- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692585
Ethnographic Study of the Everyday Life of Men With Prostate Cancer, Focusing on Diet, Activities and Digital Behavior (EMIL)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men with a history of prostate cancer, self-reported
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Data collection: 11 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of digital capabilities and attitude of men with prostate cancer, in their everyday life
Time Frame: Data collection: 11 months
|
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.
|
Data collection: 11 months
|
eHealth literacy evaluation
Time Frame: Data collection: 11 months
|
eHealth literacy evaluated by use of the eHealth Literacy questionnaire (eHLQ) and findings related to observed digital behavior.
|
Data collection: 11 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Anne Tjønneland, MD PhD DMSc, Danish Cancer Society Research Center
- Study Chair: Lars Kayser, MD PhD, University of Copenhagen, Dept. of Public Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCS-53232017-1
- Tryg-7-12-0736 (Other Identifier: Trygfonden)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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