Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services (PRACXIS)
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ClinicalTrials.gov Identifier: NCT03905720 |
Recruitment Status :
Completed
First Posted : April 5, 2019
Last Update Posted : October 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Malignant Solid Tumor Pain | Procedure: Acupuncture Behavioral: Pain Counseling | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 448 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Intervention Model Description: | 2x2 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 : | January 17, 2019 |
Actual Primary Completion Date : | September 30, 2021 |
Actual Study Completion Date : | September 30, 2021 |
Arm | Intervention/treatment |
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No Intervention: Treatment As Usual
Participants will receive routine care consisting of usual analgesic medications for pain in adults with cancer.
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Active Comparator: Acupuncture
Along with routine pain medications, participants will be offered daily acupuncture treatments for up to four days.
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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.
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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.
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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. |
- Change in worst pain intensity assessed by the NRS [ Time Frame: 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
- Use of opioids during hospital stay [ Time Frame: 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 [ Time Frame: Daily for up to four hospital days ]Nausea, vomiting, agitation, and sedation
- Cancer-related distress [ Time Frame: 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) [ Time Frame: 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
- Pain Treatment Satisfaction Scale [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- C. difficile infection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905720
United States, California | |
Zuckerberg San Francisco General Hospital | |
San Francisco, California, United States, 94110 | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Maria T Chao, DrPH, MPA | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT03905720 |
Other Study ID Numbers: |
17-23446 NCI-2018-02204 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) ) 18801 ( Other Identifier: University of California, San Francisco ) |
First Posted: | April 5, 2019 Key Record Dates |
Last Update Posted: | October 22, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
cancer inpatient non-pharmacologic approaches |
pain management acupuncture pain counseling |