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NCT Number: NCT03905720

Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services

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.

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Key information

Conditions

Malignant Solid Tumor Agnosia Neoplasms Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Procedure

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.

Pain Counseling

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Presence and severity of common side effects

    Time frame: Daily for up to four hospital days

    Nausea, vomiting, agitation, and sedation

  3. 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.

  4. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: PRACXIS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 5, 2019
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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