Advanced CancerNCT03432247
Pain Management Support Study for Patients With Advanced Cancer
A study testing Interactive Music Therapy and Verbal support in people with Advanced Cancer, run by Drexel University at 3 sites in United States.
Trial summary
Chronic pain is one of the most feared symptoms in people with cancer. Insufficient relief from pharmacological treatments and the fear of side effects are important reasons for the growing use of complementary pain management approaches in cancer care. On such approach is music therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Interactive Music Therapy and Verbal support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 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
- male or female outpatients with advanced cancer (Stage 3 \& 4; or relapse refractory patients for myeloma)
- diagnosed with locally advanced cancer that has extended to organs/soft tissue or is impinging on or eroding the bone; or bone metastases or soft tissue metastasis
- moderate to severe pain with an average intensity ≥4 on a 0-10 Numeric Rating Scale (NRS)
- experiencing pain for ≥ 3 months
- Karnofsky Performance score of ≥ 60 or the Eastern Cooperative Group Performance Status (ECOG) equivalent of ≤ 2 (i.e. requires occasional assistance, but is able to care for most of their personal needs)
Who cannot join
- expected survival ≤ 3 months
- primary central nervous system (CNS) tumor or CNS metastatic disease that impairs concentration, memory, balance or focus that would preclude ability to participate in a 60 minute, recurring activity and completion of self-report measures
- hematologic malignancies except for myeloma which causes significant bone pain
- ≤ 3 weeks post-operation from start of study
- active psychosis or dementia
- inability to speak or write English
Show all 9Show fewer
- moderate to severe hearing impairment
- current smoking
- current alcohol dependence
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: Mechanisms of Music Therapy to Palliate Pain in Patients With Advanced Cancer
Chronic pain is one of the most feared symptoms in people with cancer. Insufficient relief from pharmacological treatments and the fear of side effects are important reasons for the growing use of complementary pain management approaches in cancer care. On such approach is music therapy. Although several studies have demonstrated that music therapy interventions can reduce pain in people with cancer, few studies have examined the therapeutic mechanisms that explain how music therapy interventions lead to improved pain management. The purpose of this study is to examine whether an interactive music therapy intervention improves psychological and social factors that play an important role in chronic pain management in people with advanced cancer. The findings will contribute towards the optimization of music therapy for palliation of chronic pain in people with advanced cancer.
Read the detailed description
This study addresses the public health problem of chronic pain as one of the most feared symptoms in people with cancer, with 70% to 90% of patients with advanced disease reporting pain. Unrelieved pain remains a challenge in cancer care. Insufficient relief from pharmacological treatments and the fear of side effects are important reasons for the growing use of complementary pain management approaches in people with cancer. One such approach is music therapy. Although efficacy of music therapy for pain has been established, there are no mechanistic studies clarifying how it works in clinical populations. Thus, there is a lack of knowledge related to 1) therapeutic mechanisms that lead to improvement (mediator effects) and 2) the relationship between patient characteristics and treatment response (moderator effects). Yet, it is well accepted that knowledge of mediators and moderators as well as a validated theory of action (i.e., how the intervention activates the mediators) are needed to optimize psychosocial treatment interventions. Therefore, the overarching goals of this study are to 1) examine mediators and moderators hypothesized to account for the pain-reducing effects of Interactive Music Therapy (IMT) in people with advanced cancer and chronic pain and 2) validate IMT's theory of action. The mediation model to be tested in this study aligns with a biopsychosocial framework to palliation of chronic pain and is based on findings from a preliminary study. The investigators postulate that anxiety, mood, self-efficacy and perceived support mediate the effects of IMT on pain outcomes (i.e. pain intensity and pain interference). In addition, the impact of several moderators on the hypothesized mediation model, namely adult playfulness, perceived musical competence, and treatment expectancy, will be tested. This 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. A total of 100 outpatients with advanced cancer and chronic bone pain will be randomized to one of two 6-week treatments: 1) Interactive Music Therapy or 2) Verbal-based support. The mediators and pain outcomes will be measured at baseline and after the fourth and sixth session using self-report measures as well as biomarkers (salivary cortisol, lachrymal dopamine content, serum oxytocin, and plasma β-endorphins). Follow-up interviews with a subsample of 30 participants will enable the investigators to examine the congruence between the hypothesized mediators and moderators and participant explanations of how IMT influences chronic pain management (i.e. theory of action). This study will contribute towards the optimization of music therapy for palliation of chronic pain in people with advanced cancer through a better understanding of the impact of mediators and moderators of IMT on chronic pain management. The results of this study will provide estimated effects sizes of IMT on the mediators and preliminary effect size estimates for the pain outcomes. This information will be instrumental in the development of a subsequent large-scale efficacy trial.
- Conditions
- Advanced Cancer
- Being tested
- Interactive Music Therapy, Verbal support
- Keywords
- music therapy, bone pain, pain management, advanced cancer
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Music TherapyBehavioural
Six 45-minute individual interactive music therapy (IMT) sessions delivered by a board-certified music therapist. Sessions start with music-guided breathing, imagery, or humming. The music therapist then engages the participant in singing of familiar songs and co-created vocal or instrumental music improvisations based on patient needs. Discussion about the meaning assigned to songs and emotions expressed through the improvisations follow. The IMT experiences are aimed at facilitating emotional expression, offering support through interactive music making, and strengthening inner resources of creativity. In addition, each week the participant learns music-based techniques for self-management of anxiety, stress, mood, and pain.
Verbal supportBehavioural
Six 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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Music Therapy | Experimental | Six 45-minute individual interactive music therapy sessions. Receives: Behavioral: Interactive Music Therapy |
| Verbal-based support | Active comparator | Six 45-minute individual verbal support sessions Receives: Behavioral: Verbal support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
measured by PROMIS® Pain Intensity-Short Form (SF)3a
Measured: through study completion, a maximum of 12 weeks
Pain Interference
measured by PROMIS® Cancer-Pain Interference -SF 6b
Measured: through study completion, a maximum of 12 weeks
Patient Perception of Change
measured by Patient Global Impression of Change Scale (PGIC)
Measured: through study completion, a maximum of 12 weeks
Serum β-endorphin
biomarker for pain intensity
Measured: through study completion, a maximum of 12 weeks
Secondary outcomes (7)
Anxiety
Mediator outcome measured by PROMIS® Cancer-Anxiety - SF
Measured: through study completion, a maximum of 12 weeks
Mood
Mediator outcome measured by Positive and Negative Affect Scale (PANAS)
Measured: through study completion, a maximum of 12 weeks
Perceived support
Mediator outcome measured by PROMIS® Emotional Support - SF 6a
Measured: through study completion, a maximum of 12 weeks
Self-efficacy
Mediator outcome measured by PROMIS® Self-Efficacy of Symptoms
Measured: through study completion, a maximum of 12 weeks
Salivary cortisol
Mediator outcome (biomarker for anxiety)
Measured: through study completion, a maximum of 12 weeks
Serum oxytocin
Mediator outcome (biomarker for social support)
Measured: through study completion, a maximum of 12 weeks
Lachrymal dopamine
Mediator outcome (biomarker for mood)
Measured: through study completion, a maximum of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Feb 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Joke Bradt, Drexel University
- Investigators
- Joke Bradt, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432247
- Sponsor's protocol ID
- R01NR016681
- Other IDs
- 1R01NR016681-01A1
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 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.
Publications
Bradt J, Leader A, Worster B, Myers-Coffman K, Bryl K, Biondo J, Schneible B, Cottone C, Selvan P, Zhang F. Music Therapy for Pain Management for People With Advanced Cancer: A Randomized Controlled Trial. Psychooncology. 2024 Oct;33(10):e70005. doi: 10.1002/pon.70005.
PubMed 39450934
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
- Mechanisms of Music Therapy to Palliate Pain in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT03432247
- Acronym / sponsor ID
- R01NR016681
- Conditions
- Advanced Cancer
- Keywords
- music therapy, bone pain, pain management, advanced cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Feb 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.
Chronic pain is one of the most feared symptoms in people with cancer. Insufficient relief from pharmacological treatments and the fear of side effects are important reasons for the growing use of complementary pain management approaches in cancer care. On such approach is music therapy. Although several studies have demonstrated that music therapy interventions can reduce pain in people with cancer, few studies have examined the therapeutic mechanisms that explain how music therapy interventions lead to improved pain management. The purpose of this study is to examine whether an interactive music therapy intervention improves psychological and social factors that play an important role in chronic pain management in people with advanced cancer. The findings will contribute towards the optimization of music therapy for palliation of chronic pain in people with advanced cancer.
Detailed description
This study addresses the public health problem of chronic pain as one of the most feared symptoms in people with cancer, with 70% to 90% of patients with advanced disease reporting pain. Unrelieved pain remains a challenge in cancer care. Insufficient relief from pharmacological treatments and the fear of side effects are important reasons for the growing use of complementary pain management approaches in people with cancer. One such approach is music therapy. Although efficacy of music therapy for pain has been established, there are no mechanistic studies clarifying how it works in clinical populations. Thus, there is a lack of knowledge related to 1) therapeutic mechanisms that lead to improvement (mediator effects) and 2) the relationship between patient characteristics and treatment response (moderator effects). Yet, it is well accepted that knowledge of mediators and moderators as well as a validated theory of action (i.e., how the intervention activates the mediators) are needed to optimize psychosocial treatment interventions. Therefore, the overarching goals of this study are to 1) examine mediators and moderators hypothesized to account for the pain-reducing effects of Interactive Music Therapy (IMT) in people with advanced cancer and chronic pain and 2) validate IMT's theory of action. The mediation model to be tested in this study aligns with a biopsychosocial framework to palliation of chronic pain and is based on findings from a preliminary study. The investigators postulate that anxiety, mood, self-efficacy and perceived support mediate the effects of IMT on pain outcomes (i.e. pain intensity and pain interference). In addition, the impact of several moderators on the hypothesized mediation model, namely adult playfulness, perceived musical competence, and treatment expectancy, will be tested. This 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. A total of 100 outpatients with advanced cancer and chronic bone pain will be randomized to one of two 6-week treatments: 1) Interactive Music Therapy or 2) Verbal-based support. The mediators and pain outcomes will be measured at baseline and after the fourth and sixth session using self-report measures as well as biomarkers (salivary cortisol, lachrymal dopamine content, serum oxytocin, and plasma β-endorphins). Follow-up interviews with a subsample of 30 participants will enable the investigators to examine the congruence between the hypothesized mediators and moderators and participant explanations of how IMT influences chronic pain management (i.e. theory of action). This study will contribute towards the optimization of music therapy for palliation of chronic pain in people with advanced cancer through a better understanding of the impact of mediators and moderators of IMT on chronic pain management. The results of this study will provide estimated effects sizes of IMT on the mediators and preliminary effect size estimates for the pain outcomes. This information will be instrumental in the development of a subsequent large-scale efficacy 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 TherapySix 45-minute individual interactive music therapy sessions. |
| Verbal-based support | Active comparator | Behavioral: Verbal supportSix 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 (5 listed)
- male or female outpatients with advanced cancer (Stage 3 \& 4; or relapse refractory patients for myeloma)
- diagnosed with locally advanced cancer that has extended to organs/soft tissue or is impinging on or eroding the bone; or bone metastases or soft tissue metastasis
- moderate to severe pain with an average intensity ≥4 on a 0-10 Numeric Rating Scale (NRS)
- experiencing pain for ≥ 3 months
- Karnofsky Performance score of ≥ 60 or the Eastern Cooperative Group Performance Status (ECOG) equivalent of ≤ 2 (i.e. requires occasional assistance, but is able to care for most of their personal needs)
Key exclusion criteria (9 listed)
- expected survival ≤ 3 months
- primary central nervous system (CNS) tumor or CNS metastatic disease that impairs concentration, memory, balance or focus that would preclude ability to participate in a 60 minute, recurring activity and completion of self-report measures
- hematologic malignancies except for myeloma which causes significant bone pain
- ≤ 3 weeks post-operation from start of study
- active psychosis or dementia
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 TherapySix 45-minute individual interactive music therapy (IMT) sessions delivered by a board-certified music therapist. Sessions start with music-guided breathing, imagery, or humming. The music therapist then engages the participant in singing of familiar songs and co-created vocal or instrumental music improvisations based on patient needs. Discussion about the meaning assigned to songs and emotions expressed through the improvisations follow. The IMT experiences are aimed at facilitating emotional expression, offering support through interactive music making, and strengthening inner resources of creativity. In addition, each week the participant learns music-based techniques for self-management of anxiety, stress, mood, and pain. | Behavioural | Interactive Music Therapy |
| Verbal supportSix 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. | Behavioural | Verbal-based support |
Primary outcome
Pain Intensity
Time frame: through study completion, a maximum of 12 weeks
measured by PROMIS® Pain Intensity-Short Form (SF)3a
Pain Interference
Time frame: through study completion, a maximum of 12 weeks
measured by PROMIS® Cancer-Pain Interference -SF 6b
Patient Perception of Change
Time frame: through study completion, a maximum of 12 weeks
measured by Patient Global Impression of Change Scale (PGIC)
Serum β-endorphin
Time frame: through study completion, a maximum of 12 weeks
biomarker for pain intensity
7 secondary outcomes
Anxiety
Time frame: through study completion, a maximum of 12 weeks
Mood
Time frame: through study completion, a maximum of 12 weeks
Perceived support
Time frame: through study completion, a maximum of 12 weeks
Self-efficacy
Time frame: through study completion, a maximum of 12 weeks
Salivary cortisol
Time frame: through study completion, a maximum of 12 weeks
Serum oxytocin
Time frame: through study completion, a maximum of 12 weeks
Lachrymal dopamine
Time frame: through study completion, a maximum of 12 weeks
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.
- Derived from this study: PubMed 39450934Bradt J, Leader A, Worster B, Myers-Coffman K, Bryl K, Biondo J, Schneible B, Cottone C, Selvan P, Zhang F. Music Therapy for Pain Management for People With Advanced Cancer: A Randomized Controlled Trial. Psychooncology. 2024 Oct;33(10):e70005. doi: 10.1002/pon.70005.
- 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 support in people with Advanced Cancer, 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 5 inclusion and 9 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?
Pain Intensity (time frame: through study completion, a maximum of 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03432247, which also lists 1 linked publication.
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.