Breast Cancer FemaleNCT04442035
5-element Music Therapy on Patients With Breast Cancer
A study testing 5-element music therapy in people with Breast Cancer Female and Quality of Life, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
In this study, we observed the clinical effect of using music therapy of TCM to improve the status of liver depression in patients with postoperative breast cancer patients, Second we want to explore the efficacy and advantages of traditional Chinese medicine in patients with postoperative breast cancer, and to reveal… Read more about this study
- Who is it for?
- Ages 27 to 66 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female, Quality of Life, Depression, Anxiety
- What is being tested?
- 5-element music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2017to 3 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 27 to 66 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the diagnosis of breast cancer in clinical stage (Ⅰ, Ⅱ, Ⅲ) and postoperative breast cancer during one month;
- All participants had to have clinical depression and stagnation of liver qi;
- age 27-66;
- participants are conscious and willing to be followed up during the treatment.
Who cannot join
- Metastasis of breast cancer or serious complications;
- Patients with major depressive disorder;
- The past medical history of mental disorders;
- The primary diseases including liver, kidney, cerebrovascular, cardiovascular and hematopoietic system diseases;
- Participating in another clinical study or undergoing another intervention;
- Patients with hearing loss.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Chinese medicine hospital
Guangzhou, Guangdong, 510000
About this study
Official title: Clinical Efficacy Study on 5-element Music Therapy on Patients With Physically and Psychologically Unbalance After Breast Cancer Surgery
In this study, we observed the clinical effect of using music therapy of TCM to improve the status of liver depression in patients with postoperative breast cancer patients, Second we want to explore the efficacy and advantages of traditional Chinese medicine in patients with postoperative breast cancer, and to reveal the clinical use of the efficacy and superiority.
Read the detailed description
The study is a prospective controlled trial. Sixty-four patients were divided randomly into two groups. Patients were randomly divided into the treatment group and the control group, namely, the music treatment group and the health education group. The treatment group was given at least 30 minutes of individual music therapy and group music therapy every 3 weeks. Instead, the control group was given every 3 weeks of health education preach. It will take 12 weeks for treatment and observation. The efficacy was evaluated by observing the beginning and end of the trial of the Self-Rating Anxiety Scale score, the Self-Rating Depression Scale score, and the Breast Cancer Patients' Quality of Life Scale. At the end of the treatment, we take software packages SPSS 20.0 for management and statistical analysis.
- Conditions
- Breast Cancer Female, Quality of Life, Depression, Anxiety
- Being tested
- 5-element music therapy
- Keywords
- breast cancer, music therapy, Quality of Life, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-element music therapyBehavioural
Also called health education
participants were treated by TCM five-phase music therapy for not less than 30 minutes per day, and group music therapy was performed every three weeks. In addition, the therapeutic schedule is composed of treatment time (1pm-2pm, 9pm-11pm), frequency treatment (two times a day), intervention (10-15 minutes in the afternoon, 30 minutes in the evening) and content (individuals: dialectical selection of music; groups: community singing, every three weeks).
| Study group | Role | What they receive |
|---|---|---|
| The teatment group | Experimental | 5-element misic therapy Receives: Behavioral: 5-element music therapy |
| The control group | Experimental | health education Receives: Behavioral: 5-element music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Self-Rating Anxiety Scale (SAS) score at 3 Months
The SAS is validated,self-reported table assessing anxiety state over the past 3 month.Possible scores below 50 defined as no anxiety,range 50 to 59 is Mild anxiety,range 60 to 69 is Moderate anxiety , scores above 70 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )
Measured: Baseline and months 3
Change From Baseline in Self-Rating Depression Scale(SDS) score at 3 Months
The SDS is validated,self-reported table assessing depression state over the past 3 month.Possible scores below 52 defined as no anxiety,range 53 to 62 is Mild anxiety,range 63 to 72 is Moderate anxiety , scores above 73 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )
Measured: Baseline and months 3
Change From Baseline in Quality of Life (FACT-B score) at 3 Months
The FACT-B is validated,self-reported table assessing quality of life over the past 3 month. The scale evaluation breast cancer patient's quality of life for 5 - dimensional such as physiological, social\&family, emotions ; status ; breast cancer additional entries .
The higher the score , the better state change=( months 3 score -Baseline score )
Measured: Baseline and months 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start25 Mar 2017
- Primary completion24 Mar 2018
- Study completion3 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zheng zhuanfang, Study chair, Second Clinical College of Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442035
- Sponsor's protocol ID
- B2016-043-01
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy Study on 5-element Music Therapy on Patients With Physically and Psychologically Unbalance After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04442035
- Acronym / sponsor ID
- B2016-043-01
- Conditions
- Breast Cancer Female, Quality of Life, Depression, Anxiety
- Keywords
- breast cancer, music therapy, Quality of Life, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 25 Mar 2017 (actual)
- Primary completion
- 24 Mar 2018 (actual)
- Study completion
- 3 Jun 2018 (actual)
- First posted
- 22 Jun 2020 (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.
In this study, we observed the clinical effect of using music therapy of TCM to improve the status of liver depression in patients with postoperative breast cancer patients, Second we want to explore the efficacy and advantages of traditional Chinese medicine in patients with postoperative breast cancer, and to reveal the clinical use of the efficacy and superiority.
Detailed description
The study is a prospective controlled trial. Sixty-four patients were divided randomly into two groups. Patients were randomly divided into the treatment group and the control group, namely, the music treatment group and the health education group. The treatment group was given at least 30 minutes of individual music therapy and group music therapy every 3 weeks. Instead, the control group was given every 3 weeks of health education preach. It will take 12 weeks for treatment and observation. The efficacy was evaluated by observing the beginning and end of the trial of the Self-Rating Anxiety Scale score, the Self-Rating Depression Scale score, and the Breast Cancer Patients' Quality of Life Scale. At the end of the treatment, we take software packages SPSS 20.0 for management and statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The teatment group | Experimental | Behavioral: 5-element music therapy5-element misic therapy |
| The control group | Experimental | Behavioral: 5-element music therapyhealth education |
Who may qualify
- Ages
- 27 to 66 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the diagnosis of breast cancer in clinical stage (Ⅰ, Ⅱ, Ⅲ) and postoperative breast cancer during one month;
- All participants had to have clinical depression and stagnation of liver qi;
- age 27-66;
- participants are conscious and willing to be followed up during the treatment.
Key exclusion criteria (6 listed)
- Metastasis of breast cancer or serious complications;
- Patients with major depressive disorder;
- The past medical history of mental disorders;
- The primary diseases including liver, kidney, cerebrovascular, cardiovascular and hematopoietic system diseases;
- Participating in another clinical study or undergoing another intervention;
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 |
|---|---|---|
| 5-element music therapyAlso: health educationparticipants were treated by TCM five-phase music therapy for not less than 30 minutes per day, and group music therapy was performed every three weeks. In addition, the therapeutic schedule is composed of treatment time (1pm-2pm, 9pm-11pm), frequency treatment (two times a day), intervention (10-15 minutes in the afternoon, 30 minutes in the evening) and content (individuals: dialectical selection of music; groups: community singing, every three weeks). | Behavioural | The control group, The teatment group |
Primary outcome
Change From Baseline in Self-Rating Anxiety Scale (SAS) score at 3 Months
Time frame: Baseline and months 3
The SAS is validated,self-reported table assessing anxiety state over the past 3 month.Possible scores below 50 defined as no anxiety,range 50 to 59 is Mild anxiety,range 60 to 69 is Moderate anxiety , scores above 70 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )
Change From Baseline in Self-Rating Depression Scale(SDS) score at 3 Months
Time frame: Baseline and months 3
The SDS is validated,self-reported table assessing depression state over the past 3 month.Possible scores below 52 defined as no anxiety,range 53 to 62 is Mild anxiety,range 63 to 72 is Moderate anxiety , scores above 73 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )
Change From Baseline in Quality of Life (FACT-B score) at 3 Months
Time frame: Baseline and months 3
The FACT-B is validated,self-reported table assessing quality of life over the past 3 month. The scale evaluation breast cancer patient's quality of life for 5 - dimensional such as physiological, social\&family, emotions ; status ; breast cancer additional entries . The higher the score , the better state change=( months 3 score -Baseline score )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Zheng zhuanfang study chair
Second Clinical College of Guangzhou University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-element music therapy in people with Breast Cancer Female and Quality of Life, run by Guangzhou University of Traditional Chinese Medicine 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 6 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: finished, as of the sponsor's last update on 22 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change From Baseline in Self-Rating Anxiety Scale (SAS) score at 3 Months (time frame: Baseline and months 3). The study lists 3 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 22 Jun 2020.