Survivorship in Lynch Syndrome Families

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01126840
First received: May 18, 2010
Last updated: March 31, 2014
Last verified: March 2014

May 18, 2010
March 31, 2014
December 2010
July 2016   (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 ] [ Designated as safety issue: No ]
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. 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.

  2. 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.

  3. 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.
  4. 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.

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.
 
Recruiting
610
Not Provided
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Colorectal cancer (CRC) patients with Lynch-syndrome related CRC: Diagnosis of CRC from 6 months to 5 years prior to enrolling in the study
  2. Colorectal cancer (CRC) patients with sporadic CRC: Diagnosis of CRC from 6 months to 5 years prior to enrolling in the study
  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.

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
  2. FDR's: Personal history of cancer
Both
18 Years and older
Yes
Contact: Susan Peterson, PHD, MPH 713-792-6280
United States
 
NCT01126840
2010-0160, CA57730
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Study Chair: Susan Peterson, PHD, MPH UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP