Research on New Methods and New Models of Rehabilitation Intervention for Cancer Patients Based on Exercise and Psychological Intervention

NCT07317765 | Active Not Recruiting DMC

• 1 other identifier: 2022-2G-4029
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized Controlled Trial of Natural Psychotherapy for Intervening Negative Emotions in 100 Breast Cancer Patients

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• SAS score

  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.

  5 weeks

• SDS score

  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.

  5 weeks

Secondary Outcomes (4)

• Ruminative Response Scale

  5 weeks

• Connor-Davidson Resilience Scale

  5 weeks

• Functional Assessment of Cancer Therapy-Breast (FACT-B)

  5 weeks

• ACC score

  5 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

Other: Natural Psychotherapy

control group

OTHER

Other: Receive routine psychotherapy and read popular science materials related to breast cancer.

Interventions

Receive routine psychotherapy and read popular science materials related to breast cancer. OTHER

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

control group

Natural Psychotherapy OTHER

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.

intervention group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing HuiLongGuan Hospital: lead

Study Sites (1)

San Huan Cancer Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 5, 2026
• Study Start: March 17, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)