NCT03692585

Brief Summary

This is an ethnographic study to investigate the competences and preferences in everyday living of men with prostate cancer, using participant observation and semi-structured interviews. The study will work as the need assessment part of the emil project, which aims to design, develop, implement and evaluate a digital service to support a healthy lifestyle among men with prostate cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

September 29, 2018

Last Update Submit

October 1, 2018

Conditions

Keywords

EthnographyHealth InformaticsHealthy LifestylePatient InvolvementeHealth Literacy

Outcome Measures

Primary Outcomes (1)

  • Identification of factors that influence healthy lifestyle practices related to diet and physical activity for men with prostate cancer, in their everyday life

    Factors will be identified by using Thematic analysis (Braun and Clarke, 2006) of ethnographic data, including interview transcriptions, observational notes, pictures and artefacts from the participant observation. All themes are based on identified categories and coding of observations, and are confirmed by supporting quotes. The primary outcomes will be obtained in a way that it can inform the design process in the second study of the emil-project.

    Data collection: 11 months

Secondary Outcomes (2)

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

    Data collection: 11 months

  • eHealth literacy evaluation

    Data collection: 11 months

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Danish Population

You may qualify if:

  • Men with a history of prostate cancer, self-reported

You may not qualify if:

  • 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. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic NeoplasmsHealth BehaviorPatient Participation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehaviorPatient Acceptance of Health CareTreatment Adherence and Compliance

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
Ph.d. fellow, MD

Study Record Dates

First Submitted

September 29, 2018

First Posted

October 2, 2018

Study Start

June 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

October 2, 2018

Record last verified: 2018-09