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Survivorship in Lynch Syndrome Families

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01126840
First Posted: May 20, 2010
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
May 18, 2010
May 20, 2010
October 9, 2017
June 20, 2010
June 2019   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01126840 on ClinicalTrials.gov Archive Site
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Survivorship in Lynch Syndrome Families
Cancer Survivorship in Lynch Syndrome: Impact on Patients and Families

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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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
Colorectal Cancer
  • 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
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.
Interventions:
  • Behavioral: Telephone Interview
  • Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
303
June 2019
June 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Colorectal cancer (CRC) patients with Lynch-syndrome related CRC: Diagnosis of CRC
  2. Colorectal cancer (CRC) patients with sporadic CRC: Diagnosis of CRC
  3. All First-degree relatives (FDRs): Siblings or adult children of recruited CRC patients
  4. All Participants: 18 years of age or older
  5. All Participants: Able to read and speak English
  6. All Participants: Able to be contacted by mail.
  7. All Second and Third relatives (SDRs and TDRs): Grandparents, grandchildren, aunts, uncles, nieces, nephews, and first-degree cousins of recruited CRC patients
  8. IPs with a LS MMR mutation who were seen at MDACC for genetic counseling and testing during 2011-2014.

Exclusion Criteria:

1) 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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01126840
2010-0160
CA57730 ( Other Grant/Funding Number: NCI )
No
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Susan Peterson, PHD, MPH M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2017