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Feasibility and Acceptability of Empowered Relief for American Indians With Pain During and After Cancer Treatment (ejames3)

16. september 2026 opdateret af: University of Oklahoma
This project will evaluate the feasibility and acceptability of Empowered Relief (ER) among American Indian adults who are currently receiving or have completed active cancer treatments at Stephenson Cancer Center (SCC). ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. Because of its brief, didactic nature and Zoom delivery, ER can accommodate large class sizes and may address accessibility disparities among underserved cancer populations. While ER is being studied across various non-cancer populations and has been adopted as standard of care in leading healthcare institutions in the U.S. and abroad, it has not been tested in American Indians with cancer.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Stephenson Cancer Center - Tulsa Location
        • Kontakt:

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Identifies as American Indian
  • Has history of a cancer diagnosis
  • Is currently undergoing or has completed active cancer treatment
  • Experiences body pain most or every day
  • Pain duration at least 3 months
  • English fluency

Exclusion Criteria:

  • Significant psychological and cognitive impairment that limits one's ability to complete study tasks (completion of online survey, attending the Zoom-based ER class)
  • Life-threatening acute illness (e.g., infection, heart attack, injury)
  • No access to a computer, a smartphone, or a tablet

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Empowered Relief
Participants in this arm will complete a 2-hour Empowered Relief pain management course and get access to all the course materials. Participants will complete a series of follow-up surveys assessing the feasibility of the class for their pain intervention.
Adfærdsmæssigt: Empowered Relief
ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Identify areas for cultural tailoring and improvement of ER
Tidsramme: Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
We will use qualitative data from interviews to generate actionable recommendations to improve the cultural engagement, acceptability, and relevance of ER for American Indians with cancer.
Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
Feasibility of ER in American Indian populations
Tidsramme: From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)

Indexed by:

  • ≥70% attendance rate amongst all eligible participants
  • An average treatment satisfaction rating of ≥ 8 on a 0-10 scale (with 0 being completely dissatisfied and 10 being completely satisfied)
  • Successful recruitment and completion of 70 participants within one year

Measures will be factored together to make an assessment on total feasibility.
From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)
Pain Intensity
Tidsramme: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class
Pain intensity will be reported on a scale from 1-10, with 1 being "No Pain" and 10 being "Worst Pain Imaginable."
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class
Pain Interference
Tidsramme: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Pain interference will be gauged using a series of questions decerning the impact of the participants participants pain on daily activities. Participants will rate the interference on a scale from 1-5, with 1 being "Not at All" and 5 being "Very Much."
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Emotional Distress
Tidsramme: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Emotional distress will be measured using a series of questionnaires asking participants about the frequency of certain emotional reactions. Participants will report frequency on a scale from 1-5, with 1 being "Never" and 5 being "Always."
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Sleep Disturbance
Tidsramme: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Sleep Disturbance will be recorded using a series of questions rating the quality and frequency of sleep. Participants will report on quality and frequency on a scale from 1-5, with 1 being "Very Poor/Not at All" and 5 being "Very Good/Very Much."
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Perceived Quality of Life
Tidsramme: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Perceived Quality of Life will be reported on a scale from 1-5, with 1 being "Poor" and 5 being "Excellent."
Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.

Samarbejdspartnere og efterforskere

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

Sponsor

University of Oklahoma

Efterforskere

  • Ledende efterforsker: Sophia You, University of Oklahoma

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 (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

20. juli 2026

Først indsendt, der opfyldte QC-kriterier

28. juli 2026

Først opslået (Faktiske)

3. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20065Ph1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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