Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer
3 mars 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
80
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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-
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Taoyuan, Taïwan
- Chang Gung Memorial Hospital at Linkou
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Aucune intervention: Routine care group
The control group will receive routine care.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Délai: 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
|
pretest
|
|
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
|
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The Positive Thinking Scale
Délai: 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
Délai: 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.
|
pretest
|
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The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
Délai: 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.
|
8 weeks after the pretest
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The Hormonal Dimension of The Expanded Prostate Cancer Index Composite
Délai: 12 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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12 weeks after the pretest
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The General Self-Efficacy Scale
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Basic and disease information list 1
Délai: pretest
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Age
|
pretest
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Basic and disease information list 2
Délai: pretest
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Education level
|
pretest
|
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Basic and disease information list 3
Délai: pretest
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Marital status
|
pretest
|
|
Basic and disease information list 4
Délai: pretest
|
Religion
|
pretest
|
|
Basic and disease information list 5
Délai: pretest
|
Occupation
|
pretest
|
|
Basic and disease information list 6
Délai: pretest
|
Annual family income (NTD)
|
pretest
|
|
Basic and disease information list 7
Délai: pretest
|
Number of children
|
pretest
|
|
Basic and disease information list 8
Délai: pretest
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Join a support group
|
pretest
|
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Basic and disease information list 9
Délai: pretest
|
Time since diagnosis (months)
|
pretest
|
|
Basic and disease information list 10
Délai: pretest
|
Tumor-node-metastasis Cancer stage
|
pretest
|
|
Basic and disease information list 11
Délai: pretest
|
Gleason score
|
pretest
|
|
Basic and disease information list 12
Délai: pretest
|
Treatment
|
pretest
|
|
Basic and disease information list 13
Délai: pretest
|
History of chronic disease
|
pretest
|
|
Basic and disease information list 14
Délai: pretest
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Living status
|
pretest
|
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Basic and disease information list 15
Délai: pretest
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Height in centimetre
|
pretest
|
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Basic and disease information list 16
Délai: pretest
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Body Mass Index in kg/m2 will be computed from height and body weight
|
pretest
|
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Basic and disease information list 17
Délai: pretest
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Body weight in kilograms
|
pretest
|
|
Basic and disease information list 18
Délai: pretest
|
Waist circumference in centimetre
|
pretest
|
|
Basic and disease information list 19
Délai: pretest
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Serum Prostatic Specific Antigen level
|
pretest
|
|
Basic and disease information list 20
Délai: 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
Délai: 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
Délai: pretest
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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
Délai: 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
Délai: 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
Délai: 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
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Ching-Hui Chien, PhD, National Taipei University of Nursing and Health Sciences, Taipei city, Taiwan
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
13 mai 2019
Achèvement primaire (Réel)
31 janvier 2021
Achèvement de l'étude (Réel)
31 janvier 2021
Dates d'inscription aux études
Première soumission
23 décembre 2020
Première soumission répondant aux critères de contrôle qualité
30 décembre 2020
Première publication (Réel)
5 janvier 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 mars 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 mars 2021
Dernière vérification
1 mars 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201602024B0C501
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
The data of this study will be kept and managed by PI of Ching-Hui Chien.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .