Breast Cancer
Conditions
Brief summary
A Randomized Controlled Trial of Natural Psychotherapy for Intervening Negative Emotions in 100 Breast Cancer Patients
Interventions
A short-term psychological intervention of natural psychotherapy will be conducted for breast cancer patients over a five-week period, using a hybrid online and offline format. The first intervention session will be delivered offline, followed by online video-based sessions thereafter.
OTHERReceive routine psychotherapy and read popular science materials related to breast cancer.
This intervention (routine psychotherapy plus breast cancer popular science materials) is used in control group studies for data comparison purposes, serving as a baseline to evaluate the efficacy of the experimental intervention
Sponsors
Beijing HuiLongGuan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with pathologically confirmed breast cancer, no distant metastasis, who have completed the perioperative period and not received subsequent treatment; * Aged 18-59 years with an expected survival period of ≥ 1 year; * Breast cancer patients with a self-reported depression score of ≥ 53 and/or anxiety score of ≥ 50 on self-rating scales (e.g., Self-Rating Depression Scale \[SDS\], Self-Rating Anxiety Scale \[SAS\]); * Voluntarily participating in the study after providing informed consent and signing the informed consent form.
Exclusion criteria
* Patients with advanced breast cancer (stage IV with distant metastasis); * Patients receiving other psychological interventions besides this study (e.g., individual counseling, group therapy); * Patients with severe mental illness (e.g., schizophrenia), cognitive impairment (MMSE score \< 24), heart disease, severe physical illness, other cancers, or complications; * Patients who are unable to cooperate with psychological interventions, questionnaires, or interviews; patients who request or voluntarily withdraw from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SAS score | 5 weeks | Self-Rating Anxiety Scale (SAS) Score range: The total score ranges from 20 to 80 after standard conversion. Interpretation of scores: Higher scores indicate more severe anxiety symptoms; conversely, lower scores reflect milder or no anxiety symptoms. |
| SDS score | 5 weeks | Self-Rating Depression Scale (SDS) Score range: The total score ranges from 20 to 80 after standard conversion. Interpretation of scores: Higher scores represent more severe depressive symptoms; on the contrary, lower scores mean less severe or no depressive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ruminative Response Scale | 5 weeks | Ruminative Response Scale Score Range: Total scores range from 22 to 88 Score Interpretation: Higher scores indicate more frequent and severe ruminative thinking patterns, which are associated with increased risk of negative emotional states such as depression and anxiety. |
| Connor-Davidson Resilience Scale | 5 weeks | Connor-Davidson Resilience Scale Score Range: Total scores range from 0 to 100 Score Interpretation: Higher scores reflect greater psychological resilience, meaning better ability to cope with adversity, stress, and trauma. |
| Functional Assessment of Cancer Therapy-Breast (FACT-B) | 5 weeks | Functional Assessment of Cancer Therapy-Breast Score Range: Total scores range from 0 to 144 Score Interpretation: Higher scores represent better health-related quality of life in breast cancer patients, covering physical well-being, social/family well-being, emotional well-being, and functional well-being specific to breast cancer. |
| ACC score | 5 weeks | Acceptance and Commitment Questionnaire Score Range: Total scores range from 7 to 49 Interpretation: Higher scores indicate lower psychological flexibility |
Countries
China
Outcome results
None listed