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

16. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74104
        • Stephenson Cancer Center - Tulsa Location
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Oklahoma

Etterforskere

  • Hovedetterforsker: Sophia You, University of Oklahoma

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

20. juli 2026

Først innsendt som oppfylte QC-kriteriene

28. juli 2026

Først lagt ut (Faktiske)

3. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20065Ph1

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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