Lynch SyndromePSYLIVEDNCT06447961
PSYLIVED: the Psychological Impacts of Living With an Inherited Colorectal Cancer Predisposition Syndrome
An observational study of Lynch Syndrome and Polyposis Syndrome, Hereditary Mixed, 1, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Lynch Syndrome, Polyposis Syndrome, Hereditary Mixed, 1, Polyposis Syndrome, Hereditary Mixed, 2
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2024to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Under 18 years old.
- Unable to communicate in English.
- Experience significant learning or communication difficulties.
- Reside outside of the UK.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The St Mark's Centre for Familial Intestinal Cancer
London, NW10 7NS
Laura Monje-Garcia, Laura.monje-garcia@nhs.net
About this study
Official title: The Psychological Impacts of Living With an Inherited Colorectal Cancer Predisposition Syndrome
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.
Read more
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.
Read the detailed description
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:
- Time-point 1: crisis I- pre-testing phase (before receiving genetic results)
- Time-point 2: crisis II- post-testing phase (generally up 1 year post genetic testing. However, the team will follow a triage/evaluation system)
- Time-point 3: long term adaptation phase (generally 1 year post genetic testing and beyond. However, the research team will use a triage/evaluation 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.
- Conditions
- Lynch Syndrome, Polyposis Syndrome, Hereditary Mixed, 1, Polyposis Syndrome, Hereditary Mixed, 2
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Polyposis Syndrome, Hereditary Mixed, 1, Polyposis Syndrome, Hereditary Mixed, 2
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start18 Jun 2024
- Primary completion18 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447961
- Sponsor's protocol ID
- RD23/130
- Other IDs
- 326731
- Acronym
- PSYLIVED
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychological Impacts of Living With an Inherited Colorectal Cancer Predisposition Syndrome
- ClinicalTrials.gov ID
- NCT06447961
- Acronym / sponsor ID
- PSYLIVED / RD23/130
- Conditions
- Lynch Syndrome, Polyposis Syndrome, Hereditary Mixed, 1, Polyposis Syndrome, Hereditary Mixed, 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 18 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Time-point 1: crisis I- pre-testing phase (before receiving genetic results)
- Time-point 2: crisis II- post-testing phase (generally up 1 year post genetic testing. However, the team will follow a triage/evaluation system)
- Time-point 3: long term adaptation phase (generally 1 year post genetic testing and beyond. However, the research team will use a triage/evaluation 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Under 18 years old.
- Unable to communicate in English.
- Experience significant learning or communication difficulties.
- Reside outside of the UK.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-depth understanding of 'lived experiences' of people with or at risk of an inherited colorectal cancer Syndrome
Time frame: 2 years.
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 secondary outcomes
Insight into psychological adaptation
Time frame: 2 years
Contribution to patient wellbeing
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lynch Syndrome and Polyposis Syndrome, Hereditary Mixed, 1, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Monje-Garcia (0044 20 8453 2656, Laura.monje-garcia@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-depth understanding of 'lived experiences' of people with or at risk of an inherited colorectal cancer Syndrome (time frame: 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.