Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer
NCT ID: NCT04693910
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
80 participants
INTERVENTIONAL
2019-05-13
2021-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Application of 68Ga-PSMA PET in Prostate Cancer
NCT03650946
Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer
NCT01398657
68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
NCT06494696
Development of a Therapeutic Education Program for Patients With Metastatic Prostate Cancer Treated With New Generation Hormone Therapy
NCT04048252
Focal Therapy for Localized Prostate Cancer
NCT03970863
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Multimedia information group
The experimental group received a weekly multimedia hormone therapy information program for 6 weeks.
Multimedia-Based Hormone Therapy Information Program
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.
Routine care group
The control group will receive routine care.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Multimedia-Based Hormone Therapy Information Program
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. patients were at least 20 years old
3. patients were ability to communicate in Chinese or Taiwanese
4. the married partner agrees to study together, or the single patient has a cohabitation partner who agrees to study together.
5. patients or family have a smart phone or tablet and can connect to the Internet.
Exclusion Criteria
2. unknown diagnosis of prostate cancer or unknown disease status
3. patients who received chemotherapy, radiotherapy, radical prostatectomy or other treatments for prostate cancer in the past
4. having history of mental disorder, e.g., phobia, obsessive-compulsive disorder, generalized anxiety, , major depression, mania, manic-depressive psychosis, or dementia
5. the score of Eastern Cooperative Oncology Group performance is ≧ 2
20 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ministry of Science and Technology, Taiwan
OTHER_GOV
Chang Gung Memorial Hospital
OTHER
National Taipei University of Nursing and Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ching-Hui Chien
RN PhD Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ching-Hui Chien, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taipei University of Nursing and Health Sciences, Taipei city, Taiwan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chang Gung Memorial Hospital at Linkou
Taoyuan District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201602024B0C501
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.