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Rehabilitation After Breast Cancer (REBECCA II)

26 de agosto de 2021 atualizado por: Christoffer Johansen, Danish Cancer Society

Individually Tailored Rehabilitation After Breast Cancer

The aim of the study is to evaluate whether a screening-based individually tailored nurse navigator intervention compared to standard care significantly reduce psychological and physical symptoms among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter the randomized controlled trial (RCT) and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.

Tipo de estudo

Intervencional

Inscrição (Real)

309

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

  • Dinamarca
      • Copenhagen, Dinamarca, DK-2100
        • Rigshospitalet

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:

  • Newly diagnosed with breast cancer (i.e. prior to surgery), scheduled for breast cancer surgery at Section of Breast Surgery at Rigshospitalet, 18 years or above, Danish citizen, read, understand and speak Danish, female gender,signed written informed consent. Those who experience high psychological distress (score ≥ 7 on the distress thermometer) will enter the RCT whereas those who experience low psychological distress (score < 7 on the distress thermometer) will be followed in an observational questionnaire study.

Exclusion Criteria:

  • no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,

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

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Ao controle
Cuidados usuais
Experimental: Intervention
Individually tailored nurse navigation
Comportamental: Individually tailored nurse navigation
The intervention consists of systematic report of symptoms to the nurse and up to six individual, manual-based, face-to-face or telephone nurse navigator sessions depending on individual needs.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Distress
Prazo: Change from baseline and to 6,12 months (mixed models)
Distress Thermometer
Change from baseline and to 6,12 months (mixed models)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Distress
Prazo: Change from baseline to 6 months
Distress Thermometer
Change from baseline to 6 months
Distress
Prazo: Change from baseline to 12 months
Distress Thermometer
Change from baseline to 12 months
Distress
Prazo: Change from baseline to 18 months
Distress Thermometer
Change from baseline to 18 months
Depression
Prazo: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
The Patient Health Questionnaire (PHQ9)
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Depression
Prazo: Change from baseline and to 6 months
The Patient Health Questionnaire (PHQ9)
Change from baseline and to 6 months
Depression
Prazo: Change from baseline and to 12 months
The Patient Health Questionnaire (PHQ9)
Change from baseline and to 12 months
Depression
Prazo: Change from baseline and to 18 months
The Patient Health Questionnaire (PHQ9)
Change from baseline and to 18 months
Anxiety
Prazo: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Generalized Anxiety Disorder (GAD7)
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Anxiety
Prazo: Change from baseline and to 6 months
Generalized Anxiety Disorder (GAD7)
Change from baseline and to 6 months
Anxiety
Prazo: Change from baseline and to 12 months
Generalized Anxiety Disorder (GAD7)
Change from baseline and to 12 months
Anxiety
Prazo: Change from baseline and to 18 months
Generalized Anxiety Disorder (GAD7)
Change from baseline and to 18 months
Health related quality of life summary index
Prazo: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)

The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:

  • Physical well-being (PWB)
  • Functional wellbeing (FWB)
  • BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Health related quality of life summary index
Prazo: Change from baseline and to 6 months

The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:

  • Physical well-being (PWB)
  • Functional wellbeing (FWB)
  • BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 6 months
Health related quality of life summary index
Prazo: Change from baseline and to 12 months

The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:

  • Physical well-being (PWB)
  • Functional wellbeing (FWB)
  • BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 12 months
Health related quality of life summary index
Prazo: Change from baseline and to 18 months

The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:

  • Physical well-being (PWB)
  • Functional wellbeing (FWB)
  • BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 18 months
Breast cancer related quality of life summary index
Prazo: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Breast cancer related quality of life summary index
Prazo: Change from baseline and to 6 months
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 6 months
Breast cancer related quality of life summary index
Prazo: Change from baseline and to 12 months
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 12 months
Breast cancer related quality of life summary index
Prazo: Change from baseline and to 18 months
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 18 months
Functional related quality of life summary index
Prazo: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Functional related quality of life summary index
Prazo: Change from baseline and to 6 months
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 6 months
Functional related quality of life summary index
Prazo: Change from baseline and to 12 months
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 12 months
Functional related quality of life summary index
Prazo: Change from baseline and to 18 months
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 18 months
Physical health related quality of life
Prazo: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Physical health related quality of life
Prazo: Change from baseline and to 6 months
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 6 months
Physical health related quality of life
Prazo: Change from baseline and to 12 months
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 12 months
Physical health related quality of life
Prazo: Change from baseline and to 18 months
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 18 months
Social health related quality of life
Prazo: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Social health related quality of life
Prazo: Change from baseline and to 6 months
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 6 months
Social health related quality of life
Prazo: Change from baseline and to 12 months
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 12 months
Social health related quality of life
Prazo: Change from baseline and to 18 months
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 18 months
Emotional health related quality of life
Prazo: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
Emotional health related quality of life
Prazo: Change from baseline and to 6 months
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 6 months
Emotional health related quality of life
Prazo: Change from baseline and to 12 months
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 12 months
Emotional health related quality of life
Prazo: Change from baseline and to 18 months
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
Change from baseline and to 18 months
Self-efficacy
Prazo: Change from baseline and to 6,12,18 months (mixed models)
Patient Activation Measure (PAM)
Change from baseline and to 6,12,18 months (mixed models)
Self-efficacy
Prazo: Change from baseline and to 6 months
Patient Activation Measure (PAM)
Change from baseline and to 6 months
Self-efficacy
Prazo: Change from baseline and to 12 months
Patient Activation Measure (PAM)
Change from baseline and to 12 months
Self-efficacy
Prazo: Change from baseline and to 18 months
Patient Activation Measure (PAM)
Change from baseline and to 18 months
Fear of recurrence
Prazo: 6 months
Concerns About Recurrence Questionnaire (CARQ)
6 months
Fear of recurrence
Prazo: 12 months
Concerns About Recurrence Questionnaire (CARQ)
12 months
Fear of recurrence
Prazo: 18 months
Concerns About Recurrence Questionnaire (CARQ)
18 months
Pain in the breast surgery area (side of chest, armpit or arm)
Prazo: Change from baseline and to 6,12,18 months (mixed models)
Self-developed scale
Change from baseline and to 6,12,18 months (mixed models)
Pain in the breast surgery area (side of chest, armpit or arm)
Prazo: Change from baseline and to 6 months
Self-developed scale
Change from baseline and to 6 months
Pain in the breast surgery area (side of chest, armpit or arm)
Prazo: Change from baseline and to 12 months
Self-developed scale
Change from baseline and to 12 months
Pain in the breast surgery area (side of chest, armpit or arm)
Prazo: Change from baseline and to 18 months
Self-developed scale
Change from baseline and to 18 months
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Prazo: Change from baseline and to 6,12,18 months (mixed models)
Self-developed scale
Change from baseline and to 6,12,18 months (mixed models)
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Prazo: Change from baseline and to 6 months
Self-developed scale
Change from baseline and to 6 months
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Prazo: Change from baseline and to 12 months
Self-developed scale
Change from baseline and to 12 months
Neuropathy in the breast surgery area (side of chest, armpit or arm)
Prazo: Change from baseline and to 18 months
Self-developed scale
Change from baseline and to 18 months
Sleep quality
Prazo: Change from baseline and to 6,12,18 months (mixed models)
Pittsburgh Sleep Quality Index (PSQI)
Change from baseline and to 6,12,18 months (mixed models)
Sleep quality
Prazo: Change from baseline and to 6 months
Pittsburgh Sleep Quality Index (PSQI)
Change from baseline and to 6 months
Sleep quality
Prazo: Change from baseline and to 12 months
Pittsburgh Sleep Quality Index (PSQI)
Change from baseline and to 12 months
Sleep quality
Prazo: Change from baseline and to 18 months
Pittsburgh Sleep Quality Index (PSQI)
Change from baseline and to 18 months
Cognitive function - Perceived cognitive impairments
Prazo: Change from baseline and to 6,12,18 months (mixed models)
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Change from baseline and to 6,12,18 months (mixed models)
Cognitive function - Perceived cognitive impairments
Prazo: Change from baseline and to 6 months
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Change from baseline and to 6 months
Cognitive function- Perceived cognitive impairments
Prazo: Change from baseline and to 12 months
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Change from baseline and to 12 months
Cognitive function - Perceived cognitive impairments
Prazo: Change from baseline and to 18 months
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
Change from baseline and to 18 months
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Prazo: Change from baseline and to 6,12,18 months (mixed models)
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
Change from baseline and to 6,12,18 months (mixed models)
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Prazo: Change from baseline and to 6 months
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
Change from baseline and to 6 months
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Prazo: Change from baseline and to 12 months
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
Change from baseline and to 12 months
Cognitive function - Impact of Perceived cognitive impairments on quality of life
Prazo: Change from baseline and to 18 months
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
Change from baseline and to 18 months
Cognitive function - Perceived cognitive abilities
Prazo: Change from baseline and to 6,12,18 months (mixed models)
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Change from baseline and to 6,12,18 months (mixed models)
Cognitive function - Perceived cognitive abilities
Prazo: Change from baseline and to 6 months
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Change from baseline and to 6 months
Cognitive function - Perceived cognitive abilities
Prazo: Change from baseline and to 12 months
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Change from baseline and to 12 months
Cognitive function - Perceived cognitive abilities
Prazo: Change from baseline and to 18 months
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
Change from baseline and to 18 months
Need for support
Prazo: Change from baseline and to 6,12,18 months (mixed models)
Single self-developed items
Change from baseline and to 6,12,18 months (mixed models)
Need for support
Prazo: Change from baseline and to 6 months
Single self-developed items
Change from baseline and to 6 months
Need for support
Prazo: Change from baseline and to 12 months
Single self-developed items
Change from baseline and to 12 months
Need for support
Prazo: Change from baseline and to 18 months
Single self-developed items
Change from baseline and to 18 months
Health care costs
Prazo: Cumulative from baseline to 18 months
Costs will be obtained through registries on health care services and combined with information on health status using the 5Q-5D from the EuroQol Research Foundation's
Cumulative from baseline to 18 months
Acceptability
Prazo: 18 months
Single self-developed items
18 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Social support
Prazo: Baseline
Modified Medical Outcomes Study Social Support Scale (MOS)
Baseline

Colaboradores e Investigadores

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

Patrocinador

Danish Cancer Society

Colaboradores

Rigshospitalet, Denmark
Copenhagen University Hospital at Herlev

Investigadores

  • Investigador principal: Pernille Bidstrup, PhD, Danish Cancer Society Research Center
  • Investigador principal: Christoffer Johansen, DMSc, Rigshispitalet
  • Cadeira de estudo: Birgitte Mertz, RN, Rigshospitalet, Denmark

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)

15 de agosto de 2017

Conclusão Primária (Real)

31 de março de 2021

Conclusão do estudo (Real)

31 de março de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

31 de julho de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de agosto de 2017

Primeira postagem (Real)

21 de agosto de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de agosto de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de agosto de 2021

Última verificação

1 de agosto de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • REBECCA II

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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