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Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services (PRACXIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03905720
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : May 8, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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 Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 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
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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 EQ-5D [ 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 Outcome Measures:
  1. Pain Treatment Satisfaction Scale [ Time Frame: Assessed once at the end of hospital stay ]
    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
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Acupuncture contraindication
  2. Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction)
  3. Admission to the psychiatric ward (e.g., for severe depression)
  4. Inability to consent (e.g., cognitive impairment)
  5. Prior involvement with the study (e.g., readmissions)
  6. Platelets < 50,000 microliters
  7. Absolute neutrophil count < 500 microliters
  8. C. difficile infection
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Nicole Thompson 415-502-8733 Nicole.Thompson@ucsf.edu

Locations
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United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Principal Investigator: Donald Abrams, MD         
UCSF Mission Bay Hospital Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Maria T Chao, DrPH, MPA         
Sponsors and Collaborators
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Maria T Chao, DrPH, MPA University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03905720    
Other Study ID Numbers: 17-23446
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
cancer
inpatient
non-pharmacologic approaches
 pain management
acupuncture
pain counseling