Advanced Cancer Clinical Trial
Official title:
Mechanisms of Music Therapy to Palliate Pain in Patients With Advanced Cancer
Verified date | February 2022 |
Source | Drexel University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cancer Treatment Centers of America (CTCA) | Philadelphia | Pennsylvania |
United States | Hahnemann University Hospital | Philadelphia | Pennsylvania |
United States | Thomas Jefferson Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Drexel University | National Institute of Nursing Research (NINR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Treatment expectancy | Moderator outcome measured by Credibility/Expectancy Questionnaire (CEQ) | Baseline | |
Other | Perceived Musical Competence | Moderator outcome measured by two-item questionnaire | Baseline | |
Other | Adult playfulness | Moderator outcome measured by Short Measure for Adult Playfulness (SMAP) | Baseline | |
Primary | Pain Intensity | measured by PROMIS® Pain Intensity-Short Form (SF)3a | through study completion, a maximum of 12 weeks | |
Primary | Pain Interference | measured by PROMIS® Cancer-Pain Interference -SF 6b | through study completion, a maximum of 12 weeks | |
Primary | Patient Perception of Change | measured by Patient Global Impression of Change Scale (PGIC) | through study completion, a maximum of 12 weeks | |
Primary | Serum ß-endorphin | biomarker for pain intensity | through study completion, a maximum of 12 weeks | |
Secondary | Anxiety | Mediator outcome measured by PROMIS® Cancer-Anxiety - SF | through study completion, a maximum of 12 weeks | |
Secondary | Mood | Mediator outcome measured by Positive and Negative Affect Scale (PANAS) | through study completion, a maximum of 12 weeks | |
Secondary | Perceived support | Mediator outcome measured by PROMIS® Emotional Support - SF 6a | through study completion, a maximum of 12 weeks | |
Secondary | Self-efficacy | Mediator outcome measured by PROMIS® Self-Efficacy of Symptoms | through study completion, a maximum of 12 weeks | |
Secondary | Salivary cortisol | Mediator outcome (biomarker for anxiety) | through study completion, a maximum of 12 weeks | |
Secondary | Serum oxytocin | Mediator outcome (biomarker for social support) | through study completion, a maximum of 12 weeks | |
Secondary | Lachrymal dopamine | Mediator outcome (biomarker for mood) | through study completion, a maximum of 12 weeks |
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