Health LiteracyEmil2NCT03692000
Designing a Digital Tool to Support Healthy Lifestyle in Men With Prostate Cancer
An observational study of Health Literacy and Computer Literacy, run by Danish Cancer Society at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Health Literacy, Computer Literacy, Prostate Cancer
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Feb 2018to 1 Oct 2018
- Phase
- Observational
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The Danish population
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
In this user-driven study, the methods will be workshops, interviews, usability testing and a concluding proof of concept testing.
Workshops constitutes the bigger part of the user-driven design and ideation in this project. In workshops a group of people will generate a synergy that opens up for new ideas in a framed setting. The workshop format uses methods such as affinity diagrams; innovation jams; and ideation guided through artefacts such as Lego or paper cuts, with the researcher as the facilitator. After analysing the outcome of each design iteration, the findings will be incorporated into the design and focus the planning of the succeeding workshops in an iterative process.
The usability of the design will be tested in between workshops in interviews. The test will be performed by think aloud testing with the current prototype, recording for data collection and researchers in the room to observe, facilitate and probe for reflection.
For a more elaborate usability testing to conclude the design phase, a proof of concept will be performed. In this living lab scenario, the tool will be used at home by end-users in the intended way. Issues with technical functionality, user interphase, data management and workflow will surface and can be corrected during the proof of concept, thus consolidating the service before the feasibility study. Data collection from this part of the study will be by ongoing dialogue with participants, by e-mail and telephone.
To provide the broadest possible foundation for recruitment in terms of diversity in lifestyle and socioeconomic status, invitation to the study is done by mail directly to a randomly chosen group of men with prostate cancer.
All iterations will be based on the results of the previous. The first iteration is based on the ethnographic input from the first study.
All participants in study 2 will be met with a baseline questionnaire to evaluate digital readiness and e-health literacy and adjust participant configuration to ensure diversity. The questionnaire include self-reported educational level, health issues, treatments, diet, physical activity level and other lifestyle factors as well as eHLQ as part of the READHY questionnaire toolkit. The 13 dimensions of READHY comes from heiQ, HLQ and eHLQ, and work as a multidimensional validated robust psychometric instrument evaluation and can be used in combination to describe user's health technology readiness level and degree of enablement.
Each activity of the user-driven design process will be documented in a report, that will serve as the data foundation for a scientific publication.
- Conditions
- Health Literacy, Computer Literacy, Prostate Cancer
- Keywords
- eHealth Literacy, Health Literacy, Computer Literacy, Software Design, Healthy Lifestyle, Health Behavior
- Medical subject headings
- Prostatic Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Men with a history of prostate cancer | Men with a history of prostate cancer invited to participate in design-workshops , interviews or usabilitytesting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Analysis of digital capabilities and attitude of the participants, from notes, sketches, pictures, recordings and prototype-products of the workshops and interviews.
Measured: 5 months.
Wireframe and mockup
Wireframe and mockup of the intervention, illustrated in the mockup-design tool Mockingbot (mockingbot.com).
Measured: 3 months
Beta-test
Analysis of feedback from a beta-testing of the intervention design. Data collected via e-mail and telephone dialogue with the testers.
Measured: 2-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start23 Feb 2018
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, TrygFonden, Denmark
- Responsible party
- Principal investigator, Dorthe Furstrand, Danish Cancer Society
- Investigators
- Anne Tjønneland, MD PhD DMSc, Study director, Danish Cancer Society Research CenterLars Kayser, MD PhD, Study chair, University of Copenhagen, Dept. of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692000
- Sponsor's protocol ID
- DCS-53232017-2
- Acronym
- Emil2
- Status last verified
- Oct 2018
- First submitted
- 29 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is a priority to protect the privacy of participant according to research ethics guidelines and GDPR. Participant data will only be shared in anonymized form and only in the extend demanded by a journal.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03692000
- Acronym / sponsor ID
- Emil2 / DCS-53232017-2
- Conditions
- Health Literacy, Computer Literacy, Prostate Cancer
- Keywords
- eHealth Literacy, Health Literacy, Computer Literacy, Software Design, Healthy Lifestyle, Health Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- University of Copenhagen, TrygFonden, Denmark
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this user-driven study, the methods will be workshops, interviews, usability testing and a concluding proof of concept testing.
Workshops constitutes the bigger part of the user-driven design and ideation in this project. In workshops a group of people will generate a synergy that opens up for new ideas in a framed setting. The workshop format uses methods such as affinity diagrams; innovation jams; and ideation guided through artefacts such as Lego or paper cuts, with the researcher as the facilitator. After analysing the outcome of each design iteration, the findings will be incorporated into the design and focus the planning of the succeeding workshops in an iterative process.
The usability of the design will be tested in between workshops in interviews. The test will be performed by think aloud testing with the current prototype, recording for data collection and researchers in the room to observe, facilitate and probe for reflection.
For a more elaborate usability testing to conclude the design phase, a proof of concept will be performed. In this living lab scenario, the tool will be used at home by end-users in the intended way. Issues with technical functionality, user interphase, data management and workflow will surface and can be corrected during the proof of concept, thus consolidating the service before the feasibility study. Data collection from this part of the study will be by ongoing dialogue with participants, by e-mail and telephone.
To provide the broadest possible foundation for recruitment in terms of diversity in lifestyle and socioeconomic status, invitation to the study is done by mail directly to a randomly chosen group of men with prostate cancer.
All iterations will be based on the results of the previous. The first iteration is based on the ethnographic input from the first study.
All participants in study 2 will be met with a baseline questionnaire to evaluate digital readiness and e-health literacy and adjust participant configuration to ensure diversity. The questionnaire include self-reported educational level, health issues, treatments, diet, physical activity level and other lifestyle factors as well as eHLQ as part of the READHY questionnaire toolkit. The 13 dimensions of READHY comes from heiQ, HLQ and eHLQ, and work as a multidimensional validated robust psychometric instrument evaluation and can be used in combination to describe user's health technology readiness level and degree of enablement.
Each activity of the user-driven design process will be documented in a report, that will serve as the data foundation for a scientific publication.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with a history of prostate cancer | – | –Men with a history of prostate cancer invited to participate in design-workshops , interviews or usabilitytesting. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Danish population
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Digital health service intervention design
Time frame: 5 months. Each iteration of workshops and interviews evaluated to inform the next. Data evaluation points each month.
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.
3 secondary outcomes
Identification of digital capabilities and attitude of men with prostate cancer, in their everyday life
Time frame: 5 months.
Wireframe and mockup
Time frame: 3 months
Beta-test
Time frame: 2-5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: Undecided. It is a priority to protect the privacy of participant according to research ethics guidelines and GDPR. Participant data will only be shared in anonymized form and only in the extend demanded by a journal.
Related trials for Health Literacy
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Tjønneland, MD PhD DMSc study director
Danish Cancer Society Research Center
Lars Kayser, MD PhD study chair
University of Copenhagen, Dept. of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Literacy and Computer Literacy, run by Danish Cancer Society at 1 site in Denmark.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Oct 2018. 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 Denmark. 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?
Results are not available in the source record.
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?
Digital health service intervention design (time frame: 5 months. Each iteration of workshops and interviews evaluated to inform the next. Data evaluation points each month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2018.