Breast CancerNCT03511079
Music as a Perioperative Therapy in Breast Cancer Patients
A study testing Music in people with Breast Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Music has often been used in hospitals as a therapy but there is a limited amount of research looking at how music actually affects the different molecules in the body, such as cortisol (a marker of stress). There is especially a lack of research in the context of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2019to 27 Oct 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stage 0 to stage III breast cancer as classified by the American Joint Committee on Cancer
- Undergoing a mastectomy or lumpectomy at Penn State Hershey Medical Center
- Fluent in written and spoken English
Who cannot join
- Hearing loss or other difficulties hearing that, in the opinion of the research team, prevent the subject from listening to music
- Serious oral health or dental conditions that affect saliva production
- Patients who have undergone pre-operative chemotherapy or pre-operative radiation therapy
- Should not be taking supplements of melatonin or taking corticosteroids
- History of liver cancer
- History of liver disease or cirrhosis (based on MELD score)
Show all 10Show fewer
- History of endocrine tumors
- Lack of electronic device (smartphone, computer, etc) on which to listen to music
- Cognitive impairment
- Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Breast Center
Hershey, Pennsylvania, 17033
About this study
Official title: Impact of Perioperative Music on Quality of Life Measures and Biomarker Levels in Breast Cancer Patients
Music has often been used in hospitals as a therapy but there is a limited amount of research looking at how music actually affects the different molecules in the body, such as cortisol (a marker of stress). There is especially a lack of research in the context of surgery. The hope is that this study will show that music can be used to minimize some of the side effects related to breast surgery and improve the patient experience.
Read the detailed description
In medical practice, an ideal therapy should have maximal benefit with minimal risk. While considerable effort is being placed into discovering more effective pharmaceuticals, there is a growing field of interest in alternative therapies. In the 1970's, George Engle put forward the idea of the biopsychosocial response in which the patient's social and psychological factors can influence the body's biologic function and vice versa. One such potential therapy that could work by this mechanism is music. Advantages of music include low cost, availability, no required expertise, and minimal side effects. Studies have shown that music leads to reduced postoperative pain, anxiety, and analgesic needs in surgical patients. It has also been shown that patient selected music has greater outcomes than researcher selected music. While there is a significant body of literature on changes in clinical measurements, there are only two studies known to us which try to examine the effects of music on a molecular level, measuring cortisol and blood glucose respectively. Neither of these studies have been performed in patients undergoing surgery for breast cancer.
On the other hand, considerable research is currently being conducted to determine biomarkers in the context of surgery that are associated with poor outcomes, especially in the context of breast surgery. Stress, usually associated with cortisol levels, has been associated with increased sleep disruption, increased metabolism, increased risk of thromboembolic events, and impaired wound healing in patients. In breast cancer patients, it has been found that C-reactive protein levels correlated in fatigue postoperatively and decreased diurnal variation in cortisol has been associated with depression. Melatonin, in general, is a marker for circadian rhythm and would also be representative of sleep disruption. C-reactive protein is primarily a marker of inflammation which in turn is associated with disease progression and poorer clinical outcomes in breast surgery patients.
This study aims to determine both if music affects molecular mechanisms through measurement of clinical biomarkers as well as if there is an association with significant quality of life measures. A positive association could provide evidence into music being used as an adjunct therapy peri-operatively.
- Conditions
- Breast Cancer
- Being tested
- Music
- Keywords
- Music
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Also called Pandora Plus
Music will be delivered through Pandora Plus radio via patient's computer or smartphone. The patient will choose a favorite song to create a playlist which will be used for the duration of the entire study. The subgenre of the initial song will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | This group will be given a subscription to Pandora Plus for the duration of the study. Beginning two nights before surgery, they will listen to a music playlist they created for 30 minutes prior to going to sleep. This will continue each night with the final time being 6 nights after surgery. Receives: Behavioral: Music |
| Control | No intervention | This group will not listen to music each night for the duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Pain will be measured using select questions from the BREAST-Q model. The individual pain items will be measured on a 5 point Likert scale as follows:
- = None of the time
- = A little of the time
- = Some of the time
- = Most of the time
- = All of the time
Total summed scores range from 12 to 60 in breast conserving modules and 16 to 80 for mastectomy modules. Higher scores are representative of more pain experienced by the patient.
Measured: The survey will be given three days prior to surgery and seven days after surgery.
Change in Sleep Quality
Sleep quality will be measured by the Karolinska Sleepiness scale. The KSS is a 9-point Likert scale often used when conducting studies involving self-reported, subjective assessment of an individual's level of drowsiness at the time. The KSS Scores are defined as follows:
- Extremely sleepy, fighting sleep 8. Sleepy, some effort to keep alert 7. Sleepy, but no difficulty remaining awake 6. Some signs of sleepiness 5. Neither alert nor sleepy 4. Rather alert 3. Alert 2. Very alert
- Extremely alert
Higher values indicate a higher level of drowsiness.
Measured: The scale will given three days prior to surgery and seven days after surgery.
Change in Depression
Depression will be measured with the Center for Epidemiologic Studies-Depression scale. The CES-D scale is a 20-item measure that measures how often over the past week one has experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely.
Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Total summed scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Measured: The questionnaire will be given three days prior to surgery and seven days after surgery.
Secondary outcomes (3)
Change in Salivary Cortisol level
Samples will be taken 30 minutes after awakening (AM) and 30 minutes prior to falling asleep (PM) on select days (except the evening of the day of surgery).
Measured: Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).
Change in Salivary Melatonin level
Samples will be taken 30 minutes after awakening (AM) and 30 minutes prior to falling asleep (PM) on select days (except the evening of the day of surgery).
Measured: Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).
Change in Salivary C-reactive protein level
Samples will be taken 30 minutes after awakening (AM) and 30 minutes prior to falling asleep (PM) on select days (except the evening of the day of surgery).
Measured: Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start10 Jul 2019
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Why it stopped: Difficulty with recruiting due to staffing and Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- There will be two groups. The intervention group will listen to music each night several days before and after surgery. The control group will not listen to music each night around the time of surgery.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristine Widders, Milton S. Hershey Medical Center
- Investigators
- Kristine L Widders, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511079
- Sponsor's protocol ID
- STUDY00007842
- Status last verified
- Oct 2021
- First submitted
- 14 Mar 2018
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borrell-Carrio F, Suchman AL, Epstein RM. The biopsychosocial model 25 years later: principles, practice, and scientific inquiry. Ann Fam Med. 2004 Nov-Dec;2(6):576-82. doi: 10.1370/afm.245.
PubMed 15576544Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
PubMed 26277246Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013.
PubMed 18395022Nilsson U, Unosson M, Rawal N. Stress reduction and analgesia in patients exposed to calming music postoperatively: a randomized controlled trial. Eur J Anaesthesiol. 2005 Feb;22(2):96-102. doi: 10.1017/s0265021505000189.
PubMed 15816586Vetter D, Barth J, Uyulmaz S, Uyulmaz S, Vonlanthen R, Belli G, Montorsi M, Bismuth H, Witt CM, Clavien PA. Effects of Art on Surgical Patients: A Systematic Review and Meta-analysis. Ann Surg. 2015 Nov;262(5):704-13. doi: 10.1097/SLA.0000000000001480.
PubMed 26583656Orre IJ, Reinertsen KV, Aukrust P, Dahl AA, Fossa SD, Ueland T, Murison R. Higher levels of fatigue are associated with higher CRP levels in disease-free breast cancer survivors. J Psychosom Res. 2011 Sep;71(3):136-41. doi: 10.1016/j.jpsychores.2011.04.003. Epub 2011 May 18.
PubMed 21843747Bouchard LC, Antoni MH, Blomberg BB, Stagl JM, Gudenkauf LM, Jutagir DR, Diaz A, Lechner S, Gluck S, Derhagopian RP, Carver CS. Postsurgical Depressive Symptoms and Proinflammatory Cytokine Elevations in Women Undergoing Primary Treatment for Breast Cancer. Psychosom Med. 2016 Jan;78(1):26-37. doi: 10.1097/PSY.0000000000000261.
PubMed 26569533Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.
PubMed 2265922
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Music on Quality of Life Measures and Biomarker Levels in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03511079
- Acronym / sponsor ID
- STUDY00007842
- Conditions
- Breast Cancer
- Keywords
- Music
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty with recruiting due to staffing and Covid-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 27 Apr 2018 (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.
Music has often been used in hospitals as a therapy but there is a limited amount of research looking at how music actually affects the different molecules in the body, such as cortisol (a marker of stress). There is especially a lack of research in the context of surgery. The hope is that this study will show that music can be used to minimize some of the side effects related to breast surgery and improve the patient experience.
Detailed description
In medical practice, an ideal therapy should have maximal benefit with minimal risk. While considerable effort is being placed into discovering more effective pharmaceuticals, there is a growing field of interest in alternative therapies. In the 1970's, George Engle put forward the idea of the biopsychosocial response in which the patient's social and psychological factors can influence the body's biologic function and vice versa. One such potential therapy that could work by this mechanism is music. Advantages of music include low cost, availability, no required expertise, and minimal side effects. Studies have shown that music leads to reduced postoperative pain, anxiety, and analgesic needs in surgical patients. It has also been shown that patient selected music has greater outcomes than researcher selected music. While there is a significant body of literature on changes in clinical measurements, there are only two studies known to us which try to examine the effects of music on a molecular level, measuring cortisol and blood glucose respectively. Neither of these studies have been performed in patients undergoing surgery for breast cancer.
On the other hand, considerable research is currently being conducted to determine biomarkers in the context of surgery that are associated with poor outcomes, especially in the context of breast surgery. Stress, usually associated with cortisol levels, has been associated with increased sleep disruption, increased metabolism, increased risk of thromboembolic events, and impaired wound healing in patients. In breast cancer patients, it has been found that C-reactive protein levels correlated in fatigue postoperatively and decreased diurnal variation in cortisol has been associated with depression. Melatonin, in general, is a marker for circadian rhythm and would also be representative of sleep disruption. C-reactive protein is primarily a marker of inflammation which in turn is associated with disease progression and poorer clinical outcomes in breast surgery patients.
This study aims to determine both if music affects molecular mechanisms through measurement of clinical biomarkers as well as if there is an association with significant quality of life measures. A positive association could provide evidence into music being used as an adjunct therapy peri-operatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two groups. The intervention group will listen to music each night several days before and after surgery. The control group will not listen to music each night around the time of surgery.
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Behavioral: MusicThis group will be given a subscription to Pandora Plus for the duration of the study. Beginning two nights before surgery, they will listen to a music playlist they created for 30 minutes prior to going to sleep. This will continue each night with the final time being 6 nights after surgery. |
| Control | No intervention | –This group will not listen to music each night for the duration of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of stage 0 to stage III breast cancer as classified by the American Joint Committee on Cancer
- Undergoing a mastectomy or lumpectomy at Penn State Hershey Medical Center
- Fluent in written and spoken English
Key exclusion criteria (10 listed)
- Hearing loss or other difficulties hearing that, in the opinion of the research team, prevent the subject from listening to music
- Serious oral health or dental conditions that affect saliva production
- Patients who have undergone pre-operative chemotherapy or pre-operative radiation therapy
- Should not be taking supplements of melatonin or taking corticosteroids
- History of liver cancer
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: Pandora PlusMusic will be delivered through Pandora Plus radio via patient's computer or smartphone. The patient will choose a favorite song to create a playlist which will be used for the duration of the entire study. The subgenre of the initial song will be recorded. | Behavioural | Music |
Primary outcome
Change in Pain
Time frame: The survey will be given three days prior to surgery and seven days after surgery.
Pain will be measured using select questions from the BREAST-Q model. The individual pain items will be measured on a 5 point Likert scale as follows: 1. = None of the time 2. = A little of the time 3. = Some of the time 4. = Most of the time 5. = All of the time Total summed scores range from 12 to 60 in breast conserving modules and 16 to 80 for mastectomy modules. Higher scores are representative of more pain experienced by the patient.
Change in Sleep Quality
Time frame: The scale will given three days prior to surgery and seven days after surgery.
Sleep quality will be measured by the Karolinska Sleepiness scale. The KSS is a 9-point Likert scale often used when conducting studies involving self-reported, subjective assessment of an individual's level of drowsiness at the time. The KSS Scores are defined as follows: 9. Extremely sleepy, fighting sleep 8. Sleepy, some effort to keep alert 7. Sleepy, but no difficulty remaining awake 6. Some signs of sleepiness 5. Neither alert nor sleepy 4. Rather alert 3. Alert 2. Very alert 1. Extremely alert Higher values indicate a higher level of drowsiness.
Change in Depression
Time frame: The questionnaire will be given three days prior to surgery and seven days after surgery.
Depression will be measured with the Center for Epidemiologic Studies-Depression scale. The CES-D scale is a 20-item measure that measures how often over the past week one has experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Total summed scores range from 0 to 60, with high scores indicating greater depressive symptoms.
3 secondary outcomes
Change in Salivary Cortisol level
Time frame: Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).
Change in Salivary Melatonin level
Time frame: Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).
Change in Salivary C-reactive protein level
Time frame: Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).
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 4 Nov 2021.
- Background: PubMed 15576544Borrell-Carrio F, Suchman AL, Epstein RM. The biopsychosocial model 25 years later: principles, practice, and scientific inquiry. Ann Fam Med. 2004 Nov-Dec;2(6):576-82. doi: 10.1370/afm.245.
- Background: PubMed 26277246Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
- Background: PubMed 18395022Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013.
- Background: PubMed 15816586Nilsson U, Unosson M, Rawal N. Stress reduction and analgesia in patients exposed to calming music postoperatively: a randomized controlled trial. Eur J Anaesthesiol. 2005 Feb;22(2):96-102. doi: 10.1017/s0265021505000189.
- Background: PubMed 26583656Vetter D, Barth J, Uyulmaz S, Uyulmaz S, Vonlanthen R, Belli G, Montorsi M, Bismuth H, Witt CM, Clavien PA. Effects of Art on Surgical Patients: A Systematic Review and Meta-analysis. Ann Surg. 2015 Nov;262(5):704-13. doi: 10.1097/SLA.0000000000001480.
- Background: PubMed 21843747Orre IJ, Reinertsen KV, Aukrust P, Dahl AA, Fossa SD, Ueland T, Murison R. Higher levels of fatigue are associated with higher CRP levels in disease-free breast cancer survivors. J Psychosom Res. 2011 Sep;71(3):136-41. doi: 10.1016/j.jpsychores.2011.04.003. Epub 2011 May 18.
- Background: PubMed 26569533Bouchard LC, Antoni MH, Blomberg BB, Stagl JM, Gudenkauf LM, Jutagir DR, Diaz A, Lechner S, Gluck S, Derhagopian RP, Carver CS. Postsurgical Depressive Symptoms and Proinflammatory Cytokine Elevations in Women Undergoing Primary Treatment for Breast Cancer. Psychosom Med. 2016 Jan;78(1):26-37. doi: 10.1097/PSY.0000000000000261.
- Background: PubMed 2265922Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.
- 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.
Kristine L Widders, MD principal investigator
Milton S. Hershey Medical Center
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 in people with Breast Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
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 3 inclusion and 10 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 4 Nov 2021. 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 United States. 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 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?
Change in Pain (time frame: The survey will be given three days prior to surgery and seven days after surgery.). 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?
On the ClinicalTrials.gov record for NCT03511079, which also lists 8 linked publications.
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 4 Nov 2021.