Ignite Creation Date:
2024-05-05 @ 10:31 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01126840
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2010-05-18
Brief Title:
Survivorship in Lynch Syndrome Families
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Cancer Survivorship in Lynch Syndrome Impact on Patients and Families
Status:
COMPLETED
Status Verified Date:
2022-10
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:
Objectives
Specific Aims
1 Researchers will evaluate and compare predictors of health-related quality of life QOL among colorectal cancer CRC survivors who have Lynch syndrome LS with those patients who have sporadic CRC using both quantitative and qualitative methodology
a In both CRC groups researchers will evaluate cancer preventive and health behaviors including lifestyle factors and screening psychosocial factors including mood family functioning coping style anxiety depression and social resources and health care system factors including interactions with health care providers and service utilization
2 Researchers will compare the experience of first-degree relatives FDRs of patients who have LS with that of FDRs of patients who have sporadic CRC using both quantitative and qualitative methodology
a Researchers will evaluate all of the domains listed above as well as anticipatory grief assessment of caregiving responsibilities and fear of cancer in FDRs of patients with LS-related and sporadic CRC
3 Researchers will examine CRC patients from both groups and their FDRs using dyadic analyses in order to evaluate the similarities and differences in their survivorship experience
4 Researchers will evaluate the preventive and health behavior of patients who are non-conclusive for Lynch syndrome and their family members They will examine their screening behavior and will explore how the interaction between the patients and their relatives affects the relatives screening behavior They also will examine how these non conclusive LS patients and their family members perceive their risk for LS-related cancers
Specific Aims
1 Researchers will evaluate and compare predictors of health-related quality of life QOL among colorectal cancer CRC survivors who have Lynch syndrome LS with those patients who have sporadic CRC using both quantitative and qualitative methodology
a In both CRC groups researchers will evaluate cancer preventive and health behaviors including lifestyle factors and screening psychosocial factors including mood family functioning coping style anxiety depression and social resources and health care system factors including interactions with health care providers and service utilization
2 Researchers will compare the experience of first-degree relatives FDRs of patients who have LS with that of FDRs of patients who have sporadic CRC using both quantitative and qualitative methodology
a Researchers will evaluate all of the domains listed above as well as anticipatory grief assessment of caregiving responsibilities and fear of cancer in FDRs of patients with LS-related and sporadic CRC
3 Researchers will examine CRC patients from both groups and their FDRs using dyadic analyses in order to evaluate the similarities and differences in their survivorship experience
4 Researchers will evaluate the preventive and health behavior of patients who are non-conclusive for Lynch syndrome and their family members They will examine their screening behavior and will explore how the interaction between the patients and their relatives affects the relatives screening behavior They also will examine how these non conclusive LS patients and their family members perceive their risk for LS-related cancers
Detailed Description:
Data will be collected primarily using a mailed self-administered questionnaire A subset of the participants who complete the mailed questionnaire will be recontacted and invited to participate in an in-depth semi-structured telephone interview
Qualitative Mailed Questionnaires
Participants will complete a questionnaire that contains questions about your experiences living with colorectal cancer The questionnaire should take 45-60 minutes to complete
Up to 200 colorectal cancer survivors and up to 200 close relatives of colorectal cancer survivors will take part in this portion of the study
Telephone Interviews
In the phone interview you will be asked some questions about your experiences living with colorectal cancer The phone interview should take 30-45 minutes to complete
Up to 30 colorectal cancer survivors and up to 30 close relatives of colorectal cancer survivors will take part in this portion of the study
Qualitative Mailed Questionnaires
Participants will complete a questionnaire that contains questions about your experiences living with colorectal cancer The questionnaire should take 45-60 minutes to complete
Up to 200 colorectal cancer survivors and up to 200 close relatives of colorectal cancer survivors will take part in this portion of the study
Telephone Interviews
In the phone interview you will be asked some questions about your experiences living with colorectal cancer The phone interview should take 30-45 minutes to complete
Up to 30 colorectal cancer survivors and up to 30 close relatives of colorectal cancer survivors will take part in this portion of the study
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 |
|---|---|---|---|
| CA57730 | OTHER_GRANT | NCI | None |