CancerNCT00964314
Traditional Chinese Medicine Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer
A study testing music in people with Cancer, run by Ministry of Science and Technology of the People´s Republic of China at 2 sites in China.
Trial summary
The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) five elements music therapy improving quality of life for patients with advanced cancer, as well as establishing the standard operating procedures (SOP) for it. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesChina
- Study dates
- Feb 2009to Oct 2011
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participation will be enrolled based on diagnostic criteria.
- Advanced cancer patient with more than 50 scores of Karnofsky Performance Score (KPS).
- Diagnosis of advanced cancer
- Patients who are willing to be subject with taking part in this research voluntarily.
- No prior experience with TCM music therapy.
- Newly admitted to TCM oncology department for 3 weeks treatment course.
Who cannot join
- Complicated diagnose or one who don't consistent with inclusion criteria.
- Patients suffering from psychosis or diagnosis, or psychiatric diagnoses (e.g., schizophrenia).
- Suffering from acute organ prostration or other condition of demanding to rescue，inability for accepting music therapy.
- One don't read or fill in diary owing to some causes, such as state of the art or acuity of vision
- One suffering from hearing disturbance
- Accepted TCM five elements music therapy in the past.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
Oncology Department of Xi Yuan hospital
Beijing, HaiDian District, 100091
About this study
Official title: Prospective Study With RCT Designed for Evaluation of TCM Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer
The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) five elements music therapy improving quality of life for patients with advanced cancer, as well as establishing the standard operating procedures (SOP) for it.
Read the detailed description
Design: As randomized controlled trial (RCT) with un-blinded design will be done.
- Conditions
- Cancer
- Being tested
- music
- Keywords
- advanced cancer, TCM five elements music therapy, quality of life (QOL)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
Experimental Group one : Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China.
Experimental Group two: Listening western music based on conventional therapy in China.
Control Group: no music therapy will be done.
| Study group | Role | What they receive |
|---|---|---|
| five elements music | Experimental | Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China. Receives: Other: music |
| western music | Active comparator | Listening western music based on conventional therapy in China. Receives: Other: music |
| Without music | No intervention | no music therapy will be done in the arm. Receives: Other: music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group).
Comparison of Qol, KPS, Diary at baseline and endpoint, the result shown here were significantly different for all terms in TCM five elements music group, p=0. p=0.0015, p=0.0015 respectively. However, no significant difference was seen for all terms in Western music group and the no music group respectively (See Table 3).
Measured: Difference of(pro-post)treatment for KPS,Qol, Diary
Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for the >70 year old group).
Comparison of Qol, KPS and Diary score at baseline and endpoint results show there was a significant difference for the QoL in TCM five elements music group, p value is 0.0062. However, there was no significant difference for the KPS and Diary score in each group respectively(See Table 4).
Measured: Difference of(pro-post)treatment for KPS,Qol, Diary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Liao Juan, Ministry of Science and Technology of the People´s Republic of China
- Investigators
- Yang Yu fei, doctor, Study director, Oncology department of Xi Yuan Hospital, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964314
- Sponsor's protocol ID
- WJB720603
- Status last verified
- Apr 2012
- First submitted
- 19 Aug 2009
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study With RCT Designed for Evaluation of TCM Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00964314
- Acronym / sponsor ID
- WJB720603
- Conditions
- Cancer
- Keywords
- advanced cancer, TCM five elements music therapy, quality of life (QOL)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Feb 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Aug 2009 (estimated)
- 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.
The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) five elements music therapy improving quality of life for patients with advanced cancer, as well as establishing the standard operating procedures (SOP) for it.
Detailed description
Design: As randomized controlled trial (RCT) with un-blinded design will be done.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| five elements music | Experimental | Other: musicListening TCM five elements music therapy（TCMMT）based on conventional therapy in China. |
| western music | Active comparator | Other: musicListening western music based on conventional therapy in China. |
| Without music | No intervention | Other: musicno music therapy will be done in the arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible participation will be enrolled based on diagnostic criteria.
- Advanced cancer patient with more than 50 scores of Karnofsky Performance Score (KPS).
- Diagnosis of advanced cancer
- Patients who are willing to be subject with taking part in this research voluntarily.
- No prior experience with TCM music therapy.
Key exclusion criteria (6 listed)
- Complicated diagnose or one who don't consistent with inclusion criteria.
- Patients suffering from psychosis or diagnosis, or psychiatric diagnoses (e.g., schizophrenia).
- Suffering from acute organ prostration or other condition of demanding to rescue，inability for accepting music therapy.
- One don't read or fill in diary owing to some causes, such as state of the art or acuity of vision
- One suffering from hearing disturbance
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 |
|---|---|---|
| musicExperimental Group one : Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China. Experimental Group two: Listening western music based on conventional therapy in China. Control Group: no music therapy will be done. | Other | Without music, five elements music, western music |
Primary outcome
Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group).
Time frame: Difference of(pro-post)treatment for KPS,Qol, Diary
Comparison of Qol, KPS, Diary at baseline and endpoint, the result shown here were significantly different for all terms in TCM five elements music group, p=0. p=0.0015, p=0.0015 respectively. However, no significant difference was seen for all terms in Western music group and the no music group respectively (See Table 3).
Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for the >70 year old group).
Time frame: Difference of(pro-post)treatment for KPS,Qol, Diary
Comparison of Qol, KPS and Diary score at baseline and endpoint results show there was a significant difference for the QoL in TCM five elements music group, p value is 0.0062. However, there was no significant difference for the KPS and Diary score in each group respectively(See Table 4).
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 23 Apr 2012.
- Related InfoLink provided by the sponsor.
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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.
Yang Yu fei, doctor study director
Oncology department of Xi Yuan Hospital, China Academy of Chinese Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music in people with Cancer, run by Ministry of Science and Technology of the People´s Republic of China at 2 sites 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 6 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 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group). (time frame: Difference of(pro-post)treatment for KPS,Qol, Diary). 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 23 Apr 2012.