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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Natural Psychotherapy; Other: Receive routine psychotherapy and read popular science materials related to breast cancer.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • San Huan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group	Other: Natural Psychotherapy; 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.
Other: control group	Other: Receive 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ruminative Response Scale	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.	5 weeks
Connor-Davidson Resilience Scale	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.	5 weeks
Functional Assessment of Cancer Therapy-Breast (FACT-B)	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.	5 weeks
ACC score	Acceptance and Commitment Questionnaire Score Range: Total scores range from 7 to 49 Interpretation: Higher scores indicate lower psychological flexibility	5 weeks

Collaborators and Investigators

• Sponsor: Beijing HuiLongGuan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2022-2G-4029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data with be available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No