Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB
17 de outubro de 2022 atualizado por: Siobhan M Phillips, Northwestern University
This study will test the feasibility and acceptability of increasing PA in metastatic breast cancer (MBC) patients using a smartphone app, fitbit and coaching.
Visão geral do estudo
Status
Status
Concluído
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
The primary purpose of the present study is to pilot test the feasibility and acceptability of a 12 week mHealth intervention to increase PA in metastatic breast cancer (MBC) patients using a two-arm randomized control trial (RCT).
We will also examine the effects of the intervention on symptom burden, quality of life, and functional performance.
Inactive MBC patients will be assigned to Fit2ThriveMB or education control.
Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls.
Participants in the education control will be asked to download the app cancer.net
from the American Society of Clinical Oncology, will receive educational materials and calls during the intervention period and the Fitbit following completion of 12 week assessments.
Tipo de estudo
Tipo de estudo
Intervencional
Inscrição (Real)
Inscrição
49
Estágio
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
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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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
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:
- Female; ≥18 years of age
- Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection (Metastases to the auxiliary lymph nodes, and nowhere else in the body, do not qualify).
- Fluent in spoken and written English
- Own a smartphone
- Have access to the internet to complete assessments
- Self-report engaging in <150 minutes of moderate to vigorous PA per week.
Exclusion Criteria:
- Untreated brain metastases
- Uncontrolled cardiovascular disease or other major contraindications (i.e. non- ambulatory, severe cognitive or functional limitations) to PA participation
- Current enrollment in another dietary or PA trial
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: Solteiro
Número de braços
2
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Experimental: Fit2ThriveMB
Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls.
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The Fit2thriveMB app will encourage participants to increase their physical activity.
Participants will be provided with educational information on physical activity and effective behavior change strategies for incorporating more physical activity into their daily lives to increase their step count.
Participants will be prompted each morning to report the intensity of their symptom burden (0 to 10).
Based on their symptom rating and their previous day's step counts, participants will be provided with three different options or levels of goals for that day to either increase or decrease 10-20% or remain constant.
The Fitbit measures PA intensity, steps, and heart rate and syncs directly with the smartphone and will automatically sync with the Fit2ThriveMB app and provide Fitbit data to the study team in real-time.
Participants will receive weekly coaching calls which will: a) provide feedback on the previous week's symptom burden and progress on PA goals; b) review personalized goals and strategies for increasing PA for the next week; c) provide instruction on effective behavioral change techniques
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Comparador Ativo: Healthy Living Control
Participants in the healthy living group will receive the American Society of Cancer Oncologists smartphone app, cancer.net.
They will also receive calls during the intervention period and the Fitbit following completion of 12 week assessments
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Participants will receive weekly calls that will cover health and well-being topics for instance: symptom and stress management, healthy diet, hydration, sun safety, sleep hygiene, and meditation.
Cancer.net app content includes information about health and well-being, treatment guidelines specific to cancer type, symptom tracking and medication tracking
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period
Prazo: 12 weeks
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Feasibility will be assessed via participant retention during the intervention period [(# of participants randomized- # of participants who drop out or are lost to follow-up)/ # randomized].
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12 weeks
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Adherence to a 12 Week Technology Supported Physical Activity Intervention by Metastatic Breast Cancer Patients
Prazo: 12 weeks
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Adherence during the 12 week intervention will be monitored continuously using Fit2ThriveMB app.
This measure the average percentage of days each participant in the Fit2ThriveMB intervention group wore the Fitbit.
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12 weeks
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Acceptability of a 12 Week Technology Supported Physical Activity Intervention to Metastatic Breast Cancer Patients
Prazo: 12 weeks
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Acceptability will be measured via a process evaluation of perceptions of MBC patients' experiences with Fit2ThriveMB.
Acceptability will be measured as the number of intervention participants who are satisfied/very satisfied with their overall study experience.
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12 weeks
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Physical Activity Minutes From Before to After a 12 Week Technology Supported Physical Activity Intervention in Metastatic Breast Cancer Patients
Prazo: Baseline and 12 weeks
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Physical activity will be measured at baseline and at 12 weeks.
The change between physical activity at baseline and 12-weeks will be assessed.
The ActiGraph accelerometer will be used.
At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming.
Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
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Baseline and 12 weeks
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Change in Quality of Life From From Baseline to 12-weeks
Prazo: Baseline and 12 weeks
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Quality of life will be measured at baseline and 12 weeks using the Functional Assessment of Cancer Therapy-Breast (FACT-B).
Totals scores range from 0 to 148.
Higher scores indicate better quality of life.
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Baseline and 12 weeks
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Change in Anxiety From Baseline to 12-weeks
Prazo: Baseline and 12 weeks
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Anxiety will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a health measure.
T-scores range from 37.1 to 83.1.
Higher scores indicate more anxiety.
T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
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Baseline and 12 weeks
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Change in Depression From Baseline to 12-weeks
Prazo: Baseline and 12 weeks
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Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure.
T-scores range from 38.2 to 81.3.
Higher scores indicate more depression.
T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
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Baseline and 12 weeks
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Change in Fatigue From Baseline to 12-weeks
Prazo: Baseline and 12 weeks
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Fatigue will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure.
T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue.
T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
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Baseline and 12 weeks
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Change in Pain Interference From Baseline to 12-weeks
Prazo: Baseline and 12 weeks
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Pain Interference will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Interference 8a health measure.
T-scores range from 40.7 to 77.0 Higher scores indicate more pain interference.
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Baseline and 12 weeks
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Change in Physical Function From Baseline to 12-weeks
Prazo: Baseline and 12 weeks
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Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure.
T-scores range from 32.7 to 62.7.
Higher scores indicate better physical functioning.
T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
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Baseline and 12 weeks
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Change in Sleep Disturbance From Baseline to 12-weeks
Prazo: Baseline and 12 weeks
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Sleep disturbance will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-sleep disturbance 8a health measure.
T-scores range from 30.5 to 77.5.
Higher scores more sleep disturbance.
T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
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Baseline and 12 weeks
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Change in Short Physical Performance Battery (SPPB) Scores From Baseline to 12 Weeks
Prazo: Baseline and 12 weeks
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Participants will complete the Short Physical Performance Battery which includes assessments of gait speed, chair stands and standing balance that are combined to obtain a SPPB score.
This test will be conducted at baseline and 12 weeks.
SPPB scores range from 0 to 12. Higher scores mean better physical functioning.
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Baseline and 12 weeks
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Change in Arm Curl Test and Two-Minute Step Test From the Senior Fitness Test Measures Between Baseline and 12 Weeks
Prazo: Baseline and 12 weeks
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The Senior Fitness Test measures physical function.
The arm curl test assesses the number of times (repetitions) a 5lb hand-weight is curled in 30 seconds.
The 2-minute step test evaluates the number of times (repetitions) the right knee reaches a distance half way between the iliac crest and patella during 2-minutes.
Increased number of repetitions on both tests represents better physical function.
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Baseline and 12 weeks
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Change in 6-minute Walk Test Distance Between Baseline and 12-weeks.
Prazo: Baseline and 12 weeks
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Participants will complete a 6 minute walk test at baseline and 12 weeks.
Distance is measured in meters.
Increases in distance represent better performance.
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Baseline and 12 weeks
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Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between Baseline and 12 Weeks
Prazo: Baseline and 12 weeks
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The Senior Fitness Test measures physical function.
The one leg stand test assesses how long an individual can stand on each of their feet (right and left) in seconds up to 30-seconds.
Increases in time on the one leg stand tests indicate better functioning.
The 8-foot up and go test assesses how long it takes in seconds to stand from a chair, walk 8 feet around an object and return to sitting.
Decreases in time indicate better functioning.
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Baseline and 12 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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Colaboradores
Colaboradores
Publicações e links úteis
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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)
Início do estudo
26 de novembro de 2019
Conclusão Primária (Real)
Conclusão Primária
1 de maio de 2021
Conclusão do estudo (Real)
Conclusão do estudo
1 de maio de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
11 de outubro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de outubro de 2019
Primeira postagem (Real)
Primeira postagem
16 de outubro de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
10 de novembro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de outubro de 2022
Última verificação
Última verificação
1 de outubro de 2022
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- SP00049673
- R21CA239130 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy.
We welcome inquiries by investigators who are not associated with the study to review or analyze data that we have collected.
All requests for data sharing will be handled by the PI, Dr. Phillips, in conjunction with co-investigators, on a case by case basis to ensure that the proposed work does not conflict with planned analyses; we will also establish that the proposed project has sufficient scientific merit before proceeding.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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 .