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
  Purpose

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.

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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 2016 (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
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126840

Contacts
Contact: Susan Peterson, PHD, MPH 713-792-6280

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Susan Peterson, PHD, MPH         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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 31, 2014
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
Syndrome
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014