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NCT Number: NCT07317765

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Huan Cancer Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

  2. 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

  1. Ruminative Response Scale

    Time frame: 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.

  2. Connor-Davidson Resilience Scale

    Time frame: 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.

  3. Functional Assessment of Cancer Therapy-Breast (FACT-B)

    Time frame: 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.

  4. ACC score

    Time frame: 5 weeks

    Acceptance and Commitment Questionnaire Score Range: Total scores range from 7 to 49 Interpretation: Higher scores indicate lower psychological flexibility

Sponsors and collaborators

Lead sponsor

Beijing HuiLongGuan Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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