Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer
3 de marzo de 2021 actualizado por: Ching-Hui Chien, National Taipei University of Nursing and Health Sciences
Development and Evaluation of the Effectiveness of a Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer
This study takes place in the Divisions of Urology.
Patients who have only received hormonal therapy will be enrolled.
Patients will be randomly sorted into an experimental group and a control group after completing a pretest questionnaire.
The experimental group will receive the the multimedia hormone therapy information program once per week for 6 consecutive weeks, while the control group will receive routine care.
The follow-up data collections will be completed at 8 and 12 weeks after the pretest.
For quantitative measurement, the main variables will be social support, self-efficacy, quality of life, and positive thinking.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study takes place in the Divisions of Urology at Chang Gung Memorial Hospitals.
Patients who have only received hormonal therapy will be enrolled.
With reference to past research findings, self-efficacy theory, and experts' advice, a multimedia hormone therapy information program was developed.
The multimedia hormone therapy information program covered 6 topics, namely the recognition of hormone therapy and multimedia information programs, mindfulness, exercise, stress relief, positive thinking, and prevention or reduction of fatigue.
A pilot study will be conducted to check the feasibility of intervention study design and the effectiveness of the program will be tested.
Patients will be randomly sorted into an experimental group (multimedia information group, n = 36 to 40) and a control group (routine care group, n = 36 to 40) after completing a pretest questionnaire.
The experimental group will receive the multimedia information intervention once per week for 6 consecutive weeks, while the control group will receive routine care.
The follow-up data collections will be completed at 8 and 12 weeks after the pretest.
For quantitative measurement, the main variables will be social support, self-efficacy, quality of life, positive thinking, and satisfaction with program.
Generalized Estimating Equations (GEEs) will be used to o analyze data.
Tipo de estudio
Intervencionista
Inscripción (Actual)
80
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
-
-
-
Taoyuan, Taiwán
- Chang Gung Memorial Hospital at Linkou
-
-
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
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- patients with prostate cancer who were receiving hormonal therapy
- patients were at least 20 years old
- patients were ability to communicate in Chinese or Taiwanese
- the married partner agrees to study together, or the single patient has a cohabitation partner who agrees to study together.
- patients or family have a smart phone or tablet and can connect to the Internet.
Exclusion Criteria:
- having a history of other cancers
- unknown diagnosis of prostate cancer or unknown disease status
- patients who received chemotherapy, radiotherapy, radical prostatectomy or other treatments for prostate cancer in the past
- having history of mental disorder, e.g., phobia, obsessive-compulsive disorder, generalized anxiety, , major depression, mania, manic-depressive psychosis, or dementia
- the score of Eastern Cooperative Oncology Group performance is ≧ 2
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Multimedia information group
The experimental group received a weekly multimedia hormone therapy information program for 6 weeks.
|
The multimedia hormone therapy information program lasted 6 weeks and covered 6 topics, namely the recognition of hormone therapy and multimedia information programs, mindfulness, exercise, stress relief, positive thinking, and prevention or reduction of fatigue.
|
|
Sin intervención: Routine care group
The control group will receive routine care.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Periodo de tiempo: pretest
|
A total of 39 items, including five subdimensions, namely, physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate cancer subscales.
A 5-point scoring method was adopted.
Higher scores indicate higher quality of life
|
pretest
|
|
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Periodo de tiempo: 8 weeks after the pretest
|
A total of 39 items, including five subdimensions, namely, physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate cancer subscales.
A 5-point scoring method was adopted.
Higher scores indicate higher quality of life
|
8 weeks after the pretest
|
|
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Periodo de tiempo: 12 weeks after the pretest
|
A total of 39 items, including five subdimensions, namely, physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate cancer subscales.
A 5-point scoring method was adopted.
Higher scores indicate higher quality of life
|
12 weeks after the pretest
|
|
The Positive Thinking Scale
Periodo de tiempo: pretest
|
A total of 18 items, including two subscales of personal satisfaction and goal pursuit.
A five-point (1-5) scoring method was used.
Higher scores indicate a higher level of positive thinking
|
pretest
|
|
The Positive Thinking Scale
Periodo de tiempo: 8 weeks after the pretest
|
A total of 18 items, including two subscales of personal satisfaction and goal pursuit.
A five-point (1-5) scoring method was used.
Higher scores indicate a higher level of positive thinking
|
8 weeks after the pretest
|
|
The Positive Thinking Scale
Periodo de tiempo: 12 weeks after the pretest
|
A total of 18 items, including two subscales of personal satisfaction and goal pursuit.
A five-point (1-5) scoring method was used.
Higher scores indicate a higher level of positive thinking
|
12 weeks after the pretest
|
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The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
Periodo de tiempo: pretest
|
11 items were used, the score of each item ranges from 0 to 100 points.
Higher scores indicate fewer hormonal symptoms.
|
pretest
|
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The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
Periodo de tiempo: 8 weeks after the pretest
|
11 items were used, the score of each item ranges from 0 to 100 points.
Higher scores indicate fewer hormonal symptoms.
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8 weeks after the pretest
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The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
Periodo de tiempo: 12 weeks after the pretest
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11 items were used, the score of each item ranges from 0 to 100 points.
Higher scores indicate fewer hormonal symptoms.
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12 weeks after the pretest
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The General Self-Efficacy Scale
Periodo de tiempo: pretest
|
The total scale contains 10 items and a 4-point (1-4) scoring method was adopted.
Higher scores indicate higher self-efficacy
|
pretest
|
|
The General Self-Efficacy Scale
Periodo de tiempo: 8 weeks after the pretest
|
The total scale contains 10 items and a 4-point (1-4) scoring method was adopted.
Higher scores indicate higher self-efficacy
|
8 weeks after the pretest
|
|
The General Self-Efficacy Scale
Periodo de tiempo: 12 weeks after the pretest
|
The total scale contains 10 items and a 4-point (1-4) scoring method was adopted.
Higher scores indicate higher self-efficacy
|
12 weeks after the pretest
|
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The Social Support Scale
Periodo de tiempo: pretest
|
A total of 16 items, including four sub-scales of emotional, informational, appraisal, and instrumental support.
A 4-point scoring method (0-3) was used.
Higher scores indicate stronger support.
|
pretest
|
|
The Social Support Scale
Periodo de tiempo: 8 weeks after the pretest
|
A total of 16 items, including four sub-scales of emotional, informational, appraisal, and instrumental support.
A 4-point scoring method (0-3) was used.
Higher scores indicate stronger support.
|
8 weeks after the pretest
|
|
The Social Support Scale
Periodo de tiempo: 12 weeks after the pretest
|
A total of 16 items, including four sub-scales of emotional, informational, appraisal, and instrumental support.
A 4-point scoring method (0-3) was used.
Higher scores indicate stronger support.
|
12 weeks after the pretest
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Basic and disease information list 1
Periodo de tiempo: pretest
|
Age
|
pretest
|
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Basic and disease information list 2
Periodo de tiempo: pretest
|
Education level
|
pretest
|
|
Basic and disease information list 3
Periodo de tiempo: pretest
|
Marital status
|
pretest
|
|
Basic and disease information list 4
Periodo de tiempo: pretest
|
Religion
|
pretest
|
|
Basic and disease information list 5
Periodo de tiempo: pretest
|
Occupation
|
pretest
|
|
Basic and disease information list 6
Periodo de tiempo: pretest
|
Annual family income (NTD)
|
pretest
|
|
Basic and disease information list 7
Periodo de tiempo: pretest
|
Number of children
|
pretest
|
|
Basic and disease information list 8
Periodo de tiempo: pretest
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Join a support group
|
pretest
|
|
Basic and disease information list 9
Periodo de tiempo: pretest
|
Time since diagnosis (months)
|
pretest
|
|
Basic and disease information list 10
Periodo de tiempo: pretest
|
Tumor-node-metastasis Cancer stage
|
pretest
|
|
Basic and disease information list 11
Periodo de tiempo: pretest
|
Gleason score
|
pretest
|
|
Basic and disease information list 12
Periodo de tiempo: pretest
|
Treatment
|
pretest
|
|
Basic and disease information list 13
Periodo de tiempo: pretest
|
History of chronic disease
|
pretest
|
|
Basic and disease information list 14
Periodo de tiempo: pretest
|
Living status
|
pretest
|
|
Basic and disease information list 15
Periodo de tiempo: pretest
|
Height in centimetre
|
pretest
|
|
Basic and disease information list 16
Periodo de tiempo: pretest
|
Body Mass Index in kg/m2 will be computed from height and body weight
|
pretest
|
|
Basic and disease information list 17
Periodo de tiempo: pretest
|
Body weight in kilograms
|
pretest
|
|
Basic and disease information list 18
Periodo de tiempo: pretest
|
Waist circumference in centimetre
|
pretest
|
|
Basic and disease information list 19
Periodo de tiempo: pretest
|
Serum Prostatic Specific Antigen level
|
pretest
|
|
Basic and disease information list 20
Periodo de tiempo: 8 weeks after the pretest
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Serum Prostatic Specific Antigen level
|
8 weeks after the pretest
|
|
Basic and disease information list 21
Periodo de tiempo: 12 weeks after the pretest
|
Serum Prostatic Specific Antigen level
|
12 weeks after the pretest
|
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Basic and disease information list 22
Periodo de tiempo: pretest
|
Perceived health status.
A 11-point (0-100) scoring method was used.
Higher scores indicate better health condition.
|
pretest
|
|
Basic and disease information list 23
Periodo de tiempo: 8 weeks after the pretest
|
Perceived health status.
A 11-point (0-100) scoring method was used.
Higher scores indicate better health condition.
|
8 weeks after the pretest
|
|
Basic and disease information list 24
Periodo de tiempo: 12 weeks after the pretest
|
Perceived health status.
A 11-point (0-100) scoring method was used.
Higher scores indicate better health condition.
|
12 weeks after the pretest
|
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List of satisfaction with Program
Periodo de tiempo: 8 weeks after the pretest
|
Five items were self-designed to understand the satisfaction of men in the experimental group.
A 11-point (0-100) scoring method was used.
Higher scores indicate higher satisfaction.
|
8 weeks after the pretest
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Ching-Hui Chien, PhD, National Taipei University of Nursing and Health Sciences, Taipei city, Taiwan
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
- Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
- Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905. doi: 10.1016/s0090-4295(00)00858-x.
- Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ. Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology. 1997 Dec;50(6):920-8. doi: 10.1016/S0090-4295(97)00459-7.
- Cary KC, Singla N, Cowan JE, Carroll PR, Cooperberg MR. Impact of androgen deprivation therapy on mental and emotional well-being in men with prostate cancer: analysis from the CaPSURE registry. J Urol. 2014 Apr;191(4):964-70. doi: 10.1016/j.juro.2013.10.098. Epub 2013 Oct 29.
- Cheung SK, Sun SY. Assessment of optimistic self-beliefs: further validation of the Chinese version of the General Self-Efficacy Scale. Psychol Rep. 1999 Dec;85(3 Pt 2):1221-4. doi: 10.2466/pr0.1999.85.3f.1221.
- Chien CH, Liu KL, Chien HT, Liu HE. The effects of psychosocial strategies on anxiety and depression of patients diagnosed with prostate cancer: a systematic review. Int J Nurs Stud. 2014 Jan;51(1):28-38. doi: 10.1016/j.ijnurstu.2012.12.019. Epub 2013 Feb 8.
- Chien CH, Chuang CK, Liu KL, Wu CT, Pang ST, Tsay PK, Chang YH, Huang XY, Liu HE. Effects of individual and partner factors on anxiety and depression in Taiwanese prostate cancer patients: A longitudinal study. Eur J Cancer Care (Engl). 2018 Mar;27(2):e12753. doi: 10.1111/ecc.12753. Epub 2017 Sep 18.
- Cockle-Hearne J, Barnett D, Hicks J, Simpson M, White I, Faithfull S. A Web-Based Intervention to Reduce Distress After Prostate Cancer Treatment: Development and Feasibility of the Getting Down to Coping Program in Two Different Clinical Settings. JMIR Cancer. 2018 Apr 30;4(1):e8. doi: 10.2196/cancer.8918.
- Diefenbach MA, Mohamed NE, Butz BP, Bar-Chama N, Stock R, Cesaretti J, Hassan W, Samadi D, Hall SJ. Acceptability and preliminary feasibility of an internet/CD-ROM-based education and decision program for early-stage prostate cancer patients: randomized pilot study. J Med Internet Res. 2012 Jan 13;14(1):e6. doi: 10.2196/jmir.1891.
- Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Akinyemiju TF, Al Lami FH, Alam T, Alizadeh-Navaei R, Allen C, Alsharif U, Alvis-Guzman N, Amini E, Anderson BO, Aremu O, Artaman A, Asgedom SW, Assadi R, Atey TM, Avila-Burgos L, Awasthi A, Ba Saleem HO, Barac A, Bennett JR, Bensenor IM, Bhakta N, Brenner H, Cahuana-Hurtado L, Castaneda-Orjuela CA, Catala-Lopez F, Choi JJ, Christopher DJ, Chung SC, Curado MP, Dandona L, Dandona R, das Neves J, Dey S, Dharmaratne SD, Doku DT, Driscoll TR, Dubey M, Ebrahimi H, Edessa D, El-Khatib Z, Endries AY, Fischer F, Force LM, Foreman KJ, Gebrehiwot SW, Gopalani SV, Grosso G, Gupta R, Gyawali B, Hamadeh RR, Hamidi S, Harvey J, Hassen HY, Hay RJ, Hay SI, Heibati B, Hiluf MK, Horita N, Hosgood HD, Ilesanmi OS, Innos K, Islami F, Jakovljevic MB, Johnson SC, Jonas JB, Kasaeian A, Kassa TD, Khader YS, Khan EA, Khan G, Khang YH, Khosravi MH, Khubchandani J, Kopec JA, Kumar GA, Kutz M, Lad DP, Lafranconi A, Lan Q, Legesse Y, Leigh J, Linn S, Lunevicius R, Majeed A, Malekzadeh R, Malta DC, Mantovani LG, McMahon BJ, Meier T, Melaku YA, Melku M, Memiah P, Mendoza W, Meretoja TJ, Mezgebe HB, Miller TR, Mohammed S, Mokdad AH, Moosazadeh M, Moraga P, Mousavi SM, Nangia V, Nguyen CT, Nong VM, Ogbo FA, Olagunju AT, Pa M, Park EK, Patel T, Pereira DM, Pishgar F, Postma MJ, Pourmalek F, Qorbani M, Rafay A, Rawaf S, Rawaf DL, Roshandel G, Safiri S, Salimzadeh H, Sanabria JR, Santric Milicevic MM, Sartorius B, Satpathy M, Sepanlou SG, Shackelford KA, Shaikh MA, Sharif-Alhoseini M, She J, Shin MJ, Shiue I, Shrime MG, Sinke AH, Sisay M, Sligar A, Sufiyan MB, Sykes BL, Tabares-Seisdedos R, Tessema GA, Topor-Madry R, Tran TT, Tran BX, Ukwaja KN, Vlassov VV, Vollset SE, Weiderpass E, Williams HC, Yimer NB, Yonemoto N, Younis MZ, Murray CJL, Naghavi M. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2018 Nov 1;4(11):1553-1568. doi: 10.1001/jamaoncol.2018.2706.
- Keating NL, O'Malley A, Freedland SJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy: observational study of veterans with prostate cancer. J Natl Cancer Inst. 2012 Oct 3;104(19):1518-23. doi: 10.1093/jnci/djs376. No abstract available.
- Chien CH, Chuang CK, Liu KL, Wu CT, Pang ST, Chang YH. Health-Related Quality of Life and Its Associated Factors in Prostate Cancer Patients Who Receive Androgen Deprivation Therapy. Cancer Nurs. 2021 Jan/Feb;44(1):E34-E42. doi: 10.1097/NCC.0000000000000752.
- Chien CH, Chuang CK, Liu KL, Pang ST, Wu CT, Chang YH. Exploring the Positive Thinking of Patients With Prostate Cancer: Self-efficacy as a Mediator. Cancer Nurs. 2022 Mar-Apr 01;45(2):E329-E337. doi: 10.1097/NCC.0000000000000868.
- Loiselle CG, Edgar L, Batist G, Lu J, Lauzier S. The impact of a multimedia informational intervention on psychosocial adjustment among individuals with newly diagnosed breast or prostate cancer: a feasibility study. Patient Educ Couns. 2010 Jul;80(1):48-55. doi: 10.1016/j.pec.2009.09.026. Epub 2009 Oct 24.
- Van Gerven PW, Paas F, Van Merrienboer JJ, Hendriks M, Schmidt HG. The efficiency of multimedia learning into old age. Br J Educ Psychol. 2003 Dec;73(Pt 4):489-505. doi: 10.1348/000709903322591208.
- Wootten AC, Abbott JA, Meyer D, Chisholm K, Austin DW, Klein B, McCabe M, Murphy DG, Costello AJ. Preliminary results of a randomised controlled trial of an online psychological intervention to reduce distress in men treated for localised prostate cancer. Eur Urol. 2015 Sep;68(3):471-9. doi: 10.1016/j.eururo.2014.10.024. Epub 2014 Oct 28.
- Zhang Q, Zhao H, Zheng Y. Effectiveness of mindfulness-based stress reduction (MBSR) on symptom variables and health-related quality of life in breast cancer patients-a systematic review and meta-analysis. Support Care Cancer. 2019 Mar;27(3):771-781. doi: 10.1007/s00520-018-4570-x. Epub 2018 Nov 28.
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)
13 de mayo de 2019
Finalización primaria (Actual)
31 de enero de 2021
Finalización del estudio (Actual)
31 de enero de 2021
Fechas de registro del estudio
Enviado por primera vez
23 de diciembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
30 de diciembre de 2020
Publicado por primera vez (Actual)
5 de enero de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
3 de marzo de 2021
Última verificación
1 de marzo de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201602024B0C501
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
The data of this study will be kept and managed by PI of Ching-Hui Chien.
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
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. .