Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Carcinoma In Situ

Carcinoma

Carcinoma in Situ

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete.

Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia.

Hypnosedation

Questionnaire Administration

Verbal Support

Lorenzo Cohen

This clinical trial studies how well hypnosedation works in relaxing and reducing the need for general anesthesia in patients who are undergoing breast cancer surgery. Hypnosedation is a technique that places patients under conscious sedation where they remain awake and numbed during surgery and involves the use of words and images to help patients relax and to affect their thoughts about what is happening during surgery.

PRIMARY OBJECTIVES:

I. Determine the feasibility of conducting a randomized controlled trial (RCT) of hypnosedation (HS) during breast cancer surgery.

SECONDARY OBJECTIVES:

I. Assess the preliminary efficacy of HS with local anesthesia versus (vs) opioid based general anesthesia (GA) on reducing self-reported anxiety, pain, nausea, vomiting, cancer-related symptoms, and surgical complication rates.

II. Preliminarily evaluate changes in immune markers (natural killer cell function, cytokines, and resolution of inflammatory response markers) and endocrine function (epinephrine, norepinephrine, and cortisol).

III. Preliminarily identify changes in neurological activity as assessed through electroencephalogram (EEG) activity.

IV. Preliminarily evaluate the group differences in medical costs.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete.

GROUP II: Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia.

After completion of study intervention, patients are followed up at days 1, 3, 5, 7, and 14.

Hypnosedation in Relaxing Patients Undergoing Breast Cancer Surgery

Biobehavioral Effects of Hypnosis During Breast Cancer Surgery

Will be determined by two criteria: overall accrual and successful delivery of HS. The intervention will be deemed feasible if: 1) \>= 30% of enrolled patients consent and \>= 60% of enrolled patients in HS complete surgery without the need of general anesthesia. The study will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.

Will estimate the mean differences of these outcomes between groups and corresponding 90% confidence intervals at specified points in time (baseline, during the procedure, if applicable, and post-procedure), as well as across time points, using linear mixed models (LMMs). Will similarly evaluate the difference in the slope of change for these outcomes between arms. Baseline covariates such as those used in the minimization will be controlled for in our analyses. Time-varying predictors (such as electroencephalograms \[EEGs\]) may be controlled for in additional exploratory analyses. Standard model diagnostics will be applied to check for model assumptions, such as normality of the residual distribution.

One test for each of the nine frequency band pass regions will be conducted as well as voxel-by-voxel t-tests computed for the whole data set. For each subject, power means within the frequency bands will be summed across all electrode sites in both absolute and relative power. Within-group differences will be examined using paired-sample t-tests. Between-group differences will be examined using analysis of covariance (ANCOVA) with the condition as the fixed variable, baseline EEG scores as the covariate, and post intervention scores as the dependent variable. Percent signal changes will be computed at all six time points of interest in our predetermined regions of interest (ROIs).

Will obtain detailed billing records from the date of surgery to the point of discharge at 14 days (+/- 5 days) and quantify medical costs in two ways. The first method is to apply cost-to-charge ratio to convert charges on the billing records to cost. The second method will identify from the study's institutional database each billing code appearing in patient's professional and technical charges, and calculate costs using Medicare reimbursement rates corresponding to current procedural terminology (CPT) codes. Because medical costs are highly skewed, the study will apply the non-parametric bootstrapping method to compare difference in medical costs between groups.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Symptoms and General Pathology

Pain

Six 45-minute individual interactive music therapy sessions.

Six 45-minute individual verbal support sessions

Six 45-minute individual interactive music therapy (IMT) sessions delivered by a board-certified music therapist. Sessions start with music-guided breathing, imagery, or humming. The music therapist then engages the participant in singing of familiar songs and co-created vocal or instrumental music improvisations based on patient needs. Discussion about the meaning assigned to songs and emotions expressed through the improvisations follow. The IMT experiences are aimed at facilitating emotional expression, offering support through interactive music making, and strengthening inner resources of creativity. In addition, each week the participant learns music-based techniques for self-management of anxiety, stress, mood, and pain.

Interactive Music Therapy

Six 45-minute individual sessions delivered by a master's level clinician with training in counseling. The sessions are focused on patient-initiated conversations about their pain, life stressors and the impact on their daily life. The intervener provides nondirective, supportive care by offering supportive, validating statements and reflective listening. The intervener refrains from employing active suggestion, problem-solving or behavioral or cognitive therapy techniques. The verbal support sessions are aimed at providing an empathic, therapeutic environment to facilitate emotional expression and sharing of worries and fears.

Verbal support

Joke Bradt, PhD

Chronic pain is one of the most feared symptoms in people with cancer. Insufficient relief from pharmacological treatments and the fear of side effects are important reasons for the growing use of complementary pain management approaches in cancer care. On such approach is music therapy. Although several studies have demonstrated that music therapy interventions can reduce pain in people with cancer, few studies have examined the therapeutic mechanisms that explain how music therapy interventions lead to improved pain management. The purpose of this study is to examine whether an interactive music therapy intervention improves psychological and social factors that play an important role in chronic pain management in people with advanced cancer. The findings will contribute towards the optimization of music therapy for palliation of chronic pain in people with advanced cancer.

This study addresses the public health problem of chronic pain as one of the most feared symptoms in people with cancer, with 70% to 90% of patients with advanced disease reporting pain. Unrelieved pain remains a challenge in cancer care. Insufficient relief from pharmacological treatments and the fear of side effects are important reasons for the growing use of complementary pain management approaches in people with cancer. One such approach is music therapy. Although efficacy of music therapy for pain has been established, there are no mechanistic studies clarifying how it works in clinical populations. Thus, there is a lack of knowledge related to 1) therapeutic mechanisms that lead to improvement (mediator effects) and 2) the relationship between patient characteristics and treatment response (moderator effects). Yet, it is well accepted that knowledge of mediators and moderators as well as a validated theory of action (i.e., how the intervention activates the mediators) are needed to optimize psychosocial treatment interventions. Therefore, the overarching goals of this study are to 1) examine mediators and moderators hypothesized to account for the pain-reducing effects of Interactive Music Therapy (IMT) in people with advanced cancer and chronic pain and 2) validate IMT's theory of action. The mediation model to be tested in this study aligns with a biopsychosocial framework to palliation of chronic pain and is based on findings from a preliminary study. The investigators postulate that anxiety, mood, self-efficacy and perceived support mediate the effects of IMT on pain outcomes (i.e. pain intensity and pain interference). In addition, the impact of several moderators on the hypothesized mediation model, namely adult playfulness, perceived musical competence, and treatment expectancy, will be tested. This study uses a mixed methods intervention design in which qualitative data (i.e. semi-structured follow-up interviews) are embedded within a randomized controlled trial. A total of 100 outpatients with advanced cancer and chronic bone pain will be randomized to one of two 6-week treatments: 1) Interactive Music Therapy or 2) Verbal-based support. The mediators and pain outcomes will be measured at baseline and after the fourth and sixth session using self-report measures as well as biomarkers (salivary cortisol, lachrymal dopamine content, serum oxytocin, and plasma β-endorphins). Follow-up interviews with a subsample of 30 participants will enable the investigators to examine the congruence between the hypothesized mediators and moderators and participant explanations of how IMT influences chronic pain management (i.e. theory of action). This study will contribute towards the optimization of music therapy for palliation of chronic pain in people with advanced cancer through a better understanding of the impact of mediators and moderators of IMT on chronic pain management. The results of this study will provide estimated effects sizes of IMT on the mediators and preliminary effect size estimates for the pain outcomes. This information will be instrumental in the development of a subsequent large-scale efficacy trial.

Pain Management Support Study for Patients With Advanced Cancer

Mechanisms of Music Therapy to Palliate Pain in Patients With Advanced Cancer

We will make the de-identified datasets available to other researchers. Researchers will be asked to submit a formal request for data sharing to the PI that outlines the purpose of the secondary data analysis. Data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Moderator outcome measured by Credibility/Expectancy Questionnaire (CEQ)

Moderator outcome measured by two-item questionnaire

Moderator outcome measured by Short Measure for Adult Playfulness (SMAP)

measured by PROMIS® Pain Intensity-Short Form (SF)3a

measured by PROMIS® Cancer-Pain Interference -SF 6b

measured by Patient Global Impression of Change Scale (PGIC)

Mediator outcome measured by PROMIS® Cancer-Anxiety - SF

Mediator outcome measured by Positive and Negative Affect Scale (PANAS)

Mediator outcome measured by PROMIS® Emotional Support - SF 6a

Mediator outcome measured by PROMIS® Self-Efficacy of Symptoms

Mediator outcome (biomarker for social support)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hypnosedation in Relaxing Patients Undergoing Breast Cancer Surgery	NCT03012399	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag...	Hypnosedation Questionnaire A... Verbal Support	18 Years -	M.D. Anderson Cancer Center
Pain Management Support Study for Patients With Advanced Cancer	NCT03432247	Advanced Cancer	Interactive Mus... Verbal support	18 Years -	Drexel University

Spots Global Cancer Trial Database for verbal support