Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients (Fit2ThriveMB)
The purpose of this study is to examine which of four components of a digital health intervention using an App and Fitbit meaningfully contribute to increased physical activity in Metastatic Breast Cancer Patients.
Participants will be asked to:
- Wear a Fitbit and use an app, use 0 to 3 other components for 24 weeks and attend 6 or 12 coaching coaching calls in the first 12 weeks to increase daily steps.
- Complete a questionnaire at baseline, week 12 and week 24
- Complete functional performance test (FPT) via Zoom at baseline, week 12 and week 24
- Wear a research activity monitor (Accelerometer) for 7 days at baseline, week 12 and week 24
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Multiphase Optimization Strategy (MOST) methodology will be used to determine which intervention components or component combinations optimally increase daily steps in a 12-week intervention with a 12-week follow-up. MOST is a framework adapted from engineering that uses highly efficient factorial experiments to evaluate individual, and combined, effects of intervention components to determine which ones can be reduced, eliminated, or replaced to improve efficiency. Insufficiently active people with metastatic breast cancer (MBC) will receive a core intervention consisting of the FIt2ThriveMB app and Fitbit and be randomly assigned to four components, each with two-levels, under consideration for inclusion in the optimized intervention: 1) EHR-integration (on v. off); 2) coaching dose (weekly v. bi-weekly; 3) social+ (on v. off) and 4) goal-setting type (highly tailored v. static). The effects of increasing PA on symptom burden, other intensity activities (i.e. moderate to vigorous, light and sedentary), and functional performance and potential mediators and moderators of component effects will also be examined. Knowledge gained from this study will inform the development of more effective and scalable interventions to improve health and disease outcomes in this population.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Siobhan Phillips, PhD
- Número de telefone: 312-503-4235
- E-mail: smphillips@northwestern.edu
Locais de estudo
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Contato:
- Siobhan Phillips, PhD
- Número de telefone: 312-503-4235
- E-mail: smphillips@northwestern.edu
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-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Female sex assigned at birth, age 18 years or older
- Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection.
- Self-report engagement in <150 min/week of moderate to vigorous physical activity
- Ownership of an Android or iPhone with an up-to-date version of the operating system
- Internet access to complete assessments
- Fluency in spoken and written English
- Willingness to obtain medical clearance to participate.
Exclusion Criteria:
- Untreated brain metastases
- Breast cancer with metastases to only the axillary lymph nodes.
- Self-reported absolute contraindications to exercise (i.e., non-ambulatory, acute myocardial infarction, severe cognitive or functional impairment)
- Currently pregnant or plans to become pregnant
- Plans to move out of the United States in next 12 months
- Current enrollment in another dietary or physical activity trial
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Solteiro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Experimental: 1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants. Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day. |
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Experimental: 2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients. Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants. Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. |
|
Experimental: 3- Core, EHR, Weekly Coaching, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.). |
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Experimental: 4- Core, EHR, Bi-Weekly Coaching, Static Goal Setting
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The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.). |
|
Experimental: 5- Core, EHR, Weekly Coaching, Social+, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants. Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.). |
|
Experimental: 6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients. Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.). |
|
Experimental: 7- Core, EHR, Weekly Coaching, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day. |
|
Experimental: 8- Core, EHR, Bi-Weekly Coaching, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participant Fitbit data will synchronize with the EHR. Participants will receive automated weekly messages via the patient portal. Clinicians can view patient Fitbit data and will receive Epic InBasket messages on the day of patient appointments with a summary of patients' PA progress and talking points to encourage patients. Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. |
|
Experimental: 9- Core, Weekly Coaching, Social+, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants. Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.). |
|
Experimental: 10- Core, Bi-Weekly Coaching, Social+, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.). |
|
Experimental: 11- Core, Weekly Coaching, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day. |
|
Experimental: 12- Core, Bi-Weekly Coaching, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. |
|
Experimental: 13- Core, Weekly Coaching, Social+, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants. Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day. |
|
Experimental: 14- Core, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants assigned to this condition will receive the social feed app module and attend 7 synchronous, facilitated group sessions during the 12-week intervention. There will also be a social feed app module is intended to enhance communication and support among participants. Participants will be prompted each morning to report the intensity of their symptom burden on a scale from 1 to 5. Based on symptom rating, prior day's step goal attainment and/or the number of steps achieved the previous day, participants will be provided with three to four goal options for that day. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. |
|
Experimental: 15- Core, Weekly Coaching, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants will receive 12 calls from study staff to provide feedback on PA progress and support to increase PA. Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.). |
|
Experimental: 16- Core, Bi-Weekly Coaching, Static Goal Setting
|
The core intervention includes educational materials, Fitbit and access to the Fit2ThriveMB Core App. Participants will receive 6 calls from study staff to provide feedback on PA progress and support to increase PA. Participants will be provided with a daily step goal for the week. The goal will be progressive and tailored to each individual's progress to build efficacy and ensure safe progression until 10,000 steps/day is achieved (i.e. 4500 steps/day in week 1, 5500 steps/day in week 2, etc.). |
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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Change in Steps
Prazo: Baseline, 12 and 24 weeks
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The ActiGraph accelerometer will be used. Participants will wear the device during all waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip. |
Baseline, 12 and 24 weeks
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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ActiGraph measured MVPA
Prazo: Baseline, 12 and 24 weeks
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Moderate to vigorous physical activity will be measured using the ActiGraph. Participants will wear the device during waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip. Freedson cut points will be used to determine this activity as 2,690-9,642 CPM. |
Baseline, 12 and 24 weeks
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ActiGraph measured light activity
Prazo: Baseline, 12 and 24 weeks
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Light intensity physical activity will be measured using the ActiGraph. I Participants will wear the device during waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip. Freedson cutpoints for light activity are defined as Light: 0 - 2,689 CPM. |
Baseline, 12 and 24 weeks
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ActiGraph measured sedentary behavior
Prazo: Baseline, 12 and 24 weeks
|
Sedentary behavior will be measured using the ActiGraph. Participants will wear the device during waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip. Freedson cutpoints for sedentary behavior are defined as <100 CPM. |
Baseline, 12 and 24 weeks
|
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Godin Leisure Time Exercise Questionnaire
Prazo: Baseline, 12 and 24 weeks
|
Participants will be asked to indicate frequency of participation in strenuous (e.g., jogging), moderate (e.g., fast walking), and mild (e.g., easy walking) exercise over the past 7 days and average time spent in each activity. Activity frequencies will be multiplied by 9, 5, and 3 metabolic equivalents, respectively, and summed to create a total leisure time activity score. Weekly minutes of total, light, moderate, and vigorous activity will be calculated by multiplying the frequency and time of each activity. This value will be divided by 7 to obtain daily averages. |
Baseline, 12 and 24 weeks
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Short Physical Performance Battery (SPPB) Total Score
Prazo: Baseline, 12 weeks, 24 weeks
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The SPPB score is based on timed measures of gait speed, ability to rise from a chair, and standing balance. Gait speed will be measured using the better of two recorded times over a 4-meter course. Chair stand time will be measured as the time needed to rise five times from a seated position in a chair, with arms folded across the chest. For the balance test, participants will be asked to maintain their feet side-by-side, semi-tandem, and tandem positions for 10 seconds each. Each individual performance measure will be scored according to established cut points and aggregated for a total SPPB score. |
Baseline, 12 weeks, 24 weeks
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PROMIS Physical Function
Prazo: Baseline, 12 and 24 weeks
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PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure physical function with 4 items over the past 7 days. Items are combined using a t-score metric where higher score is better. |
Baseline, 12 and 24 weeks
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PROMIS Anxiety
Prazo: Baseline, 12 and 24 weeks
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PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Anxiety with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better. |
Baseline, 12 and 24 weeks
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PROMIS Depression
Prazo: Baseline, 12 and 24 weeks
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PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Depression with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better. |
Baseline, 12 and 24 weeks
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PROMIS Fatigue
Prazo: Baseline, 12 and 24 weeks
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PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Fatigue with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better. |
Baseline, 12 and 24 weeks
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PROMIS Ability to Participate in Social Roles and Activities
Prazo: Baseline, 12 and 24 weeks
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PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure Ability to Participate in Social Roles and Activities with 4 items over the past 7 days. Items are combined using a t-score metric where the higher score is better. |
Baseline, 12 and 24 weeks
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PROMIS Sleep Disturbance
Prazo: Baseline, 12 and 24 weeks
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PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure sleep disturbance with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better. |
Baseline, 12 and 24 weeks
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PROMIS Pain Interference
Prazo: Baseline, 12 and 24 weeks
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PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure pain interference with 4 items over the past 7 days. Items are combined using a t-score metric where the lower score is better. |
Baseline, 12 and 24 weeks
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PROMIS Pain Intensity
Prazo: Baseline, 12 and 24 weeks
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PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-item Profile) will be used to measure pain intensity with 1 item using a scale 1-10 over the past 7 days. Items are combined using a t-score metric where the lower score is better. |
Baseline, 12 and 24 weeks
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- STU00224173
- R01CA305818 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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