NCT07317765Active, not recruitingNot Applicable
Research on New Methods and New Models of Rehabilitation Intervention for Cancer Patients Based on Exercise and Psychological Intervention
Beijing HuiLongGuan Hospital1 site in 1 country200 target enrollmentStarted: March 17, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Beijing HuiLongGuan Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- SAS score
Study Overview
Brief Summary
A Randomized Controlled Trial of Natural Psychotherapy for Intervening Negative Emotions in 100 Breast Cancer Patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- Female
- Accepts 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.
Outcomes
Primary Outcomes
SAS score
Time Frame: 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
Time Frame: 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 Outcomes
- Ruminative Response Scale(5 weeks)
- Connor-Davidson Resilience Scale(5 weeks)
- ACC score(5 weeks)
- Functional Assessment of Cancer Therapy-Breast (FACT-B)(5 weeks)
Investigators
Xiang Yang Zhang
Professor
Beijing HuiLongGuan Hospital
Study Sites (1)
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