- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07724041
Feasibility of a Real-world, Financial Psycho-oncology Intervention to Address Cancer-related Financial Distress
The goal of this pilot, feasibility study is to evaluate the feasibility and preliminary impact of a finance-specific psycho-oncology intervention, as well as to explore perceptions of and experiences with this financial psycho-oncology intervention for patients with cancer experiencing financial hardship. The main questions it aims to answer are:
- Is this financial psycho-oncology intervention feasible, acceptable, and appropriate for patients with cancer experiencing financial hardship?
- How can we refine the financial psycho-oncology intervention to best address financial distress for patients with cancer experiencing financial hardship?
Patients enrolled in the intervention will receive 2, 60-minute long, finance-specific psycho-oncology sessions per month over the course of 3 months, for a total of 6 sessions over the course of the intervention. Patients will complete surveys during intervention enrollment and after intervention completion to assess secondary outcomes of financial hardship, psychological distress, stress, and anxiety. Individuals who consent to the financial psycho-oncology intervention will also be invited to participate in a 30-minute semi-structured interview to explore their perceptions of and experiences with the financial psycho-oncology intervention, including concepts of participation and engagement, relevance and acceptability, content and understanding, logistics and practicality, and potential impact.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Hayden Reeves
- Número de telefone: 205-996-4109
- E-mail: haydenreeves@uabmc.edu
Locais de estudo
-
-
Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham
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Contato:
- Hayden Reeves
- Número de telefone: 205-996-4109
- E-mail: haydenreeves@uabmc.edu
-
Investigador principal:
- Courtney Williams, DrPH
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adult patients with cancer receiving treatment at the UAB Medical Oncology and/or UAB Supportive Care clinics
Exclusion Criteria:
- non-English speakers
- patients with non-melanoma skin cancers
- patients with dementia/cognitive impairments
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Patients receiving financial psycho-oncology intervention
|
Program which integrates emotional support, coping strategies, and financial psychoeducation to enhance patients' capacity to cope with both their emotional and financial burdens due to cancer.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment as a measure of feasibility
Prazo: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
50% of contacted patients consenting to participate
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Retention as a measure of feasibility
Prazo: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
70% of consenting patients completing the program per protocol
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Completion as a measure of feasibility
Prazo: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
<15% missing survey data
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Financial hardship
Prazo: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by COmprehensive Score for financial Toxicity (COST)
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Psychological distress
Prazo: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by National Comprehensive Cancer Network Distress Thermometer and Problem List
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Perceived stress
Prazo: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by Perceived Stress Scale (PSS-10)
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Anxiety
Prazo: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by PROMIS Emotional Distress - Anxiety - Short Form 4
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
|
Change in Depression
Prazo: From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
as measured by PROMIS Emotional Distress - Depression - Short Form 4
|
From enrollment to the end of the financial psycho-oncology intervention at 3 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Courtney Williams, DrPH, University of Alabama at Birmingham
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PREP_Williams2026
- UAB (Outro identificador: UAB)
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