Music Therapy, Breast Cancer, Anxiety, FatigueNCT04540471
Music Therapy in Patients With Breast Cancer- a Randomized Controlled Trial
A study testing music and comprehensive in-patient education program in people with Music Therapy, Breast Cancer, Anxiety, Fatigue, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Comprehensive inpatient rehabilitation for breast cancer consist of interdisciplinary team care but few researchers investigate the efficacy of music therapy, which have shown some benefits in breast cancer rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Music Therapy, Breast Cancer, Anxiety, Fatigue
- What is being tested?
- music and comprehensive in-patient education program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 31 Dec 2020
- 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
- We design this study as an assessor blinded, randomized, controlled, parallel group trial. The participants will be recruited from OPD unit of tertiary referral hospital in Southern Taiwan. Inclusion criteria will be as follows: (1) patients with breast cancer between 20~80 years old at stage (1-6 months post surgery) (2) able to follow basic orders (verbal or gesture) and tolerated music therapy by 1 hour.
Who cannot join
- Individuals will be excluded from the study if they are unable to cooperate with music therapy, are significantly hearing impaired, are severely mentally impaired (MMSE<10), or not agree to sign the informed consent, uncontrolled seizure or do not agree further evaluation. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Nursing, Chang Gang Memorial Hospital
Comprehensive inpatient rehabilitation for breast cancer consist of interdisciplinary team care but few researchers investigate the efficacy of music therapy, which have shown some benefits in breast cancer rehabilitation. According to previous research, music therapy has been proposed to improve quality of life, as well as depression and stress of breast cancer patients. However, to the best of our knowledge, only few studies have investigated the impact of music therapy among health-related parameter of patient with breast cancer. Considering the fact that music therapy had merely no adverse events, we assume music therapy is an optimal add-on therapy for patient with breast cancer. Therefore, we plan to conduct a study to evaluate the impact of music therapy on anxiety, and fatigue on patients with breast cancer.
Read the detailed description
Patients and Method:
We designed this study as an assessor blinded, randomized, controlled, parallel group trial. The participants will be recruited from general surgery unit of tertiary referral hospital in Southern Taiwan. Inclusion criteria will be as follows: (1) patients with first-ever breast cancer between 20~80 years old (1 to 6 months post- surgery) (2) able to follow basic orders (verbal or gesture) and tolerated music therapy by 1 hour. Individuals will be excluded from the study if they (1) are unable to cooperate with music therapy, (2) undergoing psychotherapeutic treatment during the study period, using antidepressants during the study period, (3) are significantly hearing impaired, not agree to sign the informed consent, or do not agree further evaluation, and (4) pregnant women. Randomization in a 1:1 ratio will be performed with computer-generated randomization list. All the included patients will be categorized into two groups: music therapy (MT) group and control group. Both groups will receive comprehensive in-patient education program for 12consecutive weeks, but the MT group will receive additional music therapy in the 12 consecutive weeks. The participants in MT group will receive neurologic music therapy 1 day per week for 1 hour with total 4 hours in 4 consecutive weeks after initial enrollment. The primary outcome is anxiety and fatigue. The Brief Fatigue Inventory-Taiwan (BFI-T) State anxiety inventory (STAI) and WHOQOL until 12 weeks after randomization. All health-related parameters will be evaluation prior to intervention and after intervention.
Aim of the study:
The aim of the study is to explore the impact of music therapy on anxiety and fatigue among patients with breast cancer. We aim to investigate whether music therapy is an optimal add-on therapeutic model for patients with breast cancer.
- Being tested
- music, comprehensive in-patient education program
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
Also called education
MT group receives additional music therapy
comprehensive in-patient education programOther
comprehensive in-patient education program
| Study group | Role | What they receive |
|---|---|---|
| MT group | Experimental | The participants in MT group will receive music therapy 1 day per week for 1 hour with total 12hours in12 consecutive weeks after initial enrollment. Initial evaluation at the first session, including patient's vital sign, consciousness and spirit. The music therapy will consist of therapeutic singing, interpersonal communication, melody intonation therapy and rhythmic hands slapping. During therapeutic singing session, the music therapists will sing a song first and then the patients sing it after them. Interpersonal communication activity will be led by the music therapist and passed on to one patient to another patient. Melody intonation therapy will comprise communication, chatting and read aloud by using melody. Receives: Other: music; Other: comprehensive in-patient education program |
| Control group | Placebo comparator | control groups will receive comprehensive in-patient education program for 12 consecutive weeks Receives: Other: comprehensive in-patient education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
State anxiety inventory (STAI) Survey
We accessed anxiety by State anxiety inventory (STAI) it has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level. Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval (Spielberger et al., 1983). Test-retest coefficients for this measure in the present study ranged from .69 to .89. Considerable evidence attests to the construct and concurrent validity of the scale (Spielberger, 1989).
Measured: 12 weeks
Secondary outcomes (1)
Brief Fatigue Inventory-Taiwan (BFI-T) Survey
The BFI-T scoring total ranges from0 to 90 points; a higher score corresponds to higher fatigue.
The BFI-T's internal consistency showed a Cronbach's ! value of .97. Construct validity of the BFI-T was estimated by factor analysis with a factor loading range of 0.80 to 0.94 on a single factor. Convergent validity was examined by correlations between the BFI ''worst'' fatigue and fatigue severity scores with Profile of Mood States vigor (r = j0.69 and j0.71, respectively) and fatigue subscale scores (r = 0.82 and 0.87, respectively)(Chou, Hsieh, Yao, \& Barsevick, 2016)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020
Why it stopped: miss contact
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music Therapy, Breast Cancer, Anxiety, FatigueStudies 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
- Single group
- Model description
- an assessor blinded, randomized, controlled, parallel group trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chinghui Chuang, PhD, Principal investigator, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540471
- Sponsor's protocol ID
- 201901698B0
- Status last verified
- Jan 2024
- First submitted
- 1 Sep 2020
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we decide to share on December 2020.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Nursing, Chang Gang Memorial Hospital
- ClinicalTrials.gov ID
- NCT04540471
- Acronym / sponsor ID
- 201901698B0
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: miss contact
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Sep 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.
Comprehensive inpatient rehabilitation for breast cancer consist of interdisciplinary team care but few researchers investigate the efficacy of music therapy, which have shown some benefits in breast cancer rehabilitation. According to previous research, music therapy has been proposed to improve quality of life, as well as depression and stress of breast cancer patients. However, to the best of our knowledge, only few studies have investigated the impact of music therapy among health-related parameter of patient with breast cancer. Considering the fact that music therapy had merely no adverse events, we assume music therapy is an optimal add-on therapy for patient with breast cancer. Therefore, we plan to conduct a study to evaluate the impact of music therapy on anxiety, and fatigue on patients with breast cancer.
Detailed description
Patients and Method:
We designed this study as an assessor blinded, randomized, controlled, parallel group trial. The participants will be recruited from general surgery unit of tertiary referral hospital in Southern Taiwan. Inclusion criteria will be as follows: (1) patients with first-ever breast cancer between 20~80 years old (1 to 6 months post- surgery) (2) able to follow basic orders (verbal or gesture) and tolerated music therapy by 1 hour. Individuals will be excluded from the study if they (1) are unable to cooperate with music therapy, (2) undergoing psychotherapeutic treatment during the study period, using antidepressants during the study period, (3) are significantly hearing impaired, not agree to sign the informed consent, or do not agree further evaluation, and (4) pregnant women. Randomization in a 1:1 ratio will be performed with computer-generated randomization list. All the included patients will be categorized into two groups: music therapy (MT) group and control group. Both groups will receive comprehensive in-patient education program for 12consecutive weeks, but the MT group will receive additional music therapy in the 12 consecutive weeks. The participants in MT group will receive neurologic music therapy 1 day per week for 1 hour with total 4 hours in 4 consecutive weeks after initial enrollment. The primary outcome is anxiety and fatigue. The Brief Fatigue Inventory-Taiwan (BFI-T) State anxiety inventory (STAI) and WHOQOL until 12 weeks after randomization. All health-related parameters will be evaluation prior to intervention and after intervention.
Aim of the study:
The aim of the study is to explore the impact of music therapy on anxiety and fatigue among patients with breast cancer. We aim to investigate whether music therapy is an optimal add-on therapeutic model for patients with breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- an assessor blinded, randomized, controlled, parallel group trial.
| Arm | Type | Receives |
|---|---|---|
| MT group | Experimental | Other: music, Other: comprehensive in-patient education programThe participants in MT group will receive music therapy 1 day per week for 1 hour with total 12hours in12 consecutive weeks after initial enrollment. Initial evaluation at the first session, including patient's vital sign, consciousness and spirit. The music therapy will consist of therapeutic singing, interpersonal communication, melody intonation therapy and rhythmic hands slapping. During therapeutic singing session, the music therapists will sing a song first and then the patients sing it after them. Interpersonal communication activity will be led by the music therapist and passed on to one patient to another patient. Melody intonation therapy will comprise communication, chatting and read aloud by using melody. |
| Control group | Placebo comparator | Other: comprehensive in-patient education programcontrol groups will receive comprehensive in-patient education program for 12 consecutive weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We design this study as an assessor blinded, randomized, controlled, parallel group trial. The participants will be recruited from OPD unit of tertiary referral hospital in Southern Taiwan. Inclusion criteria will be as follows: (1) patients with breast cancer between 20~80 years old at stage (1-6 months post surgery) (2) able to follow basic orders (verbal or gesture) and tolerated music therapy by 1 hour.
Key exclusion criteria (1 listed)
- Individuals will be excluded from the study if they are unable to cooperate with music therapy, are significantly hearing impaired, are severely mentally impaired (MMSE<10), or not agree to sign the informed consent, uncontrolled seizure or do not agree further evaluation. -
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 |
|---|---|---|
| musicAlso: educationMT group receives additional music therapy | Other | MT group |
| comprehensive in-patient education programcomprehensive in-patient education program | Other | Control group, MT group |
Primary outcome
State anxiety inventory (STAI) Survey
Time frame: 12 weeks
We accessed anxiety by State anxiety inventory (STAI) it has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level. Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval (Spielberger et al., 1983). Test-retest coefficients for this measure in the present study ranged from .69 to .89. Considerable evidence attests to the construct and concurrent validity of the scale (Spielberger, 1989).
1 secondary outcome
Brief Fatigue Inventory-Taiwan (BFI-T) Survey
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: Undecided. we decide to share on December 2020.
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.
Chinghui Chuang, PhD principal investigator
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music and comprehensive in-patient education program in people with Music Therapy, Breast Cancer, Anxiety, Fatigue, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 21 Aug 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
State anxiety inventory (STAI) Survey (time frame: 12 weeks). 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 21 Aug 2024.