Clinical trial NCT03692585: Ethnographic Study of the Everyday Life of Men With Prostate Cancer, Focusing on Diet, Activities and Digital Behavior
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Computer Literacy
Health Behavior
Keywords: Ethnography
Health Informatics
Healthy Lifestyle
Patient Involvement
eHealth Literacy
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: TrygFonden, Denmark
First posted: 2018-10-02
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Danish Population

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identification of factors that influence healthy lifestyle practices related to diet and physical activity for men with prostate cancer, in their everyday life
timeFrame: Data collection: 11 months
Secondary outcomes:
measure: Identification of digital capabilities and attitude of men with prostate cancer, in their everyday life
timeFrame: Data collection: 11 months
measure: eHealth literacy evaluation
timeFrame: Data collection: 11 months
Other outcomes:
Locations:
Study officials:
affiliation: Danish Cancer Society Research Center
name: Anne Tjønneland, MD PhD DMSc
role: STUDY_DIRECTOR
affiliation: University of Copenhagen, Dept. of Public Health
name: Lars Kayser, MD PhD
role: STUDY_CHAIR
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