- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03975621
Nurse AMIE: Addressing Metastatic Individuals Everyday (NurseAMIE)
Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Pennsylvania
-
Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Cancer Institute
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Women with metastatic breast cancer
- ECOG performance score ≤3.
- English Speaking
- With sufficient vision/hearing or family support
- Willingness to be randomized
Exclusion Criteria:
- Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
- Patients who are receiving any other behavioral intervention
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: Immediate Intervention
The immediate intervention group will receive the intervention at the time of consent (baseline) and will be enrolled in the intervention for a total of 6 months.
Patients will receive the tablet, a pedometer and an exercise band.
Patients will use Nurse AMIE while receiving weekly phone calls from a patient navigator.
After 90 days of the intervention observation will take place for 90 days, the patient will be asked to continue using Nurse AMIE without a patient navigator's presence.
|
Patient will receive the tablet, a pedometer (to track their steps) and an exercise band (to complete the exercise videos). Use of Nurse AMIE while receiving intervention phone calls from a patient navigator. After 90 days, observation begins and the patient will be asked to continue using Nurse AMIE without a patient navigator's presence. |
Experimental: Delayed Intervention
The delayed intervention group will receive the intervention 3 months after consent (6 months of intervention with 3 months delay total of 9 months); the patient will then follow the same pattern as listed above.
The only difference is we will ask the delayed intervention group to wear a FitBit device for 1 week following consent in order to gain baseline data as to their activity/movement.
|
Patient will receive the tablet, a pedometer (to track their steps) and an exercise band (to complete the exercise videos). Use of Nurse AMIE while receiving intervention phone calls from a patient navigator. After 90 days, observation begins and the patient will be asked to continue using Nurse AMIE without a patient navigator's presence. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Feasibility of the Application: The proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.
Prazo: 3 Months
|
Feasibility is defined as the proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.
|
3 Months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Acceptability of the Application: The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
Prazo: 3 Months
|
The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
|
3 Months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Quality of Life: Short Form 36
Prazo: Through study completion, an average of 9 months
|
The Short Form 36 Health Survey (SF-36) is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
Through study completion, an average of 9 months
|
Quality of Life: Functional Assessment of Cancer Therapy- Breast
Prazo: Through study completion, an average of 9 months
|
The Functional Assessment of Cancer Therapy-Breast (FACT-B), is a 44-item self-report instrument designed to measure multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B questionnaire includes 44 items, consisting of 5 subscales, all subscale items are summed to a total. The higher the score the better QOL |
Through study completion, an average of 9 months
|
Physical Function: Short Physical Performance Battery
Prazo: Through study completion, an average of 9 months
|
Objectively-measured physical function will be assessed using the Short Physical Performance Battery (SPPB).
The SPPB is an accumulation of balance tests, 4-meter gait speed, and 5-chair stands.
Based on the time needed to complete the chair stands, a score is given.
A summation of scores from all tests is taken, ranging from 0 -12.
A higher score = Higher physical function.
|
Through study completion, an average of 9 months
|
Sleep: Sleep Quality Assessment (PSQI)
Prazo: Through study completion, an average of 9 months
|
Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index (PSQI). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
Through study completion, an average of 9 months
|
Pain: Brief Pain Inventory (Short Form)
Prazo: Through study completion, an average of 9 months
|
Bodily pain will be assessed using the Brief Pain Inventory- Short form (BPI-SF). The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. |
Through study completion, an average of 9 months
|
Fatigue: Brief Fatigue Inventory
Prazo: Through study completion, an average of 9 months
|
The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue.
An increasing focus on cancer-related fatigue emphasized the need for sensitive tools to assess this most frequently reported symptom.
The six interference items correlate with standard quality-of-life measures.
|
Through study completion, an average of 9 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kathryn H Schmitz, PhD, Penn State University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- STUDY00011444
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Câncer de Mama Metastático
-
Turku University HospitalLounais-Suomen SyöpäyhdistysAinda não está recrutandoSobrevivente de cancerFinlândia
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RetiradoSobrevivente de cancerEstados Unidos
-
University of Alabama at BirminghamNational Cancer Institute (NCI); Auburn UniversityConcluído
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos, Guam
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); National Institute of Mental Health (NIMH)ConcluídoSobrevivente de cancerEstados Unidos
-
Masonic Cancer Center, University of MinnesotaConcluídoSobrevivente de cancerEstados Unidos
-
Abramson Cancer Center of the University of PennsylvaniaConcluídoPlano de cuidados de sobrevivência LIVESTRONG: coleta contínua de dados e pesquisa de acompanhamentoPaciente com cancerEstados Unidos
-
University of New MexicoNew Mexico State University; University of New Mexico Cancer CenterConcluído
-
Ohio State University Comprehensive Cancer CenterConcluídoSobrevivente de cancerEstados Unidos
Ensaios clínicos em Supportive Care
-
Silke Wiegand-Grefe, Prof. Dr.Charite University, Berlin, Germany; Hannover Medical School; University Hospital... e outros colaboradoresAtivo, não recrutando
-
Weill Medical College of Cornell UniversityCornell UniversityAinda não está recrutandoSobrecarga do cuidadorEstados Unidos
-
Barts & The London NHS TrustKing's College Hospital NHS TrustRetiradoDoenças Inflamatórias Intestinais
-
Elizabeth Glaser Pediatric AIDS FoundationUnited States Agency for International Development (USAID); Ministry of Health...ConcluídoInfecções por HIVSuazilândia
-
Institute of Mental Health, SingaporeNational Healthcare Group, SingaporeRecrutamentoDemência | Sobrecarga do cuidador | Saúde digitalCingapura
-
Northwestern UniversityBrown UniversityAtivo, não recrutando
-
US Department of Veterans AffairsConcluídoDiabetes | Doença de obstrução pulmonar crônica | Insuficiência Cardíaca CongestivaEstados Unidos
-
University Health Network, TorontoRecrutamentoLinfoma | Distúrbios Linfoproliferativos | Câncer de Mama Estágio I | Câncer de Mama Estágio II | Câncer Colorretal Estágio II | Câncer Colorretal Estágio III | Câncer de Mama Estágio III | Câncer Colorretal Estágio I | Câncer de Cabeça e Pescoço Estágio III | Câncer de Mama, Estágio 0 | Câncer de Cabeça e... e outras condiçõesCanadá
-
KintoAlzheimer's AssociationConcluídoDemência | Doença de Alzheimer | Doença de corpos de Lewy | Demência frontotemporal | Demencia vascular | Demência mistaEstados Unidos
-
Emory UniversityFoundation for Physical Therapy, Inc.ConcluídoDerrameEstados Unidos