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Prostatic NeoplasmsNCT04693910

Multimedia-based Hormonal Therapy Information Program for Patients With Prostate Cancer

A study testing Multimedia-Based Hormone Therapy Information Program in people with Prostatic Neoplasms, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Multimedia-Based Hormone Therapy Information Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTaiwan
Study dates
13 May 2019to 31 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan

Other trials in Taiwan

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Multimedia-Based Hormone Therapy Information Program
Keywords
prostate cancer, hormonal therapy, multimedia, self-efficacy, positive thinking
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimedia-Based Hormone Therapy Information ProgramOther

    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.

Study groups in NCT04693910
Study groupRoleWhat they receive
Multimedia information groupExperimentalThe experimental group received a weekly multimedia hormone therapy information program for 6 weeks.
Receives: Other: Multimedia-Based Hormone Therapy Information Program
Routine care groupNo interventionThe control group will receive routine care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: pretest

  2. 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

    Measured: 8 weeks after the pretest

  3. 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

    Measured: 12 weeks after the pretest

  4. 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

    Measured: pretest

  5. 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

    Measured: 8 weeks after the pretest

  6. 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

    Measured: 12 weeks after the pretest

  7. 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.

    Measured: pretest

  8. 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.

    Measured: 8 weeks after the pretest

  9. 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.

    Measured: 12 weeks after the pretest

Secondary outcomes (6)

  1. 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

    Measured: pretest

  2. 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

    Measured: 8 weeks after the pretest

  3. 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

    Measured: 12 weeks after the pretest

  4. 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.

    Measured: pretest

  5. 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.

    Measured: 8 weeks after the pretest

  6. 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.

    Measured: 12 weeks after the pretest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2021
  2. Study start13 May 2019
  3. Primary completion31 Jan 2021
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04693910
Sponsor's protocol ID
201602024B0C501
Status last verified
Mar 2021
First submitted
23 Dec 2020
Last updated
5 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data of this study will be kept and managed by PI of Ching-Hui Chien.

Publications

  • 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.

    PubMed 24184370

  • 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.

    PubMed 8445433

  • 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.

    PubMed 10710976

  • 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.

    PubMed 23398917

  • 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.

    PubMed 28921733

  • 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.

    PubMed 29712628

  • 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.

    PubMed 22246148

  • 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.

    PubMed 29860482

  • 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.

    PubMed 9426724

  • 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.

    PubMed 23210129

  • 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.

    PubMed 31743152

  • 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.

    PubMed 32649333

  • 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.

    PubMed 19854604

  • 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.

    PubMed 14713374

  • 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.

    PubMed 11113727

Questions about this trial

What is this clinical trial studying?

A study testing Multimedia-Based Hormone Therapy Information Program in people with Prostatic Neoplasms, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Assessment of Cancer Therapy-Prostate (FACT-P) (time frame: pretest). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04693910, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.

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