NCT03905720

Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services

Non-pharmacologic Approaches to Relieve Pain and Symptom Distress Among Diverse Hospitalized Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 448 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Despite improved assessment and pharmacologic management, cancer pain is still undertreated. Using non-pharmacologic treatments alongside medications may better address patients' total pain experience by relieving physical and psychological symptoms and reducing the adverse effects of drugs. However, our knowledge of the benefits of multidisciplinary approaches in real-world hospital settings is limited. Patients want to know "How can I get the most pain relief with the fewest side effects?" This study proposal is designed to address this question by testing how combining pharmacologic and non-pharmacologic (acupuncture and pain counseling) treatments can: (1) maximize effectiveness, (2) minimize harms, and (3) align with patients' preferences.

Detailed description

This study compares clinically-relevant therapeutic options in two high-volume hospitals (one public, one university) to address the core research question of whether non-pharmacologic approaches improve symptom management among diverse inpatients. Study investigators will assess the effectiveness of acupuncture and of pain counseling independently and in combination. Participants will be randomized to two factors each with two levels, yielding four experimental conditions: (1) standard pharmacologic pain management, (2) pharmacologic pain management + acupuncture, (3) pharmacologic pain management + pain counseling, (4) pharmacologic pain management + acupuncture + pain counseling. Patient outcomes will be assessed using a mixed-methods approach, with validated scales for quantitative measures and qualitative interviews to elicit stakeholder perspectives (patients, caregivers, providers). The study will be conducted as a pragmatic clinical trial at two hospitals to address these aims: 1. Determine the effectiveness of adjunctive acupuncture and of pain counseling for improving pain management. 2. Determine the extent that adjunctive acupuncture and pain counseling reduce use of opioid analgesics and side effects. 3. Examine stakeholder perspectives on non-pharmacologic approaches to pain management.

Conditions

• Malignant Solid Tumor
• Pain

Interventions

Type	Name	Description
PROCEDURE	Acupuncture	A licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol. Treatments will provided daily for up to four hospital days.
BEHAVIORAL	Pain Counseling	Participants will receive sessions with a counselor trained in pain management. The pain counselor will explain, review, and discuss the contents of a Pain Control booklet. Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days.

Timeline

• Start date: 2019-01-17
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2019-04-05
• Last updated: 2021-10-22

Locations

2 sites across 1 country: United States