Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on QoL in Breast Cancer Survivors
22 de setembro de 2020 atualizado por: Karis Cheng, National University of Singapore
Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on Quality of Life in Breast Cancer Survivors
Breast cancer is the most common cancer in women in Singapore.
Breast cancer survivors usually experience side effects/symptoms after surgery and/or adjuvant chemotherapy and/or radiotherapy such as fatigue, lymphedema, problems with sleeping, peripheral neuropathy, and anxiety/depression.
Currently, there is no study to include both symptom management and mindfulness training components for breast cancer survivors.
And given breast cancer survivors have infrequent clinical follow-up, we aim to develop an e-Home based symptom management and mindfulness training programme for breast cancer survivors and to determine its effects on quality of life, symptom distress, psychosocial adjustment, psychological morbidity, and unplanned outpatient attendance or hospitalisation in breast cancer survivors.
We employ a randomised clinical trial with four study arms (with 47 subjects in each arm) together with a process evaluation; group 1 (usual care), group 2 (experimental group: five weekly sessions of online symptom management + mindfulness training programme and usual care), group 3 (comparison group 1: five weekly sessions of online symptom management programme and usual care), and group 4 (comparison group 2: five weekly sessions of online mindfulness training programme and usual care).
Subjects will complete questionnaires measures of 6-item Social Support Questionnaire, Breast Cancer Survivor Self-Efficacy Scale, the Quality of Life-Cancer Survivor Scale, Memorial Symptom Assessment Scale, Psychosocial Adjustment to Illness Scale, short version of the Fear of Recurrence Scale, Hospital and anxiety Depression Scale and Five Facet Mindfulness Questionnaire at baseline (printed questionnaires), at 8 weeks from baseline, at 12 weeks from baseline and at 24 weeks from baseline by an online system or printed questionnaires.
Individualised semi-structured interview (15-25 mins) for experimental and comparison groups will be conducted at 24 weeks from baseline to understand the subjects' experiences of the study programme.
Data will be analysed using SPSS version 24.
Baseline demographic and clinical information of subjects in the experimental, comparison and control groups will be summarised using descriptive statistics, and will be compared using chi square tests and ANOVA/ANCOVA tests.
Intention-to-treat approach will be used.
Repeated measures analysis of variance will be used to examine the differences on outcome measures among the experimental, comparison and control groups across study time points.
In addition, differences in changes in outcome measures among experimental, comparison groups and usual care groups will be tested using multilevel modelling techniques.
A p-value smaller than 5% will be considered as statistically significant.
Content analysis will be conducted to analyse the interviews data.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
172
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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Singapore, Cingapura
- National University Hospital
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Singapore, Cingapura
- National Cancer Centre Singapore
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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
Idades elegíveis para estudo
21 anos a 100 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- women aged 21 or above
- able to speak and read English
- diagnosed with breast cancer stage 0 to 3 for the first time
- have completed cancer treatment including breast surgery and/or adjuvant chemotherapy and/or radiotherapy between 6 months to 5 years previously
- with and without ongoing HER2 target therapy (e.g.: Herceptin) and/or hormonal therapy
- with ECOG Performance Status score of 0 to 1
- able to understand the study and give informed consent
- have access to the internet through a handheld device
Exclusion Criteria:
- they are illiterate
- have serious psychiatric disorders (e.g. schizophrenia, dementia, and intellectual disabilities)
- with ECOG Performance Status score of 2 or above
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 |
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Sem intervenção: Usual care group
Usual care is meant the routine medical and health care services at the hospital.
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Experimental: Experimental group
Five weekly sessions of online symptom management + mindfulness training programme + usual care
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5 weekly sessions of online self-administered mindfulness training programme in which they will receive audio-recorded and video-recorded instructions, pictorial or text-based instructions for various mindfulness exercises such as body scan meditation, mindful breathing and walking meditation.
5 weekly online education module in which they will receive video-recorded, audio-recorded, pictorial or text-based instructions for various self-management strategies.
Topics include fatigue, pain, numbness/tingling, lymphedema, anxiety/depression, and problems with sleeping.
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Comparador Ativo: Comparison group 1
Five weekly sessions of online symptom management programme + usual care
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5 weekly online education module in which they will receive video-recorded, audio-recorded, pictorial or text-based instructions for various self-management strategies.
Topics include fatigue, pain, numbness/tingling, lymphedema, anxiety/depression, and problems with sleeping.
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Comparador Ativo: Comparison group 2
Five weekly sessions of online mindfulness training programme and usual care
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5 weekly sessions of online self-administered mindfulness training programme in which they will receive audio-recorded and video-recorded instructions, pictorial or text-based instructions for various mindfulness exercises such as body scan meditation, mindful breathing and walking meditation.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Change from baseline quality of life score at 8 weeks
Prazo: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline quality of life score at 12 weeks
Prazo: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline quality of life score at 24 weeks
Prazo: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Change from baseline social support score at 8 weeks
Prazo: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline social support score at 12 weeks
Prazo: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline social support score at 24 weeks
Prazo: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline self-efficacy score at 8 weeks
Prazo: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline self-efficacy score at 12 weeks
Prazo: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline self-efficacy score at 24 weeks
Prazo: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline symptom score at 8 weeks
Prazo: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline symptom score at 12 weeks
Prazo: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline symptom score at 24 weeks
Prazo: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline psychosocial adjustment to illness score at 8 weeks
Prazo: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline psychosocial adjustment to illness score at 12 weeks
Prazo: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline psychosocial adjustment to illness score at 24 weeks
Prazo: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline fear of recurrence score at 8 weeks
Prazo: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline fear of recurrence score at 12 weeks
Prazo: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline fear of recurrence score at 24 weeks
Prazo: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline anxiety and depression score at 8 weeks
Prazo: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline anxiety and depression score at 12 weeks
Prazo: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline anxiety and depression score at 24 weeks
Prazo: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline mindfulness score at 8 weeks
Prazo: Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline mindfulness score at 12 weeks
Prazo: Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline mindfulness score at 24 weeks
Prazo: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Karis Cheng, National University of Singapore
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.
- Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
- Bower JE, Ganz PA, Desmond KA, Bernaards C, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in long-term breast carcinoma survivors: a longitudinal investigation. Cancer. 2006 Feb 15;106(4):751-8. doi: 10.1002/cncr.21671.
- Champion VL, Ziner KW, Monahan PO, Stump TE, Cella D, Smith LG, Bell CJ, Von Ah D, Sledge GW. Development and psychometric testing of a breast cancer survivor self-efficacy scale. Oncol Nurs Forum. 2013 Nov;40(6):E403-10. doi: 10.1188/13.ONF.E403-E410.
- Ferrell BR, Dow KH, Grant M. Measurement of the quality of life in cancer survivors. Qual Life Res. 1995 Dec;4(6):523-31. doi: 10.1007/BF00634747.
- Cheng KK, Darshini Devi R, Wong WH, Koh C. Perceived symptoms and the supportive care needs of breast cancer survivors six months to five years post-treatment period. Eur J Oncol Nurs. 2014 Feb;18(1):3-9. doi: 10.1016/j.ejon.2013.10.005. Epub 2013 Dec 5.
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)
6 de dezembro de 2016
Conclusão Primária (Real)
14 de março de 2020
Conclusão do estudo (Real)
14 de março de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
10 de outubro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de outubro de 2016
Primeira postagem (Estimativa)
13 de outubro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de setembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de setembro de 2020
Última verificação
1 de setembro de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R-545-000-073-592
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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