Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447961
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-28
Brief Title:
PSYLIVED the Psychological Impacts of Living With an Inherited Colorectal Cancer Predisposition Syndrome
Sponsor:
London North West Healthcare NHS Trust
Organization:
London North West Healthcare NHS Trust
Study Overview
Official Title:
The Psychological Impacts of Living With an Inherited Colorectal Cancer Predisposition Syndrome
Status:
RECRUITING
Status Verified Date:
2024-06
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:
PSYLIVED
Brief Summary:
Why PSYLIVED is a qualitative study that aims to understand the psychological experience of individuals living with inherited colorectal cancer It addresses the question of how individuals cope emotionally and adapt to the unique challenges they face This research sheds light on the emotional journey of those with inherited colorectal cancer potentially leading to improved support services interventions and care practices tailored to their needs The study seeks to enhance the well-being of patients undergoing genetic testing and contribute to better services and support practices
What PSYLIVED is a qualitative study that will employ reflexive Thematic Analysis methodology to explore the emotional responses and experiences of participants over time
Who The investigators are interested in interviewing between 30 to 66 individuals who have first-hand experience of being at risk or having an inherited colorectal cancer syndrome
Where While the study is conducted by the St Marks Centre for Familial Intestinal Cancer this study is open to individuals in the UK Interviews will primarily be conducted via telephone or Microsoft Teams to facilitate accessibility However participants residing near London who prefer face-to-face interviews will be offered this option
How Each participant will take part in a one-hour audio-recorded interview where they will be asked to talk about their experiences The interview will be recorded so it can be transcribed word by word During the transcription the interview will be anonymised to ensure confidentiality The responses will then be compared and analysed to create a result summary along with interviews from other individuals with similar experiences The study is set to commence in June 2024 with recruitment open for approximately two years
What PSYLIVED is a qualitative study that will employ reflexive Thematic Analysis methodology to explore the emotional responses and experiences of participants over time
Who The investigators are interested in interviewing between 30 to 66 individuals who have first-hand experience of being at risk or having an inherited colorectal cancer syndrome
Where While the study is conducted by the St Marks Centre for Familial Intestinal Cancer this study is open to individuals in the UK Interviews will primarily be conducted via telephone or Microsoft Teams to facilitate accessibility However participants residing near London who prefer face-to-face interviews will be offered this option
How Each participant will take part in a one-hour audio-recorded interview where they will be asked to talk about their experiences The interview will be recorded so it can be transcribed word by word During the transcription the interview will be anonymised to ensure confidentiality The responses will then be compared and analysed to create a result summary along with interviews from other individuals with similar experiences The study is set to commence in June 2024 with recruitment open for approximately two years
Detailed Description:
STUDY SUMMARY
Study Title Opening Pandoras box the Psychological Impacts of living with an inherited colorectal cancer predisposition syndrome Internal ref no or short title PSYLIVED Study Design Qualitative Study Participants Adults over 18 with an inherited predisposition or likelihood of inheriting colorectal cancer offered genetic testing with and without cancer history Planned Size of Sample 30-66 Follow up duration After the initial interview participants will not undergo any follow-up assessments The screening questionnaire will determine the allocated study time-point for analysis Its important to note that this study is not longitudinal
Planned Study Period 2024-2026 Research Question What are the lived experiences and psychological adaptation processes of individuals diagnosed with inherited colorectal cancer over time
PSYLIVED is a qualitative study exploring the psychological experience and long-term adaptation process of people living with inherited colorectal cancer This project will recruit between 30 to 66 participants which will be allocated at one of the 3 time-points of the long-term adaptation process following the Family Systems Genetic Illness Model as articulated by Miller et al in 2006 1 The 3 time-points are
1 Time-point 1 crisis I- pre-testing phase before receiving genetic results
2 Time-point 2 crisis II- post-testing phase generally up 1 year post genetic testing However the team will follow a triageevaluation system
3 Time-point 3 long term adaptation phase generally 1 year post genetic testing and beyond However the research team will use a triageevaluation system This approach will allow for a rich examination of how participants navigate the psychological impact of their genetic diagnosis across varying temporal contexts
Each of the resulting six distinct datasets as outlined in Table 1 will undergo individual analyses dedicated to uncovering the psychological adaptation processes at specific time-points This methodological structure ensures a holistic exploration of the psychological trajectory experienced by individuals living with inherited colorectal cancer
Furthermore each analysis at distinct time-points will be refined by distinguishing between cancer and non-cancer patients Subsequently a synthesis of findings will be conducted through the comparison and combination of individual datasets By generating a series of analytical sets the study aims to provide a comprehensive understanding of the psychological journey undertaken by individuals living with inherited colorectal cancer
Study Title Opening Pandoras box the Psychological Impacts of living with an inherited colorectal cancer predisposition syndrome Internal ref no or short title PSYLIVED Study Design Qualitative Study Participants Adults over 18 with an inherited predisposition or likelihood of inheriting colorectal cancer offered genetic testing with and without cancer history Planned Size of Sample 30-66 Follow up duration After the initial interview participants will not undergo any follow-up assessments The screening questionnaire will determine the allocated study time-point for analysis Its important to note that this study is not longitudinal
Planned Study Period 2024-2026 Research Question What are the lived experiences and psychological adaptation processes of individuals diagnosed with inherited colorectal cancer over time
PSYLIVED is a qualitative study exploring the psychological experience and long-term adaptation process of people living with inherited colorectal cancer This project will recruit between 30 to 66 participants which will be allocated at one of the 3 time-points of the long-term adaptation process following the Family Systems Genetic Illness Model as articulated by Miller et al in 2006 1 The 3 time-points are
1 Time-point 1 crisis I- pre-testing phase before receiving genetic results
2 Time-point 2 crisis II- post-testing phase generally up 1 year post genetic testing However the team will follow a triageevaluation system
3 Time-point 3 long term adaptation phase generally 1 year post genetic testing and beyond However the research team will use a triageevaluation system This approach will allow for a rich examination of how participants navigate the psychological impact of their genetic diagnosis across varying temporal contexts
Each of the resulting six distinct datasets as outlined in Table 1 will undergo individual analyses dedicated to uncovering the psychological adaptation processes at specific time-points This methodological structure ensures a holistic exploration of the psychological trajectory experienced by individuals living with inherited colorectal cancer
Furthermore each analysis at distinct time-points will be refined by distinguishing between cancer and non-cancer patients Subsequently a synthesis of findings will be conducted through the comparison and combination of individual datasets By generating a series of analytical sets the study aims to provide a comprehensive understanding of the psychological journey undertaken by individuals living with inherited colorectal cancer
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 326731 | OTHER | IRAS | None |