PSYLIVED: the Psychological Impacts of Living With an Inherited Colorectal Cancer Predisposition Syndrome

NCT06447961 | Recruiting DMC

• 2 other identifiers: RD23/130326731
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Lynch Syndrome; Polyposis Syndrome, Hereditary Mixed, 1; Polyposis Syndrome, Hereditary Mixed, 2

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years.

Secondary Outcomes (2)

• Insight into psychological adaptation

  2 years

• Contribution to patient wellbeing

  2 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adults aged 18 years or older, residing in the UK.
• Diagnosed with inherited colorectal cancer or likely to have inherited colorectal cancer and have been offered genetic testing for this reason.
• Possess the capacity to provide informed consent.
• Able to communicate in English.

You may not qualify if:

• Under 18 years old.
• Unable to communicate in English.
• Experience significant learning or communication difficulties.
• Reside outside of the UK.

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

The St Mark's Centre for Familial Intestinal Cancer

London, NW10 7NS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Polyposis Syndrome, Hereditary Mixed, 1; Polyposis Syndrome, Hereditary Mixed, 2

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Laura Monje-Garcia

CONTACT

0044 20 8453 2656; Laura.monje-garcia@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 7, 2024
• Study Start: June 18, 2024
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

GB (1)