Summary

for people ages 21 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Maria T Chao

Description

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.

Official Title

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

Details

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.

Keywords

Malignant Solid TumorPaincancerinpatientnon-pharmacologic approachespain managementacupuncturepain counselingAcupuncture and Pain Counseling

Eligibility

You can join if…

Open to people ages 21 years and up

  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

You CAN'T join if...

  1. Acupuncture contraindication (e.g., sepsis)
  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
    1. difficile infection

Locations

  • San Francisco General Hospital not yet accepting patients
    San FranciscoCalifornia94110United States
  • UCSF Mission Bay Hospital accepting new patients
    San FranciscoCalifornia94143United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03905720
Study Type
Interventional
Last Updated