Survivorship in Lynch Syndrome Families
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Purpose
Objectives:
Specific Aims:
We 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, we 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.
We 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. We 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.
- We 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.
- We will evaluate the preventive and health behavior of patients who are non-conclusive for Lynch syndrome and their family members. We will examine their screening behavior and will explore how the interaction between the patients and their relatives affects the relatives' screening behavior. We also will examine how these non conclusive LS patients and their family members perceive their risk for LS-related cancers.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Behavioral: Telephone Interview Behavioral: Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Cancer Survivorship in Lynch Syndrome: Impact on Patients and Families |
- Compare Predictors of Health-Related Quality of Life (QOL) among Colorectal Cancer (CRC) Survivors who have Lynch Syndrome (LS) with patients who have Sporadic CRC [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 610 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Questionnaire + Telephone Interview
Mailed questionnaire that contains questions about experiences living with colorectal cancer, take 45-60 minutes to complete. The phone interview should take 30-45 minutes to complete.
|
Behavioral: Telephone Interview
The phone interview should take 30-45 minutes to complete.
Other Name: Survey
Behavioral: Questionnaire
Mailed questionnaire that contains questions about experiences living with colorectal cancer, take 45-60 minutes to complete.
Other Name: Survey
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Colorectal cancer (CRC) patients with Lynch-syndrome related CRC or with sporadic CRC; along with first-degree relatives (FDRs), Siblings or adult children of recruited CRC patients
Inclusion Criteria:
- Colorectal cancer (CRC) patients with Lynch-syndrome related CRC: Diagnosis of CRC from 6 months to 5 years prior to enrolling in the study
- Colorectal cancer (CRC) patients with sporadic CRC: Diagnosis of CRC from 6 months to 5 years prior to enrolling in the study
- All First-degree relatives (FDRs): Siblings or adult children of recruited CRC patients
- All Participants: 18 years of age or older
- All Participants: Able to read and speak English
- All Participants: Able to be contacted by mail.
Exclusion Criteria:
- CRC patients with sporadic CRC: Personal or family history of Lynch syndrome, familial adenomatous polyposis, inflammatory bowel disease or those who have a FDR with CRC
- FDR's: Personal history of cancer
Contacts and Locations| Contact: Susan Peterson, PHD, MPH | 713-792-6280 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Susan Peterson, PHD, MPH | |
| Study Chair: | Susan Peterson, PHD, MPH | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01126840 History of Changes |
| Other Study ID Numbers: | 2010-0160, CA57730 |
| Study First Received: | May 18, 2010 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Lynch Syndrome Families Quality of life QOL |
First-degree relatives Questionnaire Interview |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013