Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer
2021年3月3日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Taoyuan、台湾
- Chang Gung Memorial Hospital at Linkou
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Multimedia information group
The experimental group received a weekly multimedia hormone therapy information program for 6 weeks.
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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.
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无干预：Routine care group
The control group will receive routine care.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional Assessment of Cancer Therapy-Prostate (FACT-P)
大体时间：pretest
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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
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pretest
|
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Functional Assessment of Cancer Therapy-Prostate (FACT-P)
大体时间：8 weeks after the pretest
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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
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8 weeks after the pretest
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Functional Assessment of Cancer Therapy-Prostate (FACT-P)
大体时间：12 weeks after the pretest
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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
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12 weeks after the pretest
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The Positive Thinking Scale
大体时间：pretest
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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
大体时间：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
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8 weeks after the pretest
|
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The Positive Thinking Scale
大体时间：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
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12 weeks after the pretest
|
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The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
大体时间：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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pretest
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The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
大体时间：8 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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8 weeks after the pretest
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The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
大体时间：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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The General Self-Efficacy Scale
大体时间：pretest
|
The total scale contains 10 items and a 4-point (1-4) scoring method was adopted.
Higher scores indicate higher self-efficacy
|
pretest
|
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The General Self-Efficacy Scale
大体时间：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
|
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The General Self-Efficacy Scale
大体时间：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
大体时间：pretest
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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
大体时间：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
大体时间：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
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Basic and disease information list 1
大体时间：pretest
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Age
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pretest
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Basic and disease information list 2
大体时间：pretest
|
Education level
|
pretest
|
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Basic and disease information list 3
大体时间：pretest
|
Marital status
|
pretest
|
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Basic and disease information list 4
大体时间：pretest
|
Religion
|
pretest
|
|
Basic and disease information list 5
大体时间：pretest
|
Occupation
|
pretest
|
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Basic and disease information list 6
大体时间：pretest
|
Annual family income (NTD)
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pretest
|
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Basic and disease information list 7
大体时间：pretest
|
Number of children
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pretest
|
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Basic and disease information list 8
大体时间：pretest
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Join a support group
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pretest
|
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Basic and disease information list 9
大体时间：pretest
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Time since diagnosis (months)
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pretest
|
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Basic and disease information list 10
大体时间：pretest
|
Tumor-node-metastasis Cancer stage
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pretest
|
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Basic and disease information list 11
大体时间：pretest
|
Gleason score
|
pretest
|
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Basic and disease information list 12
大体时间：pretest
|
Treatment
|
pretest
|
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Basic and disease information list 13
大体时间：pretest
|
History of chronic disease
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pretest
|
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Basic and disease information list 14
大体时间：pretest
|
Living status
|
pretest
|
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Basic and disease information list 15
大体时间：pretest
|
Height in centimetre
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pretest
|
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Basic and disease information list 16
大体时间：pretest
|
Body Mass Index in kg/m2 will be computed from height and body weight
|
pretest
|
|
Basic and disease information list 17
大体时间：pretest
|
Body weight in kilograms
|
pretest
|
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Basic and disease information list 18
大体时间：pretest
|
Waist circumference in centimetre
|
pretest
|
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Basic and disease information list 19
大体时间：pretest
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Serum Prostatic Specific Antigen level
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pretest
|
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Basic and disease information list 20
大体时间：8 weeks after the pretest
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Serum Prostatic Specific Antigen level
|
8 weeks after the pretest
|
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Basic and disease information list 21
大体时间：12 weeks after the pretest
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Serum Prostatic Specific Antigen level
|
12 weeks after the pretest
|
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Basic and disease information list 22
大体时间：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
大体时间：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
大体时间：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
大体时间：8 weeks after the pretest
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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
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ching-Hui Chien, PhD、National Taipei University of Nursing and Health Sciences, Taipei city, Taiwan
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年5月13日
初级完成 (实际的)
2021年1月31日
研究完成 (实际的)
2021年1月31日
研究注册日期
首次提交
2020年12月23日
首先提交符合 QC 标准的
2020年12月30日
首次发布 (实际的)
2021年1月5日
研究记录更新
最后更新发布 (实际的)
2021年3月5日
上次提交的符合 QC 标准的更新
2021年3月3日
最后验证
2021年3月1日
更多信息
与本研究相关的术语
其他研究编号
- 201602024B0C501
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
The data of this study will be kept and managed by PI of Ching-Hui Chien.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.