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Pain Management Support Study for Cancer Survivors

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Drexel University

Status

Completed

Conditions

Pain, Chronic
Opioid Use

Treatments

Behavioral: Interactive Music Therapy
Behavioral: Verbal-based support

Study type

Interventional

Funder types

Other

Identifiers

NCT03782506
3R01NR016681-02S1

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 2 patient groups

Interactive Music Therapy
Experimental group
Description:
Ten 45-minute individual interactive music therapy sessions.
Treatment:
Behavioral: Interactive Music Therapy
Verbal-based Support
Active Comparator group
Description:
Ten 45-minute individual verbal support sessions.
Treatment:
Behavioral: Verbal-based support

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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