A Mobile SMART Exercise Support Program to Improve Fatigue in Lung Cancer Patients - A RCT
29 de mayo de 2022 actualizado por: Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong
A Brief Mobile SMART Exercise Support Program to Improve Fatigue in Patients With Advanced Lung Cancer - A Pragmatic Randomized Controlled Trial With Outcome and Process Evaluation
Lung cancer (LC) is a common cancer in the world.
Among all symptoms, Fatigue is considered as the most distressing medical condition of LC.
Prior studies revealed that physical activity effectively relieve fatigue and related problems.
The current study attempt to explore the effectiveness of SMART Exercise Support Program (SES) with the use of mobile instant messaging application, on reducing symptoms such as fatigue, and improving physical activity level, physical fitness performance, sleep quality and habits, and quality of life in advanced lung cancer (ALC) patients.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Lung cancer (LC) is the most and second most common cancer globally and locally, respectively. Nearly half of LC patients are diagnosed in the advanced stage. Fatigue is perceived to be the most distressing symptom. Physical activity has been proposed as an alternative treatment to relieve fatigue and related problems.
Mobile instant messaging applications (e.g. WhatsApp/WeChat) are popular and inexpensive for interactive messaging. A systematic review showed a majority of messaging interventions were effective in diabetes self-management, weight loss, physical activity (PA), smoking cessation, and medication adherence.
The proposed randomized controlled trial (RCT) aims to examine the effectiveness of SES on relieving fatigue, pain, dyspnea, happiness, anxiety and depression symptoms, physical activity level, physical fitness performance, sleep quality and habits, and quality of life in ALC patients (SES group), compared to the General Hygiene Information (GHI, control) group.
Questionnaires and simple fitness tests will be used at baseline, 6-week, and 24-week assessments. Qualitative feedback will be obtained at the completion of the trial.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
120
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.
Estudio Contacto
- Nombre: Agnes Lai, PhD
- Número de teléfono: 852-3917-6328
- Correo electrónico: agneslai@hku.hk
Copia de seguridad de contactos de estudio
- Nombre: George Cheung, MPhil
- Número de teléfono: 852-3917-6563
- Correo electrónico: ocgeorge@hku.hk
Ubicaciones de estudio
-
-
-
Hong Kong, Hong Kong
- Reclutamiento
- Queen Mary Hospital
-
Contacto:
- Agnes Lai, PhD
- Número de teléfono: 852-3917-6283
- Correo electrónico: agneslai@hku.hk
-
Contacto:
- David Lam, PhD
- Número de teléfono: 852-2255-4455
- Correo electrónico: slnga@hku.hk
-
Investigador principal:
- Agnes YK Lai, PhD
-
-
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
18 años a 100 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Aged 18 years and above;
- Diagnosis of Stage III or IV non-small cell lung cancer;
- Edmonton Symptom Assessment System Scale fatigue symptom score ≥4 out of 10
- Self-reported engagement of <150 minutes of moderate intensity PA each week,
- Ambulatory and capable of all self-care activities (European Co-operative Oncology Group (ECOG) Performance Status of ≤2)
- Either undergoing or finished oncology therapy, biological agents and/or support care;
- Mentally, cognitively and physically fit to join the trial as determined by the doctor in-charge and responsible clinical investigators;
- Able to speak and read Chinese;
- Willing to complete the patient-reported outcome questionnaire;
- Completion of the Physical Activity Readiness Questionnaire; and
- Possession of a smartphone with instant messaging functions such as WhatsApp or WeChat.
Exclusion Criteria:
- Those preparing for lung operation;
- Skeletal fragility;
- Serious active infection;
- Inability to walk;
- Previously untreated symptomatic brain metastases;
- Severe respiratory insufficiency;
- Uncontrolled pain; or
- Diagnosed psychiatric illness with or without medication such as major depressive disorder.
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Brief mobile SMART Exercise Support Program
Patients will receive a brief SMART Exercise individual session with instant messages and telephone coaching for exercise habit formation and maintenance.
|
Patients will receive 1) a brief SMART Exercise individual face-to-face session; 2) a theory-based instant messaging (WhatsApp/WeChat) and telephone-delivered health coaching on a 2-stage tapering schedule.
Stage 1 (week 1 to 6): daily messages and two biweekly phone calls for exercise habit formation.
Stage 2 (week 7 to 12): messages twice a week and monthly phone calls for exercise habit maintenance.
|
|
Comparador de placebos: General Hygiene Information (GHI)
Patients will receive an individual session, instant messages and telephone coaching regarding general hygiene information.
|
Patients will receive 1) a brief SMART Exercise individual face-to-face session; 2) a theory-based instant messaging (WhatsApp/WeChat) and telephone-delivered health coaching on a 2-stage tapering schedule.
Stage 1 (week 1 to 6): daily messages and two biweekly phone calls for exercise habit formation.
Stage 2 (week 7 to 12): messages twice a week and monthly phone calls for exercise habit maintenance.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in fatigue level
Periodo de tiempo: Baseline and 6 weeks
|
Measured by a 13-item Functional Assessment of Cancer Therapy - Fatigue subscale.
The level of fatigue is measured on a five-point Likert scale.
The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
|
Baseline and 6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in fatigue level
Periodo de tiempo: Baseline and 6 months
|
Measured by a 13-item Functional Assessment of Cancer Therapy - Fatigue subscale.
The level of fatigue is measured on a five-point Likert scale.
The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
|
Baseline and 6 months
|
|
Change in anxiety symptoms
Periodo de tiempo: Baseline, 6 weeks, 6 months
|
Measured by a 7-item Generalised Anxiety Disorder Assessment.
Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale.
The total score ranges from 0 to 21.
The higher scores the greater severity of anxiety symptoms.
|
Baseline, 6 weeks, 6 months
|
|
Change in depression symptoms
Periodo de tiempo: Baseline, 6 weeks, 6 months
|
Measured by a 9-item Patient Health Questionaire.
Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale.
The total score ranges from 0 to 27.
The higher scores the greater severity of depression symptoms.
|
Baseline, 6 weeks, 6 months
|
|
Change in physical activity level
Periodo de tiempo: Baseline, 6 weeks, 6 months
|
Measured the days and duration of physical activity level and sitting time in the past 7 days by the International Physical Activity Questionnaire (short version) with 4 questions.
|
Baseline, 6 weeks, 6 months
|
|
Change in sleep quality
Periodo de tiempo: Baseline, 6 weeks, 6 months
|
Measured by 7-item Severe Insomnia Index.
Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale.
The total score ranges from 0 to 28.
The higher scores the greater severity of insomnia.
|
Baseline, 6 weeks, 6 months
|
|
Change in health-related quality of life
Periodo de tiempo: Baseline, 6 weeks, 6 months
|
Measured by a 30-item European Organization for Research and Treatment of Cancer and Lung Module.
It contains five functioning scales (physical, social, role, cognitive, and emotional functioning), and eight symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, and diarrhoea), and financial impact, and overall quality of life.
All scale scores are linearly converted to a range from 0 to 100.
Higher scores indicate better functioning for the functioning scales and global QOL; for the symptom scales, higher scores indicate higher symptom burden.
|
Baseline, 6 weeks, 6 months
|
|
Change in happiness level
Periodo de tiempo: Baseline, 6 weeks, 6 months
|
Measured by 4-item Subjective Happiness Scale with a 7-point Likert scale.
Total scores range from 4 to 28.
The highest scores reflect greater happiness.
|
Baseline, 6 weeks, 6 months
|
|
Change in cancer-related symptoms
Periodo de tiempo: Baseline, 6 weeks and 6 months
|
Measured by 3 items of the Edmonton Symptom Assessment System Scale.
The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity.
|
Baseline, 6 weeks and 6 months
|
|
Change in acceptance of illness
Periodo de tiempo: Baseline, 6 weeks and 6 months
|
Measured by a 5-item subscale of Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire
|
Baseline, 6 weeks and 6 months
|
|
Change in exercise self-efficacy
Periodo de tiempo: Baseline, 6 weeks and 6 months
|
Measured by a question with a scale from 0 to 10; "0" indicates no exercise self-efficacy, while "10" indicates highest level of exercise self-efficacy.
|
Baseline, 6 weeks and 6 months
|
|
Change in social and family support
Periodo de tiempo: Baseline, 6 weeks and 6 months
|
Measured by 8-item family and friend subscales of multidimensional Scale of Perceived Social Support with a 7-point Likert scale.
Each scale ranges from 4 to 28.
A higher score equates with higher social support.
|
Baseline, 6 weeks and 6 months
|
|
Change in grip strength
Periodo de tiempo: Baseline, 6 weeks and 6 months
|
Measured by a dynamometer
|
Baseline, 6 weeks and 6 months
|
|
Change in lower limb strength
Periodo de tiempo: Baseline, 6 weeks, and 6 months
|
Measured by 30-second chair stand test.
|
Baseline, 6 weeks, and 6 months
|
|
Change in balance
Periodo de tiempo: Baseline, 6 weeks and 6 months
|
Measured by single-leg-stance test
|
Baseline, 6 weeks and 6 months
|
|
Change in flexibility
Periodo de tiempo: Baseline, 6 weeks, and 6 months
|
Measured by chair sit and reach test
|
Baseline, 6 weeks, and 6 months
|
|
Change in objective physical activity levels, including duration, frequency and intensity
Periodo de tiempo: Baseline, 6 weeks, and 6 months
|
Measured by a waist-worn accelerometer
|
Baseline, 6 weeks, and 6 months
|
|
Change in sleep and wake intervals
Periodo de tiempo: Baseline, 6 weeks , and 6 months
|
Measured by watch-like activity monitor
|
Baseline, 6 weeks , and 6 months
|
|
Change in exercise capacity
Periodo de tiempo: Baseline, 6 weeks and 6 months
|
Measured by a 6-min walk test
|
Baseline, 6 weeks and 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Agnes YK Lai, PhD, School of Nursing, The University of Hong Kong
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.
- Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
- Ho RT, Fong TC. Factor structure of the Chinese version of the Pittsburgh sleep quality index in breast cancer patients. Sleep Med. 2014 May;15(5):565-9. doi: 10.1016/j.sleep.2013.10.019. Epub 2014 Feb 18.
- Koller M, Hjermstad MJ, Tomaszewski KA, Tomaszewska IM, Hornslien K, Harle A, Arraras JI, Morag O, Pompili C, Ioannidis G, Georgiou M, Navarra C, Chie WC, Johnson CD, Himpel A, Schulz C, Bohrer T, Janssens A, Kulis D, Bottomley A. An international study to revise the EORTC questionnaire for assessing quality of life in lung cancer patients. Ann Oncol. 2017 Nov 1;28(11):2874-2881. doi: 10.1093/annonc/mdx453.
- Chie WC, Yang CH, Hsu C, Yang PC. Quality of life of lung cancer patients: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and QLQ-LC13. Qual Life Res. 2004 Feb;13(1):257-62. doi: 10.1023/B:QURE.0000015295.74812.06.
- Nan H, Ni MY, Lee PH, Tam WW, Lam TH, Leung GM, McDowell I. Psychometric evaluation of the Chinese version of the Subjective Happiness Scale: evidence from the Hong Kong FAMILY Cohort. Int J Behav Med. 2014 Aug;21(4):646-52. doi: 10.1007/s12529-014-9389-3.
- Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
- Jones CJ, Rikli RE, Max J, Noffal G. The reliability and validity of a chair sit-and-reach test as a measure of hamstring flexibility in older adults. Res Q Exerc Sport. 1998 Dec;69(4):338-43. doi: 10.1080/02701367.1998.10607708.
- Newton R. Review of tests of standing balance abilities. Brain Inj. 1989 Oct-Dec;3(4):335-43. Review.
- Santos-Lozano A, Santin-Medeiros F, Cardon G, Torres-Luque G, Bailon R, Bergmeir C, Ruiz JR, Lucia A, Garatachea N. Actigraph GT3X: validation and determination of physical activity intensity cut points. Int J Sports Med. 2013 Nov;34(11):975-82. doi: 10.1055/s-0033-1337945. Epub 2013 May 22.
- Bonomi AG, Westerterp KR. Advances in physical activity monitoring and lifestyle interventions in obesity: a review. Int J Obes (Lond). 2012 Feb;36(2):167-77. doi: 10.1038/ijo.2011.99. Epub 2011 May 17. Review.
- Kushida CA, Chang A, Gadkary C, Guilleminault C, Carrillo O, Dement WC. Comparison of actigraphic, polysomnographic, and subjective assessment of sleep parameters in sleep-disordered patients. Sleep Med. 2001 Sep;2(5):389-96.
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)
1 de mayo de 2022
Finalización primaria (Anticipado)
30 de junio de 2023
Finalización del estudio (Anticipado)
30 de septiembre de 2024
Fechas de registro del estudio
Enviado por primera vez
11 de abril de 2022
Primero enviado que cumplió con los criterios de control de calidad
11 de abril de 2022
Publicado por primera vez (Actual)
15 de abril de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2022
Última verificación
1 de mayo de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UW21-148
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Descripción del plan IPD
For those who want the patient data, please contact PI directly by written email.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
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. .