PRACXIS: Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT03905720

Collaborator

Patient-Centered Outcomes Research Institute (Other)

448

Enrollment

Locations

Arms

32.4

Actual Duration (Months)

224

Patients Per Site

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Solid Tumor Pain	Procedure: Acupuncture Behavioral: Pain Counseling	N/A

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:

Determine the effectiveness of adjunctive acupuncture and of pain counseling for improving pain management.
Determine the extent that adjunctive acupuncture and pain counseling reduce use of opioid analgesics and side effects.
Examine stakeholder perspectives on non-pharmacologic approaches to pain management.

Study Design

Study Type:

Interventional

Actual Enrollment :

448 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

2x2 randomized factorial design2x2 randomized factorial design

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 17, 2019

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Change in worst pain intensity assessed by the NRS [Daily for up to four hospital days]
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

Secondary Outcome Measures

Use of opioids during hospital stay [Hospital stay (average length of stay = 5 days)]
Total and average daily use of opioids based on morphine milligram equivalence
Presence and severity of common side effects [Daily for up to four hospital days]
Nausea, vomiting, agitation, and sedation
Cancer-related distress [Daily for up to four hospital days]
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.
Health-related quality of life assessed by the EuroQol EQ-5D-3L (EQ-5D-3L) [Daily for up to four hospital days]
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

Other Outcome Measures

Pain Treatment Satisfaction Scale [Assessed once at the end of hospital stay (average length of stay = 5 days)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zuckerberg San Francisco General Hospital	San Francisco	California	United States	94110
2	University of California, San Francisco	San Francisco	California	United States	94143