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Ten 45-minute individual interactive music therapy sessions.

Ten 45-minute individual verbal support sessions.

Ten 45-minutes individual interactive music therapy (IMT) sessions delivered by a board-certified music therapist. Sessions start with music-guided breathing or humming. The music therapist then engages the participant in singing of familiar songs and co-created vocal or instrumental music improvisations. Discussion about the meaning assigned to songs and emotions expressed through the improvisations follow. Each session involves learning and practicing music-based techniques for the self-management of pain, anxiety, stress, mood, fatigue, and sleep disturbance as these are common opioid withdrawal symptoms. Psychoeducation about opioid tapering is provided and tapering challenges experienced by the patient will be actively addressed through music-based interventions.

Interactive Music Therapy

Ten 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. As in the IMT protocol, psychoeducation about opioid tapering will be included and will be considered the only active treatment factor for this intervention.

Verbal-based support

Joke Bradt, PhD

Pain in cancer survivors is difficult to treat, and unrelieved pain can greatly reduce a person's quality of life. Opioids are often prescribed for pain management, yet they can have undesirable side effects and may put someone at risk for addiction or dependence. The purpose of this study is to examine the impact of an interactive music therapy intervention on pain management and opioid use in cancer survivors.

As many as 40% of cancer survivors report experiencing chronic pain, and recent research indicates that pain is not well managed. Opioids are often prescribed during active cancer treatment for pain management, and many cancer survivors continue the same pain management regimen long after completing their cancer treatment. Reports indicate that prescription rates are up to 1.22 times higher for cancer cancer survivors than people without a cancer diagnosis, and the American Society of Clinical Oncology recommends that opioid tapering should be a priority once someone moves into survivorship status. Music interventions have been used for pain management in people with cancer, yet few studies have examined music therapy for chronic pain in cancer survivors. Moreover, none of these studies have not examined opioid use as a measure. Therefore, the overarching goals of this pilot study are to investigate the impact of an interactive music therapy (IMT) intervention on pain management and opioid use in cancer survivors with chronic pain versus a verbal-based support program (social attention control). This pilot 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. We will randomize 40 cancer survivors to one of two 10-session treatments: 1) Interactive Music Therapy or 2) Social Attention Control. Primary (mean daily opioid use) and secondary outcomes (pain intensity, pain interference, pain-related self-efficacy, patient perception of change, and physician perception of change in pain management) will be measured at baseline, post-intervention and 3-month follow-up. Follow-up interviews with a subsample of 12 participants and 4 physicians will enable us to gain a better understanding of potential treatment benefits, learn about challenges encountered, and obtain suggestions for treatment optimization. This is the first music therapy study to examine the benefits of music therapy for opioid tapering in cancer survivors with chronic pain and the results will be used to establish estimates of variance for sample size calculations for a larger-scale randomized control trial.

Pain Management Support Study for Cancer Survivors

The Impact of Music Therapy on Opioid Use in Cancer Survivors With Chronic Pain

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.

Taking information from the Prescription Drug Monitoring Program, we will calculate the mean daily opioid dose for each participant by dividing the quantity of opioid pills prescribed by the number of days for which it was supplied.

Self-report on intake of opioids and NSAIDS through daily pain medication log

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

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

Measured by PROMIS® Self-Efficacy of Symptoms

Measured by Patient Global Impression of Change Scale (PGIC)

A brief questionnaire asking about their perception of how the participant is doing in terms of pain management

Measured by the PROMIS® Emotional Distress-Anxiety - SF6a

Measured by the PROMIS® Depression - SF 6a

Measured by the PROMIS® Sleep Disturbance - SF4a

Drexel University

Professor

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.

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

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

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
Pain Management Support Study for Cancer Survivors	NCT03782506	Pain, Chronic Opioid Use	Interactive Mus... Verbal-based su...	18 Years -	Drexel University
Pain Management Support Study for Cancer Survivors	NCT03782506	Pain, Chronic Opioid Use	Interactive Mus... Verbal-based su...	18 Years -	Drexel University
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 interactive music therapy