Pain Management Support Study for Cancer Survivors

NCT03782506 | Completed

• 1 other identifier: 3R01NR016681-02S1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Pain, Chronic; Opioid Use

Keywords

music therapy; pain management; opioid use; cancer survivors

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Through study completion, a maximum of 28 weeks

Secondary Outcomes (8)

• Pain intensity

  At baseline, post-intervention (week 10), and 3-month follow up

• Pain interference

  At baseline, post-intervention (week 10), and 3-month follow up

• Self-efficacy

  At baseline, post-intervention (week 10), and 3-month follow up

• Patient perception of change

  At post-intervention (week 10) and 3-month follow up

• Physician perception of change

  At baseline, post-intervention (week 10), and 3-month follow up

Study Arms (2)

Interactive Music Therapy

EXPERIMENTAL

Ten 45-minute individual interactive music therapy sessions.

Behavioral: Interactive Music Therapy

Verbal-based Support

ACTIVE COMPARATOR

Ten 45-minute individual verbal support sessions.

Behavioral: Verbal-based support

Interventions

Interactive Music Therapy BEHAVIORAL

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.

Interactive Music Therapy

Verbal-based support BEHAVIORAL

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.

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead

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

MeSH Terms

Conditions

Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

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

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: December 17, 2018
• First Posted: December 20, 2018
• Study Start: November 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 the 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)