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Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on QoL in Breast Cancer Survivors

22 de septiembre de 2020 actualizado 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

172

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Singapore, Singapur
        • National University Hospital
      • Singapore, Singapur
        • National Cancer Centre Singapore

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años a 100 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Usual care group
Usual care is meant the routine medical and health care services at the hospital.
Experimental: Experimental group
Five weekly sessions of online symptom management + mindfulness training programme + usual care
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.
Comparador activo: Comparison group 1
Five weekly sessions of online symptom management programme + usual care
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.
Comparador activo: Comparison group 2
Five weekly sessions of online mindfulness training programme and usual care
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change from baseline quality of life score at 8 weeks
Periodo de tiempo: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline quality of life score at 12 weeks
Periodo de tiempo: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline quality of life score at 24 weeks
Periodo de tiempo: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Change from baseline social support score at 8 weeks
Periodo de tiempo: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline social support score at 12 weeks
Periodo de tiempo: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline social support score at 24 weeks
Periodo de tiempo: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline self-efficacy score at 8 weeks
Periodo de tiempo: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline self-efficacy score at 12 weeks
Periodo de tiempo: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline self-efficacy score at 24 weeks
Periodo de tiempo: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline symptom score at 8 weeks
Periodo de tiempo: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline symptom score at 12 weeks
Periodo de tiempo: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline symptom score at 24 weeks
Periodo de tiempo: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline psychosocial adjustment to illness score at 8 weeks
Periodo de tiempo: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline psychosocial adjustment to illness score at 12 weeks
Periodo de tiempo: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline psychosocial adjustment to illness score at 24 weeks
Periodo de tiempo: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline fear of recurrence score at 8 weeks
Periodo de tiempo: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline fear of recurrence score at 12 weeks
Periodo de tiempo: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline fear of recurrence score at 24 weeks
Periodo de tiempo: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline anxiety and depression score at 8 weeks
Periodo de tiempo: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline anxiety and depression score at 12 weeks
Periodo de tiempo: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline anxiety and depression score at 24 weeks
Periodo de tiempo: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks
Change from baseline mindfulness score at 8 weeks
Periodo de tiempo: Change between baseline and at 8 weeks
Change between baseline and at 8 weeks
Change from baseline mindfulness score at 12 weeks
Periodo de tiempo: Change between baseline and at 12 weeks
Change between baseline and at 12 weeks
Change from baseline mindfulness score at 24 weeks
Periodo de tiempo: Change between baseline and at 24 weeks
Change between baseline and at 24 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Karis Cheng, National University of Singapore

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de diciembre de 2016

Finalización primaria (Actual)

14 de marzo de 2020

Finalización del estudio (Actual)

14 de marzo de 2020

Fechas de registro del estudio

Enviado por primera vez

10 de octubre de 2016

Primero enviado que cumplió con los criterios de control de calidad

11 de octubre de 2016

Publicado por primera vez (Estimar)

13 de octubre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de septiembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

22 de septiembre de 2020

Última verificación

1 de septiembre de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • R-545-000-073-592

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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