Designing a Digital Tool to Support Healthy Lifestyle in Men With Prostate Cancer

NCT03692000 | Unknown

• 1 other identifier: DCS-53232017-2
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Literacy; Computer Literacy; Prostate Cancer

Keywords

eHealth Literacy; Health Literacy; Computer Literacy; Software Design; Healthy Lifestyle; Health Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Identification of digital capabilities and attitude of men with prostate cancer, in their everyday life

  5 months.

• Wireframe and mockup

  3 months

• Beta-test

  2-5 weeks

Study Arms (1)

Men with a history of prostate cancer

Men with a history of prostate cancer invited to participate in design-workshops , interviews or usabilitytesting.

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The Danish population

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Cancer Society: lead
• University of Copenhagen: collaborator
• TrygFonden, Denmark: collaborator

Study Sites (1)

Danish Cancer Society Research Center

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Health Behavior

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Anne Tjønneland, MD PhD DMSc

  Danish Cancer Society Research Center

  STUDY DIRECTOR

• Lars Kayser, MD PhD

  University of Copenhagen, Dept. of Public Health

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 2, 2018
• Study Start: February 23, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-10

Locations

DK (1)