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Pain Management Support Study for Patients With Advanced Cancer

Trial Status: Active

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.

Inclusion Criteria

  • male or female outpatients with advanced cancer (Stage 3 & 4; or relapse refractory patients for myeloma)
  • diagnosed with locally advanced cancer that has extended to organs/soft tissue or is impinging on or eroding the bone; or bone metastases or soft tissue metastasis
  • moderate to severe pain with an average intensity ≥4 on a 0-10 Numeric Rating Scale (NRS)
  • experiencing pain for ≥ 3 months
  • Karnofsky Performance score of ≥ 60 or the Eastern Cooperative Group Performance Status (ECOG) equivalent of ≤ 2 (i.e. requires occasional assistance, but is able to care for most of their personal needs)

Exclusion Criteria

  • expected survival ≤ 3 months
  • primary central nervous system (CNS) tumor or CNS metastatic disease that impairs concentration, memory, balance or focus that would preclude ability to participate in a 60 minute, recurring activity and completion of self-report measures
  • hematologic malignancies except for myeloma which causes significant bone pain
  • ≤ 3 weeks post-operation from start of study
  • active psychosis or dementia
  • inability to speak or write English
  • moderate to severe hearing impairment
  • current smoking
  • current alcohol dependence

New Jersey

Sewell
Kennedy Health Systems-Cancer Center
Status: ACTIVE
Contact: Amy Leader

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Amy Leader
Phone: 215-955-7739

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.

Trial Phase Phase NA

Trial Type Supportive care

Lead Organization
Hahnemann University Hospital

  • Primary ID R01NR016681
  • Secondary IDs NCI-2018-00463, 1R01NR016681-01A1
  • Clinicaltrials.gov ID NCT03432247