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A prospective, randomized, controlled clinical study for the effect of art-making on quality of life and immune cell function in patients with early and middle stage invasive ductal carcinoma of the breast

A prospective, randomized, controlled clinical study for the effect of art-making on quality of life and immune cell function in patients with early and middle stage invasive ductal carcinoma of the breast

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025942
Enrollment
Unknown
Registered
2019-09-15
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-09-16

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

Conditions

breast cancer

Interventions

experimental group:art-making therapy
control group:NONE

Sponsors

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) have full capacity for civil conduct, fully understand and sign the informed consent; (2) patients with early and middle stage invasive breast cancer diagnosed by surgery without distant metastasis (T1-3N1-0M0); (3) aged 18-70 years, female patients; (4) the treatment of surgery, adjuvant chemotherapy and radiotherapy has been completed; Endocrine therapy and targeted therapy can be performed during the trial. (5) 0-2 points of physical condition on the ECOG scale; (6) heart function, liver function, renal function, blood system without obvious abnormalities.(ultrasound of the heart showed that the ejection fraction of the heart was within the normal range; 90 g/L or higher; WBC >= 3.5 x 109 / L; Platelet >= 100x10$9/L; Neutrophils >=1.5x10^9/L; AST <= 3 times normal upper limit; ALT <= 3 times normal upper limit; Bilirubin <= 1.5 times normal upper limit; Serum creatinine <= 1.5 times the normal upper limit).

Exclusion criteria

Exclusion criteria: (1) with other malignancies, or with malignancies except for breast cancer in the past 5 years, except for basal-cell or squamous-cell cancers of the skin that have been adequately treated and controlled, and carcinoma in situ of the cervix; (2) serious diseases with non-malignant tumors will affect patients' compliance or put patients in a dangerous state; Or severely physically disabled, affecting life (e.g. limb mutilation); (3) participating in other clinical trials; (4) patients with autoimmune diseases, chronic infectious inflammation, or severe acute infection during treatment; (5) illiterate or semi-literate, etc., music or art and other art-making without any desire to contact; (6) No psychiatric disorders diagnosed by psychiatrists, can understand the research process; (7) gestational breast cancer or breast-feeding breast cancer.

Design outcomes

Primary

MeasureTime frame
Quality of Life;Hospital Anxiety and Depression Scale;

Secondary

MeasureTime frame
Immune function of lymphocyte subsets;

Countries

China

Contacts

Public ContactYao Yandan

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

yaoyand@mail.sysu.edu.cn+86 13826292688

Outcome results

None listed

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