Prostate CancerEMILNCT03692585
Ethnographic Study of the Everyday Life of Men With Prostate Cancer, Focusing on Diet, Activities and Digital Behavior
An observational study of Prostate Cancer and Computer Literacy, run by Danish Cancer Society.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer, Computer Literacy, Health Behavior
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Apr 2016
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The Danish Population
Who may be able to join
- Men with a history of prostate cancer, self-reported
Who cannot join
- 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.
About this study
Official title: Digitally Supporting Lifestyle Changes in Men With Prostate Cancer, Based on Characteristics and Needs - Part 1: Ethnographic Study of the Everyday Life of Men With Prostate Cancer, Focusing on Diet, Activities and Digital Behavior
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.
Read the detailed description
Data was collected between June 2015 and April 2016. The data set included 4 parts; introducing interviews, participant observation, concluding interviews and questionnaires.
The introducing interview is conducted as a semi-structured interview with an interview guide. An informal approach is chosen to help along the report needed for the participant observation. The interview is recorded.
During participant observations, the participant is accompanied by the researcher, as he goes about his daily life. The researcher is participating in his activities to the extend it is possible, carrying out spontaneous informal interviews along the way taking cues from the situation, as is inherent to the participation of the researcher during participant observations. Field jottings are done discretely, during breaks in the observation or afterwards, on dictaphone or computer, in order to keep the relation informal, and not redirect the attention to the fact that they were being observed.
The concluding interview is performed as a natural ending of the collaboration between researcher and participant. It is performed as a semi-structured interview with an interview guide, and the central point is to confirm and elaborate on findings of the observation. The interview is recorded.
Pictures are taken of relevant artefacts or sceneries through all visits between participant and researcher, with the consent of the participants. Pictures are a part of the dataset on equal terms with observational notes and interview transcriptions.
In the questionnaire, baseline information such as educational level and self-rated health is gathered along with measurement of eHealth literacy (eHLQ) and health literacy (HLQ), both multidimensional validated psychometric instruments with seven and nine dimensions respectively, in order to relate the demography of this first study to the later studies of the emil project. The questionnaire is not used in the analysis of this study.
All data is collected before beginning familiarization and analysis of data.
Data analysis and interpretation The data set is analyzed using an inductive thematic analysis as described by Braun and Clarke (2006). All interviews and observations are conducted by the first author. Interviews, both introducing and concluding, are transcribed verbatim except for parts not included in the dataset, such as parts where the formal information about the study is given and written consent obtained or parts where practical arrangements are made.
All observational data are written together in one document from each visit. All pictures are included in the dataset. Familiarization with the data will be by listening and relistenning, reading and rereading through the dataset.
The thematic analysis will be performed by coding, processing and interpretation of data using the qualitative research software Nvivo11. Codes are re-read, discussed in the research group, re-coded and themed as outlined by the phases of Braun and Clarke, ending up with a thematic map.
- Conditions
- Prostate Cancer, Computer Literacy, Health Behavior
- Keywords
- Ethnography, Health Informatics, Healthy Lifestyle, Patient Involvement, eHealth Literacy
- Medical subject headings
- Prostatic Neoplasms, Health Behavior, Patient Participation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data collection: 11 months
Secondary outcomes (2)
Identification of digital capabilities and attitude of men with prostate cancer, in their everyday life
Digital capabilities and attitude will be examined as a specific part of the 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.
Measured: Data collection: 11 months
eHealth literacy evaluation
eHealth literacy evaluated by use of the eHealth Literacy questionnaire (eHLQ) and findings related to observed digital behavior.
Measured: Data collection: 11 months
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 startJun 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- 10 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
- NCT03692585
- Sponsor's protocol ID
- DCS-53232017-1
- Other IDs
- Tryg-7-12-0736
- Acronym
- EMIL
- Status last verified
- Sep 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, Based on Characteristics and Needs - Part 1: Ethnographic Study of the Everyday Life of Men With Prostate Cancer, Focusing on Diet, Activities and Digital Behavior
- ClinicalTrials.gov ID
- NCT03692585
- Acronym / sponsor ID
- EMIL / DCS-53232017-1
- Conditions
- Prostate Cancer, Computer Literacy, Health Behavior
- Keywords
- Ethnography, Health Informatics, Healthy Lifestyle, Patient Involvement, eHealth Literacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- University of Copenhagen, TrygFonden, Denmark
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- 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.
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.
Detailed description
Data was collected between June 2015 and April 2016. The data set included 4 parts; introducing interviews, participant observation, concluding interviews and questionnaires.
The introducing interview is conducted as a semi-structured interview with an interview guide. An informal approach is chosen to help along the report needed for the participant observation. The interview is recorded.
During participant observations, the participant is accompanied by the researcher, as he goes about his daily life. The researcher is participating in his activities to the extend it is possible, carrying out spontaneous informal interviews along the way taking cues from the situation, as is inherent to the participation of the researcher during participant observations. Field jottings are done discretely, during breaks in the observation or afterwards, on dictaphone or computer, in order to keep the relation informal, and not redirect the attention to the fact that they were being observed.
The concluding interview is performed as a natural ending of the collaboration between researcher and participant. It is performed as a semi-structured interview with an interview guide, and the central point is to confirm and elaborate on findings of the observation. The interview is recorded.
Pictures are taken of relevant artefacts or sceneries through all visits between participant and researcher, with the consent of the participants. Pictures are a part of the dataset on equal terms with observational notes and interview transcriptions.
In the questionnaire, baseline information such as educational level and self-rated health is gathered along with measurement of eHealth literacy (eHLQ) and health literacy (HLQ), both multidimensional validated psychometric instruments with seven and nine dimensions respectively, in order to relate the demography of this first study to the later studies of the emil project. The questionnaire is not used in the analysis of this study.
All data is collected before beginning familiarization and analysis of data.
Data analysis and interpretation The data set is analyzed using an inductive thematic analysis as described by Braun and Clarke (2006). All interviews and observations are conducted by the first author. Interviews, both introducing and concluding, are transcribed verbatim except for parts not included in the dataset, such as parts where the formal information about the study is given and written consent obtained or parts where practical arrangements are made.
All observational data are written together in one document from each visit. All pictures are included in the dataset. Familiarization with the data will be by listening and relistenning, reading and rereading through the dataset.
The thematic analysis will be performed by coding, processing and interpretation of data using the qualitative research software Nvivo11. Codes are re-read, discussed in the research group, re-coded and themed as outlined by the phases of Braun and Clarke, ending up with a thematic map.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Danish Population
Key inclusion criteria (1 listed)
- Men with a history of prostate cancer, self-reported
Key exclusion criteria (1 listed)
- 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.
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
Identification of factors that influence healthy lifestyle practices related to diet and physical activity for men with prostate cancer, in their everyday life
Time frame: Data collection: 11 months
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.
2 secondary outcomes
Identification of digital capabilities and attitude of men with prostate cancer, in their everyday life
Time frame: Data collection: 11 months
eHealth literacy evaluation
Time frame: Data collection: 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Computer Literacy, run by Danish Cancer Society.
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 1 inclusion and 1 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Identification of factors that influence healthy lifestyle practices related to diet and physical activity for men with prostate cancer, in their everyday life (time frame: Data collection: 11 months). 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.