- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03782506
Pain Management Support Study for Cancer Survivors
February 18, 2022 updated by: Joke Bradt, Drexel University
The Impact of Music Therapy on Opioid Use in Cancer Survivors With Chronic Pain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19102
- Hahnemann University Hospital
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson Sidney Kimmel Cancer Center
-
Philadelphia, Pennsylvania, United States, 19124
- Cancer Treatment Centers of America (CTCA)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interactive Music Therapy
Ten 45-minute individual interactive music therapy sessions.
|
Ten 45-minutes individual interactive music therapy (IMT) sessions delivered by a board-certified music therapist.
Sessions start with music-guided breathing or humming.
The music therapist then engages the participant in singing of familiar songs and co-created vocal or instrumental music improvisations.
Discussion about the meaning assigned to songs and emotions expressed through the improvisations follow.
Each session involves learning and practicing music-based techniques for the self-management of pain, anxiety, stress, mood, fatigue, and sleep disturbance as these are common opioid withdrawal symptoms.
Psychoeducation about opioid tapering is provided and tapering challenges experienced by the patient will be actively addressed through music-based interventions.
|
Active Comparator: Verbal-based Support
Ten 45-minute individual verbal support sessions.
|
Ten 45-minute individual sessions delivered by a master's level clinician with training in counseling.
The sessions are focused on patient-initiated conversations about their pain, life stressors and the impact on their daily life.
The intervener provides nondirective, supportive care by offering supportive, validating statements and reflective listening.
The intervener refrains from employing active suggestion, problem-solving or behavioral or cognitive therapy techniques.
The verbal support sessions are aimed at providing an empathic, therapeutic environment to facilitate emotional expression and sharing of worries and fears.
As in the IMT protocol, psychoeducation about opioid tapering will be included and will be considered the only active treatment factor for this intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily opioid dose
Time Frame: 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.
|
Through study completion, a maximum of 28 weeks
|
Self-reported opioid use
Time Frame: Through study completion, a maximum of 28 weeks
|
Self-report on intake of opioids and NSAIDS through daily pain medication log
|
Through study completion, a maximum of 28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: At baseline, post-intervention (week 10), and 3-month follow up
|
Measured by PROMIS® Pain Intensity-Short Form (SF)3a
|
At baseline, post-intervention (week 10), and 3-month follow up
|
Pain interference
Time Frame: At baseline, post-intervention (week 10), and 3-month follow up
|
Measured by PROMIS® Cancer-Pain Interference -SF 6b
|
At baseline, post-intervention (week 10), and 3-month follow up
|
Self-efficacy
Time Frame: At baseline, post-intervention (week 10), and 3-month follow up
|
Measured by PROMIS® Self-Efficacy of Symptoms
|
At baseline, post-intervention (week 10), and 3-month follow up
|
Patient perception of change
Time Frame: At post-intervention (week 10) and 3-month follow up
|
Measured by Patient Global Impression of Change Scale (PGIC)
|
At post-intervention (week 10) and 3-month follow up
|
Physician perception of change
Time Frame: 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
|
At baseline, post-intervention (week 10), and 3-month follow up
|
Anxiety
Time Frame: At baseline, post-intervention (week 10), and 3-month follow up
|
Measured by the PROMIS® Emotional Distress-Anxiety - SF6a
|
At baseline, post-intervention (week 10), and 3-month follow up
|
Depression
Time Frame: At baseline, post-intervention (week 10), and 3-month follow up
|
Measured by the PROMIS® Depression - SF 6a
|
At baseline, post-intervention (week 10), and 3-month follow up
|
Sleep quality
Time Frame: At baseline, post-intervention (week 10), and 3-month follow up
|
Measured by the PROMIS® Sleep Disturbance - SF4a
|
At baseline, post-intervention (week 10), and 3-month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2018
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
December 17, 2018
First Submitted That Met QC Criteria
December 18, 2018
First Posted (Actual)
December 20, 2018
Study Record Updates
Last Update Posted (Actual)
February 21, 2022
Last Update Submitted That Met QC Criteria
February 18, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3R01NR016681-02S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
We will make the de-identified datasets available to other researchers.
Researchers will be asked to submit a formal request for data sharing to the PI that outlines the purpose of the secondary data analysis.
Data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
IPD Sharing Time Frame
After completion of study report and publication of the results
IPD Sharing Access Criteria
We will make the de-identified datasets available to other researchers.
Researchers will be asked to submit a formal request for data sharing to the PI that outlines the purpose of the secondary data analysis.
Data and associated documentation will be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Opioid Use
-
Sharon WalshNational Institute on Drug Abuse (NIDA)Completed
-
Aurora Health CareUniversity of Chicago; University of California, Santa Cruz; Rogers Behavioral...RecruitingSubstance Use | Methamphetamine-dependence | Opioid Use | Opioid-use Disorder | Cocaine Use Disorder | Cocaine Use | Methamphetamine AbuseUnited States
-
Indonesia UniversityRecruiting
-
Lawson Health Research InstituteNot yet recruiting
-
University of Colorado, DenverUniversity of Nebraska; Agency for Healthcare Research and Quality (AHRQ)Completed
-
Zulekha HospitalsCompleted
-
Peking University People's HospitalCompleted
-
University of UtahCompleted
-
University Health Network, TorontoOntario Ministry of Health and Long Term CareCompleted
Clinical Trials on Interactive Music Therapy
-
Drexel UniversityNational Institute of Nursing Research (NINR)Completed
-
Yonsei UniversityCompletedCritically Ill Adult Patients in Intensive Care UnitsKorea, Republic of
-
Children's Hospital of Eastern OntarioCanadian Diabetes AssociationCompletedObesity | Overweight With ComorbidityCanada
-
Case Comprehensive Cancer CenterCompletedMultiple Myeloma | Hodgkin Lymphoma | Non-Hodgkin LymphomaUnited States
-
University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences InstituteCompletedAutonomic Nervous System Imbalance | Hypothalamic Pituitary Adrenal Axis SuppressionUnited States
-
Wayne State UniversityCompletedNeurological DisordersUnited States
-
Icahn School of Medicine at Mount SinaiCompletedSARS-CoV 2 | Dyspnea | Post Covid-19 RespiratoryUnited States
-
Icahn School of Medicine at Mount SinaiCompleted
-
Children's Healthcare of AtlantaCompletedRespiratory Syncytial Virus InfectionsUnited States
-
University of MilanUnknownCritical Illness | Music Therapy | Hypnotics and SedativesItaly