Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services

Not Applicable

Completed

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	Along with routine pain medications, participants will be offered daily acupuncture treatments for up to four days.
Acupuncture and Pain Counseling	Acupuncture	Along with routine pain medications, participants will be offered daily acupuncture treatments and pain counseling for up to four days as described above.
Pain Counseling	Pain Counseling	Along with routine pain medications, participants will receive evidence-based psychosocial support through education and counseling provided by qualified study staff.
Acupuncture and Pain Counseling	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Locations (2): Zuckerberg San Francisco General Hospital
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San Francisco, California, United States
University of California, San Francisco
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San Francisco, California, United States