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| Name | Class |
|---|---|
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
| Chang Gung Memorial Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimedia information group | Experimental | The experimental group received a weekly multimedia hormone therapy information program for 6 weeks. |
|
| Routine care group | No Intervention | The control group will receive routine care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimedia-Based Hormone Therapy Information Program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy-Prostate (FACT-P) | 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) | 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) | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The General Self-Efficacy Scale | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Basic and disease information list 1 | Age | pretest |
| Basic and disease information list 2 | Education level | pretest |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ching-Hui Chien, PhD | National Taipei University of Nursing and Health Sciences, Taipei city, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital at Linkou | Taoyuan | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24184370 | Background | 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. | |
| 8445433 | Background | 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. |
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The data of this study will be kept and managed by PI of Ching-Hui Chien.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| 12 weeks after the pretest |
| The Hormonal Dimension of The Expanded Prostate Cancer Index Composite | 11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms. | pretest |
| The Hormonal Dimension of The Expanded Prostate Cancer Index Composite | 11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms. | 8 weeks after the pretest |
| The Hormonal Dimension of The Expanded Prostate Cancer Index Composite | 11 items were used, the score of each item ranges from 0 to 100 points. Higher scores indicate fewer hormonal symptoms. | 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
| 8 weeks after the pretest |
| The General Self-Efficacy Scale | 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 |
| The Social Support Scale | 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 | 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 | 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 |
| Basic and disease information list 3 | Marital status | pretest |
| Basic and disease information list 4 | Religion | pretest |
| Basic and disease information list 5 | Occupation | pretest |
| Basic and disease information list 6 | Annual family income (NTD) | pretest |
| Basic and disease information list 7 | Number of children | pretest |
| Basic and disease information list 8 | Join a support group | pretest |
| Basic and disease information list 9 | Time since diagnosis (months) | pretest |
| Basic and disease information list 10 | Tumor-node-metastasis Cancer stage | pretest |
| Basic and disease information list 11 | Gleason score | pretest |
| Basic and disease information list 12 | Treatment | pretest |
| Basic and disease information list 13 | History of chronic disease | pretest |
| Basic and disease information list 14 | Living status | pretest |
| Basic and disease information list 15 | Height in centimetre | pretest |
| Basic and disease information list 16 | Body Mass Index in kg/m2 will be computed from height and body weight | pretest |
| Basic and disease information list 17 | Body weight in kilograms | pretest |
| Basic and disease information list 18 | Waist circumference in centimetre | pretest |
| Basic and disease information list 19 | Serum Prostatic Specific Antigen level | pretest |
| Basic and disease information list 20 | Serum Prostatic Specific Antigen level | 8 weeks after the pretest |
| Basic and disease information list 21 | Serum Prostatic Specific Antigen level | 12 weeks after the pretest |
| Basic and disease information list 22 | 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 | 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 | Perceived health status. A 11-point (0-100) scoring method was used. Higher scores indicate better health condition. | 12 weeks after the pretest |
| List of satisfaction with Program | 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 |
| 10710976 | Background | 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. |
| 23398917 | Background | 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. |
| 28921733 | Background | 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. |
| 29712628 | Background | 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. |
| 22246148 | Background | 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. |
| 29860482 | Background | 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. |
| 9426724 | Background | 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. |
| 23210129 | Background | 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. |
| 31743152 | Background | 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. |
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| 19854604 | Background | 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. |
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| 30488223 | Background | 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. |
| 38155164 | Derived | Chien CH, Liu KL, Chuang CK, Wu CT, Chang YH, Yu KJ. Multimedia-based hormone therapy information program for patients with prostate cancer: the result of a randomized pilot study. Sci Rep. 2023 Dec 27;13(1):23022. doi: 10.1038/s41598-023-50006-6. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |