasive breast carcinoma. (3) Have undergone breast-conserving surgery and are eligible for adjuvant radiotherapy. (4) Have completed at least 4 to 6 cycles of standard neoadjuvant and/or adjuvant chemotherapy containing taxanes and/or anthracyclines. (5) Have signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of malignancy or concurrent malignant tumors. (2) Patients who have previously received radiotherapy to the breast or chest area. (3) Pregnant or breastfeeding women. (4) Patients with a prior confirmed diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychiatric disorders secondary to medical conditions. (5) Illiterate patients, color-blind individuals, or those with severe impairments in hearing, speech, reading, or writing. (6) Patients who are unable to comply with follow-up requirements.

Design outcomes

Primary

MeasureTime frame
Eye-movement Assessment;Niacin Skin Flush Test;Perceived Deficits Questionnaire–5;Auditory Verbal Learning Test – Delayed Recall;Trail Making Test-A;Trail Making Test-B;Digit Span Test;Coding Test;

Secondary

MeasureTime frame
EORTC-QLQ-C30;EORTC-QLQ-BR23;Generalized Anxiety Disorder-7;Patient Health Questionnaire-9;Patient Health Questionnaire-15;Pittsburgh Sleep Quality Index;Mood Disorder Questionnaire;Eysenck Personality Questionnaire;Visual Analogue Scale;

Countries

China

Contacts

Public ContactFeng Wei

Fudan University Shanghai Cancer Center

ffww06@163.com+86 181 1629 5227

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026