Pain Management Support Study for Patients With Advanced Cancer

NCT03432247 | Completed

• 2 other identifiers: R01NR0166811R01NR016681-01A1
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Cancer

Keywords

music therapy; bone pain; pain management; advanced cancer

Outcome Measures

Primary Outcomes (4)

• Pain Intensity

  measured by PROMIS® Pain Intensity-Short Form (SF)3a

  through study completion, a maximum of 12 weeks

• Pain Interference

  measured by PROMIS® Cancer-Pain Interference -SF 6b

  through study completion, a maximum of 12 weeks

• Patient Perception of Change

  measured by Patient Global Impression of Change Scale (PGIC)

  through study completion, a maximum of 12 weeks

• Serum β-endorphin

  biomarker for pain intensity

  through study completion, a maximum of 12 weeks

Secondary Outcomes (7)

• Anxiety

  through study completion, a maximum of 12 weeks

• Mood

  through study completion, a maximum of 12 weeks

• Perceived support

  through study completion, a maximum of 12 weeks

• Self-efficacy

  through study completion, a maximum of 12 weeks

• Salivary cortisol

  through study completion, a maximum of 12 weeks

Other Outcomes (3)

• Treatment expectancy

  Baseline

• Perceived Musical Competence

  Baseline

• Adult playfulness

  Baseline

Study Arms (2)

Interactive Music Therapy

EXPERIMENTAL

Six 45-minute individual interactive music therapy sessions.

Behavioral: Interactive Music Therapy

Verbal-based support

ACTIVE COMPARATOR

Six 45-minute individual verbal support sessions

Behavioral: Verbal support

Interventions

Interactive Music Therapy BEHAVIORAL

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.

Interactive Music Therapy

Verbal support BEHAVIORAL

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.

Verbal-based support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (3)

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

Thomas Jefferson Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

Location

Cancer Treatment Centers of America (CTCA)

Philadelphia, Pennsylvania, 19124, United States

Location

Related Publications (1)

• 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.

  PMID: 39450934 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joke Bradt, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 14, 2018
• Study Start: February 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (3)