Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services (PRACXIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Malignant Solid Tumor
• Intervention / Treatment: Procedure: Acupuncture; Behavioral: Pain Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 448
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients admitted to University of California San Francisco (UCSF) or Zuckerberg San Francisco General (ZSFG) with a malignant solid tumor
2. Speak Cantonese, English, or Spanish
3. Have an anticipated stay of ≥ 48 hours
4. Be aged 21 or older
5. Have pain intensity of ≥ 4 out of 10 for worst pain in the prior 24 hours when enrolled

Exclusion Criteria:

1. Acupuncture contraindication
2. Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction)
3. Admission to the psychiatric ward (e.g., for severe depression)
4. Inability to consent (e.g., cognitive impairment)
5. Prior involvement with the study (e.g., readmissions)
6. Platelets < 50,000 microliters
7. Absolute neutrophil count < 500 microliters
8. C. difficile infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment As Usual; Participants will receive routine care consisting of usual analgesic medications for pain in adults with cancer.
Active Comparator: Acupuncture; Along with routine pain medications, participants will be offered daily acupuncture treatments for up to four days.	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.
Active Comparator: Pain Counseling; Along with routine pain medications, participants will receive evidence-based psychosocial support through education and counseling provided by qualified study staff.	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.
Active Comparator: Acupuncture and Pain Counseling; Along with routine pain medications, participants will be offered daily acupuncture treatments and pain counseling for up to four days as described above.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in worst pain intensity assessed by the NRS	Participants' worst level of pain in the past 24 hours on a 0-10 numeric rating scale (NRS), 0= no pain and 10= worst pain imaginable	Daily for up to four hospital days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of opioids during hospital stay	Total and average daily use of opioids based on morphine milligram equivalence	Hospital stay (average length of stay = 5 days)
Presence and severity of common side effects	Nausea, vomiting, agitation, and sedation	Daily for up to four hospital days
Cancer-related distress	Single item measure developed by the National Comprehensive Cancer Network. Participants are asked to indicate the number that best describes how much distress they are experiencing in the past week including today, 0=no distress and 10=extreme distress.	Daily for up to four hospital days
Health-related quality of life assessed by the EuroQol EQ-5D-3L (EQ-5D-3L)	The EuroQol EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. The EuroQol visual analogue scale (EQ VAS) records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. Detailed scoring instructions are available: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-3L_UserGuide_2015.pdf	Daily for up to four hospital days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Treatment Satisfaction Scale	The Pain Treatment Satisfaction Scale includes subscales of satisfaction with information, medical care, effectiveness, and side effects with reliability ranging from 0.83 to 0.92. Each of the subscales are scored from 0 to 100 with higher scores indicating greater satisfaction.	Assessed once at the end of hospital stay (average length of stay = 5 days)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Maria T Chao, DrPH, MPA, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: cancer; acupuncture; pain management; inpatient; non-pharmacologic approaches; pain counseling
• Other Study ID Numbers: 17-23446; NCI-2018-02204 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP)); 18801 (University of California, San Francisco)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No