Breast CancerNCT07317765
Research on New Methods and New Models of Rehabilitation Intervention for Cancer Patients Based on Exercise and Psychological Intervention
A study testing Natural Psychotherapy and Receive routine psychotherapy and read popular science materials related to breast cancer. in people with Breast Cancer, run by Beijing HuiLongGuan Hospital at 1 site in China.
Trial summary
A Randomized Controlled Trial of Natural Psychotherapy for Intervening Negative Emotions in 100 Breast Cancer Patients Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Natural Psychotherapy and Receive routine psychotherapy and read popular science materials related to breast cancer.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
A Randomized Controlled Trial of Natural Psychotherapy for Intervening Negative Emotions in 100 Breast Cancer Patients
- Conditions
- Breast Cancer
- Being tested
- Natural Psychotherapy, Receive routine psychotherapy and read popular science materials related to breast cancer.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural PsychotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Other: Natural Psychotherapy |
| control group | Other | Not described Receives: Other: Receive routine psychotherapy and read popular science materials related to breast cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 5 weeks
ACC score
Acceptance and Commitment Questionnaire Score Range: Total scores range from 7 to 49 Interpretation: Higher scores indicate lower psychological flexibility
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start17 Mar 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing HuiLongGuan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Yang Zhang, Beijing HuiLongGuan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317765
- Sponsor's protocol ID
- 2022-2G-4029
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data with be available on request
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on New Methods and New Models of Rehabilitation Intervention for Cancer Patients Based on Exercise and Psychological Intervention
- ClinicalTrials.gov ID
- NCT07317765
- Acronym / sponsor ID
- 2022-2G-4029
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing HuiLongGuan HospitalUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized Controlled Trial of Natural Psychotherapy for Intervening Negative Emotions in 100 Breast Cancer Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Natural Psychotherapy |
| control group | Other | Other: Receive routine psychotherapy and read popular science materials related to breast cancer. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural PsychotherapyA 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 | intervention group |
| 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 | Other | control group |
Primary outcome
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.
4 secondary outcomes
Ruminative Response Scale
Time frame: 5 weeks
Connor-Davidson Resilience Scale
Time frame: 5 weeks
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Time frame: 5 weeks
ACC score
Time frame: 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No. Data with be available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Psychotherapy and Receive routine psychotherapy and read popular science materials related to breast cancer. in people with Breast Cancer, run by Beijing HuiLongGuan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAS score (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.