Pain Management Support Study for Cancer Survivors

Not Applicable

Completed

• Conditions: Pain, Chronic; Opioid Use
• Interventions: Behavioral: Interactive Music Therapy; Behavioral: Verbal-based support

• Registration Number: NCT03782506
• Lead Sponsor: Drexel University

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.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-20
• 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: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Daily opioid dose	Through study completion, a maximum of 28 weeks	Taking information from the Prescription Drug Monitoring Program, we will calculate the mean daily opioid dose for each participant by dividing the quantity of opioid pills prescribed by the number of days for which it was supplied.
Self-reported opioid use	Through study completion, a maximum of 28 weeks	Self-report on intake of opioids and NSAIDS through daily pain medication log

Secondary Outcome Measures

Name	Time	Method
Pain interference	At baseline, post-intervention (week 10), and 3-month follow up	Measured by PROMIS® Cancer-Pain Interference -SF 6b
Self-efficacy	At baseline, post-intervention (week 10), and 3-month follow up	Measured by PROMIS® Self-Efficacy of Symptoms
Pain intensity	At baseline, post-intervention (week 10), and 3-month follow up	Measured by PROMIS® Pain Intensity-Short Form (SF)3a
Patient perception of change	At post-intervention (week 10) and 3-month follow up	Measured by Patient Global Impression of Change Scale (PGIC)
Physician perception of change	At baseline, post-intervention (week 10), and 3-month follow up	A brief questionnaire asking about their perception of how the participant is doing in terms of pain management
Anxiety	At baseline, post-intervention (week 10), and 3-month follow up	Measured by the PROMIS® Emotional Distress-Anxiety - SF6a
Depression	At baseline, post-intervention (week 10), and 3-month follow up	Measured by the PROMIS® Depression - SF 6a
Sleep quality	At baseline, post-intervention (week 10), and 3-month follow up	Measured by the PROMIS® Sleep Disturbance - SF4a

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