Prostate Cancer Clinical Trial
— Emil2Official title:
Digitally Supporting Lifestyle Changes in Men With Prostate Cancer - Part 2: User-driven Design and Development of a Digital Tool to Support Healthy Lifestyle in Men With Prostate Cancer Based on an Ethnographic Study of the Target Group
Verified date | October 2018 |
Source | Danish Cancer Society |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The emil project aims to design, develop, implement and evaluate a digital service to support
a healthy lifestyle among men with prostate cancer.
In this second study, men with a history of prostate cancer are invited to participate in the
scoping and design of a digital platform, through three iterations of workshops and
individual interviews, which includes prototyping and other ideation processes.
Finally, the men with a history of prostate cancer will be involved in the usability testing
of the design, to ensure a platform fit for use by the intended users.
Status | Active, not recruiting |
Enrollment | 55 |
Est. completion date | October 1, 2018 |
Est. primary completion date | October 1, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - All participants in the study will be men with prostate cancer, included in the Danish Cancer Registry under the IDC-10 code DC61 in the years 2014 or 2015. - All participant will have registered residence in eastern Denmark, either in the Capital Region or in Region Zealand. Exclusion Criteria: - Men with known non-localized prostate cancer at the time of diagnosis. Non-localised cancer will be defined by use of the TNM classification in the Danish Cancer Registry as proposed by Outzen et al [17]: Tis1-4,x and N1-3 and M0,1,x or Tis 1-4,x and N0,x and M1. - Participants will be excused from participation if they do not have sufficient written and spoken Danish language skills for participation in the activities involved in the studies. The researcher will assess whether the participants have sufficient cognitive functions to participate in the study, including be able to contribute to design workshops or report on everyday living. The researcher can also judge from an ethical perspective that the participant, for reasons not stated in the protocol, should be excused from participation in the study. |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Cancer Society Research Center | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Danish Cancer Society | TrygFonden, Denmark, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Digital health service intervention design | The primary outcome is a design product which supports men in their everyday life to have a healthy lifestyle through digital means. A process of 3 iterations of workshops and individual interviews produces data in the form of notes, sketches, pictures, recordings and prototype-products. By iterative analysis and confirmation and ideation in the following iteration, the primary outcome of this process is the design of a digital health service intervention to support men with prostate cancer in a healthy lifestyle. |
5 months. Each iteration of workshops and interviews evaluated to inform the next. Data evaluation points each month. | |
Secondary | Identification of digital capabilities and attitude of men with prostate cancer, in their everyday life | Analysis of digital capabilities and attitude of the participants, from notes, sketches, pictures, recordings and prototype-products of the workshops and interviews. | 5 months. | |
Secondary | Wireframe and mockup | Wireframe and mockup of the intervention, illustrated in the mockup-design tool Mockingbot (mockingbot.com). | 3 months | |
Secondary | Beta-test | Analysis of feedback from a beta-testing of the intervention design. Data collected via e-mail and telephone dialogue with the testers. | 2-5 weeks |
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