- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02931864
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
Estado
Terminado
Condiciones
Intervención / Tratamiento
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
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Singapore, Singapur
- National University Hospital
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Singapore, Singapur
- National Cancer Centre Singapore
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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 |
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Sin intervención: 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 activo: 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 activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change from baseline quality of life score at 8 weeks
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change from baseline social support score at 8 weeks
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
- 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.
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
Términos MeSH relevantes adicionales
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. .