Pain Management Support Study for Patients With Advanced Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/20/2018 |
| Start Date: | February 1, 2018 |
| End Date: | June 30, 2020 |
| Contact: | Joke Bradt, PhD |
| Email: | pmss@drexel.edu |
| Phone: | 267-359 5508 |
Mechanisms of Music Therapy to Palliate Pain in Patients With Advanced Cancer
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.
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.
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.
Inclusion Criteria:
- male or female outpatients with advanced cancer (Stage 3 & 4)
- diagnosed with radiologically evident bone metastases or locally advanced cancer
impinging on/eroding the bone
- moderate to severe bone 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
We found this trial at
2
sites
Philadelphia, Pennsylvania 19102
Principal Investigator: Cynthia Gifford-Hollingsworth, DrNP
Phone: 215-762-2619
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233 South 10th Street
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Principal Investigator: Amy Leader, DrPH
Phone: 267-760-4562
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