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.
