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Nurse AMIE: Addressing Metastatic Individuals Everyday (NurseAMIE)

19 de janeiro de 2022 atualizado por: Kathryn Schmitz, Milton S. Hershey Medical Center

Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)

Determine the acceptability and feasibility of a supportive care software platform to improve quality of life and function in metastatic breast cancer patients. Acceptability will be defined as the proportion of women offered the intervention who agree to participate. Feasibility will be 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.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

Goals of the Nurse AMIE software program are to regularly assess psychosocial, functional, and symptom needs among metastatic breast cancer patients and to provide appropriate interventions via YouTube style videos, weekly phone calls with a patient navigator at Penn State, and appropriate referrals to phone or in person consultations as needed. The proposed Nurse AMIE software program will allow for the provision of resources (YouTube style videos, audio files, exercises) to intervene on many of the common symptoms and challenges experienced by metastatic patients. This is an identified need on the part of both metastatic patients and their medical care teams. Finally, it will also allow patient navigators to check in with patients, reviewing responses to surveys, discerning whether new or different interventions are needed, and connecting women to palliative care and other services if additional care is warranted.

Tipo de estudo

Intervencional

Inscrição (Real)

21

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Penn State Cancer Institute

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Kathryn H Schmitz, PhD, Penn State University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de março de 2019

Conclusão Primária (Real)

1 de setembro de 2020

Conclusão do estudo (Real)

1 de setembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

4 de junho de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2019

Primeira postagem (Real)

5 de junho de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de janeiro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de janeiro de 2022

Última verificação

1 de janeiro de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • STUDY00011444

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

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