Music as a Perioperative Therapy in Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03511079|
Recruitment Status : Withdrawn (Difficulty with recruiting due to staffing and Covid-19)
First Posted : April 27, 2018
Last Update Posted : November 4, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Music||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Masking Description:||There will be no blinding in this study.|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of Perioperative Music on Quality of Life Measures and Biomarker Levels in Breast Cancer Patients|
|Actual Study Start Date :||July 10, 2019|
|Actual Primary Completion Date :||October 27, 2021|
|Actual Study Completion Date :||October 27, 2021|
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.
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.
Other Name: Pandora Plus
No Intervention: Control
This group will not listen to music each night for the duration of the study.
- 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:
- = 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.
- 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.
- 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). ]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).
- 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). ]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).
- 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). ]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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- 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)
- History of endocrine tumors
- Lack of electronic device (smartphone, computer, etc) on which to listen to music
- Cognitive impairment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511079
|United States, Pennsylvania|
|Penn State Breast Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Kristine L Widders, MD||Milton S. Hershey Medical Center|
|Responsible Party:||Kristine Widders, Assistant Professor of Surgery, Milton S. Hershey Medical Center|
|Other Study ID Numbers:||
|First Posted:||April 27, 2018 Key Record Dates|
|Last Update Posted:||November 4, 2021|
|Last Verified:||October 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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