Clinical trial NCT03782506: Pain Management Support Study for Cancer Survivors
Official title: The Impact of Music Therapy on Opioid Use in Cancer Survivors With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Opioid Use
Keywords: music therapy
pain management
opioid use
cancer survivors
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* adult cancer survivors
* chronic pain for ≥ 3 months
* chronic opioid use (i.e., use of opioids for more than 90 days)
* willingness to reduce the amount of opioids currently taking

Exclusion Criteria:

* history of polysubstance abuse/substance use disorder
* currently receiving methadone maintenance or suboxone treatment
* active psychosis or dementia
* inability to speak or write English
* moderate to severe hearing impairment

Primary outcomes:
measure: Daily opioid dose
timeFrame: Through study completion, a maximum of 28 weeks
measure: Self-reported opioid use
timeFrame: Through study completion, a maximum of 28 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: At baseline, post-intervention (week 10), and 3-month follow up
measure: Pain interference
timeFrame: At baseline, post-intervention (week 10), and 3-month follow up
measure: Self-efficacy
timeFrame: At baseline, post-intervention (week 10), and 3-month follow up
measure: Patient perception of change
timeFrame: At post-intervention (week 10) and 3-month follow up
measure: Physician perception of change
timeFrame: At baseline, post-intervention (week 10), and 3-month follow up
measure: Anxiety
timeFrame: At baseline, post-intervention (week 10), and 3-month follow up
measure: Depression
timeFrame: At baseline, post-intervention (week 10), and 3-month follow up
measure: Sleep quality
timeFrame: At baseline, post-intervention (week 10), and 3-month follow up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson Sidney Kimmel Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cancer Treatment Centers of America (CTCA)
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Joke Bradt, PhD
role: PRINCIPAL_INVESTIGATOR
References: