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Music as a Perioperative Therapy in Breast Cancer Patients

NCT ID: NCT03511079

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-10

Study Completion Date

2021-10-27

Brief Summary

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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

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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

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Breast Cancer

Keywords

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Music

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

There will be no blinding in this study.

Study Groups

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Music

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.

Group Type EXPERIMENTAL

Music

Intervention Type BEHAVIORAL

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.

Control

This group will not listen to music each night for the duration of the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Pandora Plus

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Prisoner
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kristine Widders

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristine L Widders, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Penn State Breast Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15576544 (View on PubMed)

Hole 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.

Reference Type BACKGROUND
PMID: 26277246 (View on PubMed)

Nilsson 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.

Reference Type BACKGROUND
PMID: 18395022 (View on PubMed)

Nilsson 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.

Reference Type BACKGROUND
PMID: 15816586 (View on PubMed)

Vetter 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.

Reference Type BACKGROUND
PMID: 26583656 (View on PubMed)

Orre 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.

Reference Type BACKGROUND
PMID: 21843747 (View on PubMed)

Bouchard 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.

Reference Type BACKGROUND
PMID: 26569533 (View on PubMed)

Akerstedt 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.

Reference Type BACKGROUND
PMID: 2265922 (View on PubMed)

Other Identifiers

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STUDY00007842

Identifier Type: -

Identifier Source: org_study_id