An observational study in Lynch Syndrome, Polyposis Syndrome, Hereditary Mixed, 1 and Polyposis Syndrome, Hereditary Mixed, 2, sponsored by London North West Healthcare NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by London North West Healthcare NHS Trust · Observational
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 Mark's 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.
STUDY SUMMARY
Study Title: Opening Pandora's 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. It's 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:
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.
139 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 58 are open to participants now.
This study's planned enrollment of 66 is below the median of 400 across 59 observational studies indexed under Colorectal Neoplasms, Hereditary Nonpolyposis.
Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →London North West Healthcare NHS Trust is the lead sponsor of 54 studies on the registry; 11 are open to participants now.
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Adults over 18 with an inherited predisposition or likelihood of inheriting colorectal cancer, offered genetic testing (with and without cancer history)
This study population comprises individuals affected by the major inherited colorectal cancer syndromes, specifically focusing on Lynch syndrome and Polyposis syndromes.
Exclusion Criteria:
In-depth understanding of 'lived experiences' of people with or at risk of an inherited colorectal cancer Syndrome
Detailed insights into the emotional responses, cognitive processes, and perceptions of individuals throughout their genetic diagnosis journey, providing a rich understanding of their lived experiences. This is a qualitative study using semi-structured interviews. Data from the qualitative semi-structured interviews will be used to address this outcome. Please note that no score or scale will be used in this research.
Time frame: 2 years.
Insight into psychological adaptation
understanding of how individuals psychologically adapt to the genetic diagnosis over time, identifying patterns of coping, emotional adjustments, and strategies employed to manage the psychological impact. This is a qualitative study using semi-structured interviews. Data from the qualitative semi-structured interviews will be used to address this outcome. Please note that no score or scale will be used in this research.
Time frame: 2 years
Contribution to patient wellbeing
Knowledge that contributes to improved patient care, by identifying psychological stressors, adaptive approaches, and potential areas for intervention, ultimately improving the overall well-being of individuals and families affected by inherited colorectal cancer. This is a qualitative study using semi-structured interviews. Data from the qualitative semi-structured interviews will be used to address this outcome. Please note that no score or scale will be used in this research.
Time frame: 2 years
Plan to share: Undecided
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