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Pain Management Support Study for Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03432247
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : February 21, 2022
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Joke Bradt, Drexel University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Behavioral: Interactive Music Therapy Behavioral: Verbal support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mechanisms of Music Therapy to Palliate Pain in Patients With Advanced Cancer
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interactive Music Therapy
Six 45-minute individual interactive music therapy sessions.
Behavioral: Interactive Music Therapy
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.

Active Comparator: Verbal-based support
Six 45-minute individual verbal support sessions
Behavioral: Verbal support
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.




Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: through study completion, a maximum of 12 weeks ]
    measured by PROMIS® Pain Intensity-Short Form (SF)3a

  2. Pain Interference [ Time Frame: through study completion, a maximum of 12 weeks ]
    measured by PROMIS® Cancer-Pain Interference -SF 6b

  3. Patient Perception of Change [ Time Frame: through study completion, a maximum of 12 weeks ]
    measured by Patient Global Impression of Change Scale (PGIC)

  4. Serum β-endorphin [ Time Frame: through study completion, a maximum of 12 weeks ]
    biomarker for pain intensity


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: through study completion, a maximum of 12 weeks ]
    Mediator outcome measured by PROMIS® Cancer-Anxiety - SF

  2. Mood [ Time Frame: through study completion, a maximum of 12 weeks ]
    Mediator outcome measured by Positive and Negative Affect Scale (PANAS)

  3. Perceived support [ Time Frame: through study completion, a maximum of 12 weeks ]
    Mediator outcome measured by PROMIS® Emotional Support - SF 6a

  4. Self-efficacy [ Time Frame: through study completion, a maximum of 12 weeks ]
    Mediator outcome measured by PROMIS® Self-Efficacy of Symptoms

  5. Salivary cortisol [ Time Frame: through study completion, a maximum of 12 weeks ]
    Mediator outcome (biomarker for anxiety)

  6. Serum oxytocin [ Time Frame: through study completion, a maximum of 12 weeks ]
    Mediator outcome (biomarker for social support)

  7. Lachrymal dopamine [ Time Frame: through study completion, a maximum of 12 weeks ]
    Mediator outcome (biomarker for mood)


Other Outcome Measures:
  1. Treatment expectancy [ Time Frame: Baseline ]
    Moderator outcome measured by Credibility/Expectancy Questionnaire (CEQ)

  2. Perceived Musical Competence [ Time Frame: Baseline ]
    Moderator outcome measured by two-item questionnaire

  3. Adult playfulness [ Time Frame: Baseline ]
    Moderator outcome measured by Short Measure for Adult Playfulness (SMAP)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • moderate to severe hearing impairment
  • current smoking
  • current alcohol dependence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432247


Locations
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United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
Thomas Jefferson Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Cancer Treatment Centers of America (CTCA)
Philadelphia, Pennsylvania, United States, 19124
Sponsors and Collaborators
Drexel University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Joke Bradt, PhD Drexel University
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Responsible Party: Joke Bradt, Professor, Drexel University
ClinicalTrials.gov Identifier: NCT03432247    
Other Study ID Numbers: R01NR016681 ( U.S. NIH Grant/Contract )
1R01NR016681-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 21, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: After completion of study report and publication of results
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joke Bradt, Drexel University:
music therapy
bone pain
pain management
advanced cancer
Additional relevant MeSH terms:
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Neoplasms