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

21. oktober 2021 opdateret af: University of California, San Francisco

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

448

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94143
        • University of California, San Francisco
      • San Francisco, California, Forenede Stater, 94110
        • Zuckerberg San Francisco General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Treatment As Usual
Participants will receive routine care consisting of usual analgesic medications for pain in adults with cancer.
Aktiv komparator: 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.
Aktiv komparator: Pain Counseling
Along with routine pain medications, participants will receive evidence-based psychosocial support through education and counseling provided by qualified study staff.
Adfærdsmæssigt: 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.
Aktiv komparator: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in worst pain intensity assessed by the NRS
Tidsramme: 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
Daily for up to four hospital days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Use of opioids during hospital stay
Tidsramme: Hospital stay (average length of stay = 5 days)
Total and average daily use of opioids based on morphine milligram equivalence
Hospital stay (average length of stay = 5 days)
Presence and severity of common side effects
Tidsramme: Daily for up to four hospital days
Nausea, vomiting, agitation, and sedation
Daily for up to four hospital days
Cancer-related distress
Tidsramme: 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.
Daily for up to four hospital days
Health-related quality of life assessed by the EuroQol EQ-5D-3L (EQ-5D-3L)
Tidsramme: 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
Daily for up to four hospital days

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Treatment Satisfaction Scale
Tidsramme: 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.
Assessed once at the end of hospital stay (average length of stay = 5 days)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Samarbejdspartnere

Patient-Centered Outcomes Research Institute

Efterforskere

  • Ledende efterforsker: Maria T Chao, DrPH, MPA, University of California, San Francisco

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. januar 2019

Primær færdiggørelse (Faktiske)

30. september 2021

Studieafslutning (Faktiske)

30. september 2021

Datoer for studieregistrering

Først indsendt

30. august 2018

Først indsendt, der opfyldte QC-kriterier

3. april 2019

Først opslået (Faktiske)

5. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 17-23446
  • NCI-2018-02204 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
  • 18801 (University of California, San Francisco)

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