Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Solid Tumor, Pain

Intervention / Treatment
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* Procedure: Acupuncture
* Behavioral: Pain Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2x2 randomized factorial design
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-pharmacologic approaches, pain management, acupuncture, pain counseling, cancer, inpatient