Pain Management Support Study for Patients With Advanced Cancer

Not Applicable

Completed

• Conditions: Advanced Cancer
• Interventions: Behavioral: Interactive Music Therapy; Behavioral: Verbal support

• Registration Number: NCT03432247
• Lead Sponsor: Drexel University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-14
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-18
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interactive Music Therapy	Interactive Music Therapy	Six 45-minute individual interactive music therapy sessions.
Verbal-based support	Verbal support	Six 45-minute individual verbal support sessions

Primary Outcome Measures

Name	Time	Method
Pain Intensity	through study completion, a maximum of 12 weeks	measured by PROMIS® Pain Intensity-Short Form (SF)3a
Pain Interference	through study completion, a maximum of 12 weeks	measured by PROMIS® Cancer-Pain Interference -SF 6b
Patient Perception of Change	through study completion, a maximum of 12 weeks	measured by Patient Global Impression of Change Scale (PGIC)
Serum β-endorphin	through study completion, a maximum of 12 weeks	biomarker for pain intensity

Secondary Outcome Measures

Name	Time	Method
Anxiety	through study completion, a maximum of 12 weeks	Mediator outcome measured by PROMIS® Cancer-Anxiety - SF
Mood	through study completion, a maximum of 12 weeks	Mediator outcome measured by Positive and Negative Affect Scale (PANAS)
Lachrymal dopamine	through study completion, a maximum of 12 weeks	Mediator outcome (biomarker for mood)
Salivary cortisol	through study completion, a maximum of 12 weeks	Mediator outcome (biomarker for anxiety)
Serum oxytocin	through study completion, a maximum of 12 weeks	Mediator outcome (biomarker for social support)
Perceived support	through study completion, a maximum of 12 weeks	Mediator outcome measured by PROMIS® Emotional Support - SF 6a
Self-efficacy	through study completion, a maximum of 12 weeks	Mediator outcome measured by PROMIS® Self-Efficacy of Symptoms

Trial Locations

Locations (3)

Hahnemann University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Thomas Jefferson Sidney Kimmel Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Cancer Treatment Centers of America (CTCA); 🇺🇸 Philadelphia, Pennsylvania, United States