Clinical trial NCT03905720: Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services
Official title: Non-pharmacologic Approaches to Relieve Pain and Symptom Distress Among Diverse Hospitalized Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Solid Tumor
Pain
Keywords: cancer
inpatient
non-pharmacologic approaches
pain management
acupuncture
pain counseling
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2019-04-05
Enrollment: 448
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 randomized factorial design
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in worst pain intensity assessed by the NRS
timeFrame: Daily for up to four hospital days
Secondary outcomes:
measure: Use of opioids during hospital stay
timeFrame: Hospital stay (average length of stay = 5 days)
measure: Presence and severity of common side effects
timeFrame: Daily for up to four hospital days
measure: Cancer-related distress
timeFrame: Daily for up to four hospital days
measure: Health-related quality of life assessed by the EuroQol EQ-5D-3L (EQ-5D-3L)
timeFrame: Daily for up to four hospital days
Other outcomes:
measure: Pain Treatment Satisfaction Scale
timeFrame: Assessed once at the end of hospital stay (average length of stay = 5 days)
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Maria T Chao, DrPH, MPA
role: PRINCIPAL_INVESTIGATOR
References: