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Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02217865
Recruitment Status : Recruiting
First Posted : August 15, 2014
Last Update Posted : May 31, 2017
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Alliance for Clinical Trials in Oncology
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The long-term goal of this research is to develop new tools to guide patients, caregivers, and clinicians in making individualized decisions regarding colorectal cancer (CRC) surveillance. As part of a Patient-Centered Outcomes Research Institute-funded contract, investigator will analyze surveillance data to determine the effectiveness of CRC surveillance and recurrence risk taking into account different patient and tumor characteristics; identify key issues about CRC surveillance important to patients, caregivers, and clinicians; and integrate the recurrence risk and patient priorities into a patient-centered, risk stratified surveillance strategy by creating an interactive decision aid for use by patients and clinicians.

This protocol addresses a formative step in the creation of the interactive decision aid where patients' information needs and preferences are assessed regarding decisions about surveillance.

The specific aims of this protocol are:

Phase 1 - To interview patients and their caregivers to determine their concerns, preferences and key priorities regarding surveillance after curative resection of colorectal cancer, and

Phase 2 - To refine the key priorities identified in phase 1 through focus groups and surveys with patients and caregivers.


Condition or disease Intervention/treatment
Colorectal Cancer Behavioral: Interviews - Colorectal Cancer Participants Behavioral: Questionnaire Behavioral: Focus Groups Behavioral: Interviews - Caregivers of Colorectal Cancer Participants

Detailed Description:

You are being asked to take part in this research study which is conducted at The University of Texas MD Anderson ("MD Anderson") and the Harris Health System because you (or someone you act as a caregiver for) are undergoing follow-up after curative resection of colorectal cancer.

The goal of this study is to find out the key priorities for patients and their caregivers when it comes to surveillance after curative resection of colorectal cancer. Your responses will help develop decision aids to help future colorectal cancer patients make more informed decisions about surveillance.

If you agree to participate in this study, you will take part in an interview or focus group in person at MD Anderson, the Harris Health System, or the Alliance. The interview or focus group is expected to take between 30 minutes and 1 hour. The interview or focus group will be audiorecorded. Your name or other identifying information will not appear in the transcript. Adept Word Management, a transcription service that has been approved by the institution, may transcribe the interviews.

You will be asked questions about:

  • your priorities and concerns about colorectal cancer surveillance
  • what you know about colorectal cancer and surveillance,
  • your cancer and treatment (or the patients'),
  • the impact or inconvenience that surveillance causes,
  • who you think should make decisions about surveillance,
  • your thoughts about different surveillance scenarios,
  • and general questions about your age, race, sex, education, and income level.

Information about you will be collected from the medical records and existing data in a database of colorectal patients that is used to organize existing information about colorectal patients to better understand the disease. Information collected will include things like age, gender, marital status, information about the tumor, type of surgery, and what treatment was done before and after surgery. There are no other plans to share your information with others outside the study.

Your participation will be over when the interview is complete. If you are undergoing follow-up for colorectal cancer, research staff will look at your medical record after the interview for information about your cancer including tumor characteristics.

Your participation is completely voluntary. Whether you say yes or no will not change your medical care.

Up to 220 patients and their caregivers will participate in this multicenter study. Up to 190 patients and their caregivers will be enrolled at MD Anderson. Up to 10 patients and their caregivers will be enrolled at the Harris Health System.


Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer
Actual Study Start Date : July 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Colorectal Cancer Participants
Colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
Behavioral: Interviews - Colorectal Cancer Participants
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.

Behavioral: Questionnaire
Questionnaire completion asking general health and demographic questions.
Other Name: Survey

Behavioral: Focus Groups
Focus groups conducted with participants and caregivers. Up to 4 focus groups conducted with up to 30 participants each. Focus groups expected to take 30 to 60 minutes.

Caregivers of Colorectal Cancer Participants
Caregivers of colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
Behavioral: Interviews - Colorectal Cancer Participants
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.

Behavioral: Focus Groups
Focus groups conducted with participants and caregivers. Up to 4 focus groups conducted with up to 30 participants each. Focus groups expected to take 30 to 60 minutes.

Behavioral: Interviews - Caregivers of Colorectal Cancer Participants
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.




Primary Outcome Measures :
  1. Effectiveness of Colorectal Cancer (CRC) Surveillance [ Time Frame: 1 day ]
    Semi-structured interviews and focus groups reviewed to identify themes related to participants' and caregiver's priorities regarding surveillance of colorectal cancer.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients of MD Anderson Colorectal Center and their caregivers recruited by study staff.
Criteria

Inclusion Criteria:

  1. Age 21 or older
  2. Able to read and speak English
  3. Able to undergo a 30 to 60-minute interview or focus group
  4. For phase 1: MD Anderson patient undergoing follow-up for curative resection of stage I-IV colon or rectal cancer OR caregiver of such a patient
  5. For phase 2: Colon or rectal cancer patient

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217865


Contacts
Contact: George J. Chang, MD,MS 713-563-1875

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
United States, Florida
Baptist Medical Group Oncology Recruiting
Pensacola, Florida, United States, 32501
United States, Illinois
The ALLIANCE Recruiting
Chicago, Illinois, United States, 60654
United States, Texas
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Patient-Centered Outcomes Research Institute
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: George J. Chang, MD,MS M.D. Anderson Cancer Center
Principal Investigator: Robert Volk, PHD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02217865     History of Changes
Obsolete Identifiers: NCT02321488
Other Study ID Numbers: PA13-1002
CE13-04-6855 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by M.D. Anderson Cancer Center:
Colorectal Cancer
CRC
Curative resection of colorectal cancer
Caregivers
Interviews
Focus groups
Questionnaires
Surveys

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases