- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT06652347
Compreendendo as preferências e opiniões dos idosos sobre o uso de avaliações funcionais geriátricas e objetivas para o planejamento do tratamento do câncer.
Facilitating the Engagement and Satisfaction of Older Adults in Their Cancer Care Planning: A Randomized Study to Understand the Preferences and Views of Older Adults Regarding the Use of Geriatric and Objective Functional Assessments for Cancer Treatment Planning
This Interventional clinical study aims to explore how receiving information about their health and physical abilities affects the treatment decisions of older adults. The study will look at whether sharing detailed assessments of their health and functional status helps older adults better understand their condition and make informed decisions about their care.
The main question it aims to answer is if providing this information changes the treatment priorities of older adults, helping them focus on what matters most to them in their medical care.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This randomized, interventional, cancer care delivery trial will test whether receipt of Geriatric Assessment (GA) and Objective Functional Status (OFS) assessment data affects older adults' treatment priorities. It will also assess the preferences of older adults for the collection, sharing, and use of their assessment data. Finally, it will explore whether less fit patients experience a lower level of satisfaction and a greater degree of regret with their decision to undergo anti-cancer therapy. This study will utilize a randomized design where participants will be randomized to either the intervention arm (early sharing of GA and OFS results) or to the control arm (delayed sharing of GA and OFS results). To assess patients' preferences for quality vs quantity of life, the investigators will use the Quality Quantity (QQ) questionnaire. All patients will complete this at baseline and then undergo their GA and OFS assessments. Patients randomized to the intervention group will be provided the results of their GA and OFS assessments, and then complete the QQ Questionnaire for a second time to assess for any changes following receipt of their assessment results. Patients randomized to the control group will undergo the assessments and complete the same questionnaire as the intervention group but will not receive the results of their GA and OFS assessments prior to completing the second QQ Questionnaire. For the control group, assessment results will be shared with patients after completion of the follow-up QQ Questionnaire. After reviewing their assessment results, patients in both groups will then complete a questionnaire that inquire about their preferences for receipt, use, and sharing of their assessment data. It will also inquire about the degree to which receipt of these data affected how they experienced their cancer care.
The Investigators will determine whether sharing of geriatric and OFS assessment results affected patients' treatment priorities by measuring the absolute change from baseline in the QQ questionnaire scores for quantity and quality of life, comparing the change in the intervention versus the control group. The Investigators will also describe patients' preferences for the collection, use and sharing of their assessment data as reported in the preferences questionnaire, both overall and by race/ethnicity. To explore differences in patients' satisfaction with their decision to pursue anti-cancer therapy by functional status level, participants will complete the "Was it Worth It" (WIWI) questionnaire at the first of either 1) the conclusion of their treatment regimen or 2) three months after enrollment. The provider assessment will ask whether patients experienced any of the following: a toxicity of treatment ≥grade 3, treatment dose reduction, treatment interruption, treatment discontinuation, hospitalization, or a decline in performance status.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Zachary Frosch, MD MSHP
- Número de telefone: 215-728-2674
- E-mail: Zachary.Frosch@fccc.edu
Estude backup de contato
- Nome: Leslie J Fortin, MPH
- Número de telefone: 215-214-3996
- E-mail: Leslie.Fortin@fccc.edu
Locais de estudo
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19111
- Recrutamento
- Fox Chase Cancer Center
-
Contato:
- Leslie J Fortin, MPH
- Número de telefone: 215-214-3996
- E-mail: Leslie.Fortin@fccc.edu
-
Contato:
- Gerald T Nkogbu, MBBS, MSc
- Número de telefone: 215-214-5378
- E-mail: gerald.nkogbu@fccc.edu
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Investigador principal:
- Zachary Frosch, MD, MSHP
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age ≥ 65
At the time of study screening either:
- Started a new qualifying index regimen within the last 30 days (inclusive)
- Are being considered for a new qualifying index regimen
Exclusion Criteria:
-
Patients will be excluded if they
- Do not have the capacity to consent to study procedures
- Are unable to complete English language questionnaires
- Are already using an activity tracker on a daily basis (and therefore may be aware of their current level of activity)
- Are enrolled in another study in which physical activity is a substantial part or all of the therapeutic intervention or where physical activity is specifically being evaluated and shared with patients. Patients on studies not evaluating or sharing physical activity are eligible for the present study if they meet the other inclusion/exclusion criteria and participation in the present study is not excluded by other studies in which they are enrolled.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Early Sharing Arm
early sharing of GA and OFS results to participants |
Early vs. delayed sharing of GA and OFS diagnostic results and how that sharing affects patient preferences, decision- making, and satisfaction in the context of participants' cancer care.
Outros nomes:
|
|
Sem intervenção: Delayed Sharing Arm
delayed sharing of GA and OFS results to participants |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Absolute change in QQ-Length of life from baseline to post-intervention
Prazo: From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
The QQ uses a 5-point Likert scale to rate each of the 4 questions on the QQ-L subscale. The scores for this subscale are then summed, meaning that patients will receive a score ranging from 4-20 for the QQ-L. The total score from the 4 QQ-L items measures the strength of a participant's preference for length of life, with higher scores meaning greater preference for length of life. |
From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The secondary outcome will be the absolute change in the QQ quality of life subscale (QQ-Q) from baseline to post-intervention.
Prazo: From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
The QQ uses a 5-point Likert scale to rate each of the 4 questions on the QQ-Q subscale. The scores for the subscale are then summed, meaning that patients will receive a score ranging from 4-20 for the QQ-Q. The total score from the 4 QQ-Q items measures the strength of a participant's preference for quality of life, with higher scores meaning greater preference for quality of life. |
From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The proportion of patients who, on the Was It Worth It (WIWI) questionnaire, report that their treatment was worthwhile, that they would undergo it again, and that they would recommend it to others.
Prazo: From enrollment to the end of treatment or at 3 months after study entry, whichever comes first.
|
The proportion of patients who, on the Was It Worth It (WIWI) questionnaire, report that their treatment was worthwhile, that they would undergo it again, and that they would recommend it to others. |
From enrollment to the end of treatment or at 3 months after study entry, whichever comes first.
|
|
Summary/descriptive statistics for participants' answers to the preferences questionnaire.
Prazo: From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
It inquires about their preferences for receipt, use and sharing of their assessment results, along with the degree to which receipt of these results affected their understanding or approach to their care |
From baseline questionnaire at enrollment to post intervention questionnaire at an average of 4 weeks after enrollment.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Zachary Frosch, MD, MSHP, Fox Chase Cancer Center
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
- Teste controlado e aleatório
- monitoramento de condicionamento físico
- Intervenção de prestação de cuidados
- Status funcional em idosos
- Preferências de tratamento do câncer
- Qualidade vs Quantidade de Vida
- Resultados relatados pelo paciente em oncologia
- Qualidade de vida no tratamento do câncer
- Avaliações funcionais de saúde
- Tratamento do câncer centrado no paciente
Termos MeSH relevantes adicionais
- Qualidade, acesso e avaliação da assistência médica
- Técnicas de investigação
- Métodos epidemiológicos
- Terapêutica
- Procedimentos cirúrgicos, operatórios
- Coleta de dados
- Mecanismos de avaliação de saúde
- Qualidade de assistência médica
- Saúde pública
- Meio ambiente e saúde pública
- Fenômenos fisiológicos
- Crescimento e desenvolvimento
- Técnicas cosméticas
- Pesquisas e questionários
- Envelhecimento
- Body Modification, Non-Therapeutic
Outros números de identificação do estudo
- 24-1020
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual Participant Data will not be shared due to privacy concerns.
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