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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 : Unknown
Verified May 2017 by M.D. Anderson Cancer Center.
Recruitment status was:  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

Tracking Information
First Submitted Date August 13, 2014
First Posted Date August 15, 2014
Last Update Posted Date May 31, 2017
Actual Study Start Date July 2014
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2014)
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.
Original Primary Outcome Measures
 (submitted: August 13, 2014)
Effectiveness of Colorectal Cancer (CRC) Surveillance [ Time Frame: 1 day ]
Audio recordings of interviews and focus groups transcribed for data analysis. Transcripts reviewed to identify themes related to participants' and caregiver's priorities regarding surveillance of colorectal cancer.
Change History Complete list of historical versions of study NCT02217865 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer
Official Title Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients of MD Anderson Colorectal Center and their caregivers recruited by study staff.
Condition Colorectal Cancer
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • Colorectal Cancer Participants
    Colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
    Interventions:
    • Behavioral: Interviews - Colorectal Cancer Participants
    • Behavioral: Questionnaire
    • Behavioral: Focus Groups
  • Caregivers of Colorectal Cancer Participants
    Caregivers of colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
    Interventions:
    • Behavioral: Interviews - Colorectal Cancer Participants
    • Behavioral: Focus Groups
    • Behavioral: Interviews - Caregivers of Colorectal Cancer Participants
Publications * Snyder RA, Hu CY, Cuddy A, Francescatti AB, Schumacher JR, Van Loon K, You YN, Kozower BD, Greenberg CC, Schrag D, Venook A, McKellar D, Winchester DP, Chang GJ; Alliance for Clinical Trials in Oncology Network Cancer Surveillance Optimization Working Group. Association Between Intensity of Posttreatment Surveillance Testing and Detection of Recurrence in Patients With Colorectal Cancer. JAMA. 2018 May 22;319(20):2104-2115. doi: 10.1001/jama.2018.5816.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 30, 2017)
220
Original Estimated Enrollment
 (submitted: August 13, 2014)
180
Estimated Study Completion Date July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility 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:

N/A

Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02217865
Other Study ID Numbers PA13-1002
CE13-04-6855 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators
  • 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
PRS Account M.D. Anderson Cancer Center
Verification Date May 2017