Feasibility and Acceptability of Empowered Relief for American Indians With Pain During and After Cancer Treatment (ejames3)
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jordan Keast
- Número de telefone: 405-615-1474
- E-mail: jordan-keast@ou.edu
Locais de estudo
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74104
- Stephenson Cancer Center - Tulsa Location
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Contato:
- Sophia You
- Número de telefone: 918-660-3925
- E-mail: dokyoung-you@ou.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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. |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility of ER in American Indian populations
Prazo: From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)
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Indexed by:
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)
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Identify areas for cultural tailoring and improvement of ER
Prazo: Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
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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)
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Pain Intensity
Prazo: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class
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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
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Pain Interference
Prazo: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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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.
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Emotional Distress
Prazo: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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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.
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Sleep Disturbance
Prazo: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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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.
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Perceived Quality of Life
Prazo: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
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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.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sophia You, University of Oklahoma
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20065Ph1
Plano para dados de participantes individuais (IPD)
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