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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Malignant Solid Tumor; Pain

Treatments: Procedure: Acupuncture; Behavioral: Pain Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03905720

NCI-2018-02204 (Registry Identifier)

17-23446

18801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 448 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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448 participants in 4 patient groups

Treatment As Usual

No Intervention group

Description:

Participants will receive routine care consisting of usual analgesic medications for pain in adults with cancer.

Acupuncture

Active Comparator group

Description:

Along with routine pain medications, participants will be offered daily acupuncture treatments for up to four days.

Treatment:

Procedure: Acupuncture

Pain Counseling

Active Comparator group

Description:

Along with routine pain medications, participants will receive evidence-based psychosocial support through education and counseling provided by qualified study staff.

Treatment:

Behavioral: Pain Counseling

Acupuncture and Pain Counseling

Active Comparator group

Description:

Along with routine pain medications, participants will be offered daily acupuncture treatments and pain counseling for up to four days as described above.

Treatment:

Procedure: Acupuncture

Behavioral: Pain Counseling