Pain, ChronicNCT03782506
Pain Management Support Study for Cancer Survivors
A study testing Interactive Music Therapy and Verbal-based support in people with Pain, Chronic and Opioid Use, run by Drexel University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Opioid Use
- What is being tested?
- Interactive Music Therapy and Verbal-based support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
Thomas Jefferson Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Cancer Treatment Centers of America (CTCA)
Philadelphia, Pennsylvania, 19124
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Chronic, Opioid Use
- Being tested
- Interactive Music Therapy, Verbal-based support
- Keywords
- music therapy, pain management, opioid use, cancer survivors
- Medical subject headings
- Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Music TherapyBehavioural
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.
Verbal-based supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Music Therapy | Experimental | Ten 45-minute individual interactive music therapy sessions. Receives: Behavioral: Interactive Music Therapy |
| Verbal-based Support | Active comparator | Ten 45-minute individual verbal support sessions. Receives: Behavioral: Verbal-based support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily opioid dose
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.
Measured: Through study completion, a maximum of 28 weeks
Self-reported opioid use
Self-report on intake of opioids and NSAIDS through daily pain medication log
Measured: Through study completion, a maximum of 28 weeks
Secondary outcomes (8)
Pain intensity
Measured by PROMIS® Pain Intensity-Short Form (SF)3a
Measured: At baseline, post-intervention (week 10), and 3-month follow up
Pain interference
Measured by PROMIS® Cancer-Pain Interference -SF 6b
Measured: At baseline, post-intervention (week 10), and 3-month follow up
Self-efficacy
Measured by PROMIS® Self-Efficacy of Symptoms
Measured: At baseline, post-intervention (week 10), and 3-month follow up
Patient perception of change
Measured by Patient Global Impression of Change Scale (PGIC)
Measured: At post-intervention (week 10) and 3-month follow up
Physician perception of change
A brief questionnaire asking about their perception of how the participant is doing in terms of pain management
Measured: At baseline, post-intervention (week 10), and 3-month follow up
Anxiety
Measured by the PROMIS® Emotional Distress-Anxiety - SF6a
Measured: At baseline, post-intervention (week 10), and 3-month follow up
Depression
Measured by the PROMIS® Depression - SF 6a
Measured: At baseline, post-intervention (week 10), and 3-month follow up
Sleep quality
Measured by the PROMIS® Sleep Disturbance - SF4a
Measured: At baseline, post-intervention (week 10), and 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Nov 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joke Bradt, Drexel University
- Investigators
- Joke Bradt, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782506
- Sponsor's protocol ID
- 3R01NR016681-02S1
- Status last verified
- Feb 2022
- First submitted
- 17 Dec 2018
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Music Therapy on Opioid Use in Cancer Survivors With Chronic Pain
- ClinicalTrials.gov ID
- NCT03782506
- Acronym / sponsor ID
- 3R01NR016681-02S1
- Conditions
- Pain, Chronic, Opioid Use
- Keywords
- music therapy, pain management, opioid use, cancer survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Music Therapy | Experimental | Behavioral: Interactive Music TherapyTen 45-minute individual interactive music therapy sessions. |
| Verbal-based Support | Active comparator | Behavioral: Verbal-based supportTen 45-minute individual verbal support sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Music TherapyTen 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. | Behavioural | Interactive Music Therapy |
| Verbal-based supportTen 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. | Behavioural | Verbal-based Support |
Primary outcome
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.
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
8 secondary outcomes
Pain intensity
Time frame: 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
Self-efficacy
Time frame: 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
Physician perception of change
Time frame: 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
Depression
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joke Bradt, PhD principal investigator
Drexel University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Music Therapy and Verbal-based support in people with Pain, Chronic and Opioid Use, run by Drexel University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily opioid dose (time frame: Through study completion, a maximum of 28 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.