Uma Intervenção Personalizada de Promoção da Adesão à Medicação para Adolescentes e Jovens Adultos com Cancro
Uma Intervenção Personalizada para Promover a Adesão à Medicação em Adolescentes e Jovens Adultos com Cancro
The goal of this clinical trial is to learn if a tailored intervention can help make it easier for adolescents and young adults with cancer to take their medications. The main questions the researchers are trying to answer are:
- Does the tailored intervention increase adherence?
- Does the tailored intervention improve quality of life?
- Does the tailored intervention reduce health care utilization?
The researchers will compare the tailored intervention to a uniform standard of care intervention (an intervention designed to be similar to what is currently happening in clinical care) to see if the tailored intervention works to improve adherence.
Participants will:
- Use an electronic pill bottle or box to store their medication
- Participate in intervention sessions
- Complete surveys before the intervention, after the intervention, and 6-months later
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The proposed research includes a randomized clinical trial of a tailored adherence-promotion intervention (Tailored Program) as compared to uniform standard of care (Feedback Program) for adolescents and young adults with cancer. As part of this study, up to 160 adolescents and young adults (AYAs) with cancer will be randomized to one of these groups. Participants who enroll in this trial will be given an electronic pill bottle or box with a computer chip to store their medication. After using the electronic monitor for a few weeks to assess baseline adherence, participants who demonstrate non-adherence and have used the electronic monitor without difficulty will be asked to complete pre-treatment questionnaires. Next, participants will be randomly assigned to one of the two groups and complete their assigned program. Adolescents and young adults will continue to use the electronic monitor to store their medication until approximately a month after their program ends. After their program ends, participants will complete questionnaires at post-treatment and again about 6 months later.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Meghan E. McGrady, PhD
- Número de telefone: 513-803-8044
- E-mail: Meghan.McGrady@cchmc.org
Locais de estudo
-
-
Kansas
-
Kansas City, Kansas, Estados Unidos, 66160
- Ainda não está recrutando
- The University of Kansas Medical Center
-
Contato:
- Carolyn Bates, PhD
- E-mail: cbates4@kumc.edu
-
-
New York
-
New York, New York, Estados Unidos, 1003230702
- Ainda não está recrutando
- Columbia University Irving Medical Center
-
Contato:
- Melissa Beauchemin, PhD
- E-mail: mmp2123@cumc.columbia.edu
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45229
- Recrutamento
- Cincinnati Children's Hospital Medical Center
-
Contato:
- Meghan E McGrady, PhD
- Número de telefone: 513-803-8044
- E-mail: Meghan.McGrady@cchmc.org
-
-
Washington
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Seattle, Washington, Estados Unidos, 98105
- Recrutamento
- Seattle Children's Hospital
-
Contato:
- Tyler Ketterl, MD
- E-mail: Tyler.Ketterl@seattlechildrens.org
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patient is 15.00 to 24.99 years of age
- Patient is diagnosed with cancer
- Patient is prescribed an oral anticancer/antitumor agent or prophylaxis
Exclusion Criteria:
- Patient is not fluent in English
- Patient evidences significant cognitive deficits
- Patient's medical status or treatment precludes participation
- Patient enrolled on a medical trial requiring medication storage in a trial-provided container
- Patient demonstrates greater than or equal to 95% adherence during run-in period
- Patient declines to use or has difficulty using electronic adherence monitoring device during run-in
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Tailored Program
8-week program including 4 coach visits and 4 text check-ins |
Participants will participate in 4 sessions with a coach, 1 every other week. During these sessions, the participant will work with their coach to identify a barrier to adherence they would like to target. Then, they will work with their coach to create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text reminder about the plan. |
|
Outro: Feedback Program (Uniform Standard of Care)
8-week feedback program including weekly texts |
Participants will receive weekly text messages with feedback about their adherence and guidance for requesting additional support if desired |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Medication Adherence
Prazo: The 1-month period following the completion of one of the study programs.
|
Each participant will be given an electronic adherence monitoring device to store their medication. An electronic adherence monitoring device is a pill bottle or box with an embedded computer chip. The computer chip records each time the device is opened. These device openings, or actuations, will be compared with the patient's prescribed medication regimen to compute their adherence (defined as the percentage of doses taken as prescribed). |
The 1-month period following the completion of one of the study programs.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of Life (Mental Health)
Prazo: Approximately 1 month after completing one of the study programs
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Mental Health 2a. Raw score range = 2-10. Higher scores = better quality of life. |
Approximately 1 month after completing one of the study programs
|
|
Quality of Life (Physical Health)
Prazo: Approximately 1 month after completing one of the study programs
|
PROMIS (Patient-Reported Outcomes Measurement Information System) Global Physical Health 2a. Raw score range = 2-10. Higher scores = better quality of life. |
Approximately 1 month after completing one of the study programs
|
|
Healthcare Utilization
Prazo: 6 months post-treatment
|
Number of oncology visits, lab draws, ED visits, and hospitalizations |
6 months post-treatment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Meghan E. McGrady, PhD, Children's Hospital Medical Center, Cincinnati
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
- R37CA302422 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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