Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services

Pain Clinical Trial

— PRACXIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905720
• Other study ID #: 17-23446
• Secondary ID: NCI-2018-0220418
• Status: Completed
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Solid Tumor
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)
Secondary	Presence and severity of common side effects	Nausea, vomiting, agitation, and sedation	Daily for up to four hospital days
Secondary	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
Secondary	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