Ignite Creation Date:
2024-05-06 @ 12:45 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03836794
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2019-01-24
Brief Title:
Does Geography and Place of Residence Affect Cancer Care An Interview Study
Sponsor:
University of Aberdeen
Organization:
University of Aberdeen
Study Overview
Official Title:
Does Geography and Place of Residence Affect Cancer Care An Interview Study
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is existing evidence that rural cancer patients tend to have worse survival outcomes Potential reasons include differences in endurance of coping with illness different attitudes about illness the nature of rural lifestyles and poorer access to healthcare services Some of these factors may affect their delay in presentation of cancer andor delay in seeking treatment in a timely manner Differences in health outcomes between urban and rural populations have been described in a number of health conditions and to date survivalhealth outcomes related to cancer have been the most extensively researched Rurality has been associated with negative impacts on cancer outcomes in studies from the United Kingdom and elsewhere However as with rural health disadvantage overall the underlying causes are uncertain There is some evidence that rural populations are less likely to engage with screening services and receive lower rates of chemotherapy and surgery If restricted access to services was the major determinant of poorer cancer outcomes for rural populations this should also be reflected in longer delays to diagnosis and treatment for cancer for those patients living more remotely However a recent study from the Northeast of Scotland contradicts this finding that rural patients in Scotland were diagnosed and treated for their cancers quicker than their urban counterparts but died earlier The investigators proposed research aims to provide insights into differences between how urban and rural patients engage with health services in National Health Service NHS Grampian by interviewing patients about their diagnostic pathway their interactions with the healthcare service their treatment choices and how these may have been influenced by where they live
Detailed Description:
A review of literature and data analysis within the Northeast Aberdeen Scotland Cancer and Residence NASCAR database has established that although rural patients are diagnosed and treated much more quickly than their urban counterparts they are significantly more likely to die in the first year after diagnosis At times it was found that patients voluntarily opted out of certain recommended regimens such as radiotherapy simply due to the burden of travel Currently literature only proposes themes such as stoicism attitudes the nature of rural lifestyles and access to healthcare services but nothing is explicitly defined Rural living may influence healthcare interaction at multiple levels and the potentially complex effect on cancer outcomes is best addressed through qualitative research with both urban and rural patients Qualitative enquiries are most likely to give insights into potential mechanisms of urbanrural inequality within Northeast Scotland beyond
The Social Ecological Model SEM is a theory-based framework for understanding the multifaceted and interactive effects of personal and environmental factors that determine behaviours and for identifying behavioural and organisational leverage points and intermediaries for health promotion within organisations 9 This model includes several nested levels individual interpersonal community organisational and policy When addressing any health issue it is important to assess how every level influences one another In our systematic literature review the investigators found that the SEM provided an explanatory framework through which to explore potential inequalities in urban and rural cancer outcomes Within interviews the investigators will use the theoretical framework to prompt participants
Phase 1 Identifying eligible patients and recruitment Patients will be recruited from two sources First those from rural areas and residing at the CLAN House residence Westburn Road Aberdeen during an episode of hospital-based cancer care will be approached by CLAN staff on behalf of the researchers Second patients attending oncology clinic D at Aberdeen Royal Infirmary will be approached by clinic staff on behalf of researchers Interested patients will be directed to the researcher provided the Patient Information Sheet from ClanARI staff to obtain more information about the study and be invited to complete the consent process
Phase 2 Interviews with consented cancer patients Consenting research participants will be interviewed on a single occasion by Miss Carriere using a semi-structured approach Interviews will be digitally audio recorded with permission from the participant The interview will take approximately 45 minutes The interview will happen at a place of the participants own choosing such as within the University of Aberdeen Clinic D - Aberdeen Royal Infirmary ARI or CLAN locations There will also be an option to conduct telephone interviews which will last approximately 45 minutes
Phase 3 Transcribing data from interviews and coding them appropriately Miss Carriere or NJC Secretarial who is a member of university staff in Academic Primary Care will transcribe all interviews after they occur and which is an approved third party organisation for transcribing such work Miss Carriere will also utilise a Contact Sheet to record impressions of the participant not picked up by audio-recorded data Miles and Huberman This will take up to 6 months to complete and analyse Participant interviews will be transcribed verbatim for analysis Framework analysis using components of the socio-ecological model a coding framework of the main themes and sub themes will be established 9 NVivo version 12 software will be used to assist with the management of the data A sample of manuscripts will be coded by a second researcher to ensure validity
Phase 4 Disseminate information gathered from interviews Study results will be collated in the form of a manuscript and further expanded in a PhD thesis At the time of the interview participants will be asked to if they would like to receive a copy of their manuscript Before publication of the manuscript any participants requesting to be kept informed of results will be emailed a copy of the final study report or a lay summary of the results will be published and available
Data Management Digital audio-recordings will be transcribed by Miss Carriere or transcribed by NJC Secretarial and all data will be anonymised by Miss Carriere according to unique participant identification codes NJC Secretarial will receive a copy of the audio recorded files with only the anonymous study ID number via secure file transfer service ZendTo hosted by University of Aberdeen NJC Secretarial will transcribe this data sending the transcription back to Romi Carriere via Zend to Audio recordings would then be deleted by NJC Secretarial Transcripts will be imported into NVivo version 12 and each participant will be assigned a Study ID that will de-identify their private information This study ID will be stored separately from the other data and will only be accessed by the research team Data will be securely stored within and excel file within a secure server andor locked cabinet in the Institute of Applied Health Sciences at the University of Aberdeen All study documentation will be kept for at least 10 years after publication of the study data in accordance with the sponsors archiving Standard Operating Procedure SOP
The Social Ecological Model SEM is a theory-based framework for understanding the multifaceted and interactive effects of personal and environmental factors that determine behaviours and for identifying behavioural and organisational leverage points and intermediaries for health promotion within organisations 9 This model includes several nested levels individual interpersonal community organisational and policy When addressing any health issue it is important to assess how every level influences one another In our systematic literature review the investigators found that the SEM provided an explanatory framework through which to explore potential inequalities in urban and rural cancer outcomes Within interviews the investigators will use the theoretical framework to prompt participants
Phase 1 Identifying eligible patients and recruitment Patients will be recruited from two sources First those from rural areas and residing at the CLAN House residence Westburn Road Aberdeen during an episode of hospital-based cancer care will be approached by CLAN staff on behalf of the researchers Second patients attending oncology clinic D at Aberdeen Royal Infirmary will be approached by clinic staff on behalf of researchers Interested patients will be directed to the researcher provided the Patient Information Sheet from ClanARI staff to obtain more information about the study and be invited to complete the consent process
Phase 2 Interviews with consented cancer patients Consenting research participants will be interviewed on a single occasion by Miss Carriere using a semi-structured approach Interviews will be digitally audio recorded with permission from the participant The interview will take approximately 45 minutes The interview will happen at a place of the participants own choosing such as within the University of Aberdeen Clinic D - Aberdeen Royal Infirmary ARI or CLAN locations There will also be an option to conduct telephone interviews which will last approximately 45 minutes
Phase 3 Transcribing data from interviews and coding them appropriately Miss Carriere or NJC Secretarial who is a member of university staff in Academic Primary Care will transcribe all interviews after they occur and which is an approved third party organisation for transcribing such work Miss Carriere will also utilise a Contact Sheet to record impressions of the participant not picked up by audio-recorded data Miles and Huberman This will take up to 6 months to complete and analyse Participant interviews will be transcribed verbatim for analysis Framework analysis using components of the socio-ecological model a coding framework of the main themes and sub themes will be established 9 NVivo version 12 software will be used to assist with the management of the data A sample of manuscripts will be coded by a second researcher to ensure validity
Phase 4 Disseminate information gathered from interviews Study results will be collated in the form of a manuscript and further expanded in a PhD thesis At the time of the interview participants will be asked to if they would like to receive a copy of their manuscript Before publication of the manuscript any participants requesting to be kept informed of results will be emailed a copy of the final study report or a lay summary of the results will be published and available
Data Management Digital audio-recordings will be transcribed by Miss Carriere or transcribed by NJC Secretarial and all data will be anonymised by Miss Carriere according to unique participant identification codes NJC Secretarial will receive a copy of the audio recorded files with only the anonymous study ID number via secure file transfer service ZendTo hosted by University of Aberdeen NJC Secretarial will transcribe this data sending the transcription back to Romi Carriere via Zend to Audio recordings would then be deleted by NJC Secretarial Transcripts will be imported into NVivo version 12 and each participant will be assigned a Study ID that will de-identify their private information This study ID will be stored separately from the other data and will only be accessed by the research team Data will be securely stored within and excel file within a secure server andor locked cabinet in the Institute of Applied Health Sciences at the University of Aberdeen All study documentation will be kept for at least 10 years after publication of the study data in accordance with the sponsors archiving Standard Operating Procedure SOP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None