Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer
2 other identifiers
observational
32
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2014
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2014
CompletedFirst Submitted
Initial submission to the registry
August 13, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2022
CompletedFebruary 15, 2022
February 1, 2022
7.5 years
August 13, 2014
February 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness of Colorectal Cancer (CRC) Surveillance
Semi-structured interviews and focus groups reviewed to identify themes related to participants' and caregiver's priorities regarding surveillance of colorectal cancer.
1 day
Study Arms (2)
Colorectal Cancer Participants
Colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
Caregivers of Colorectal Cancer Participants
Caregivers of colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
Interventions
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.
Questionnaire completion asking general health and demographic questions.
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.
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.
Eligibility Criteria
Patients of MD Anderson Colorectal Center and their caregivers recruited by study staff.
You may qualify if:
- Age 21 or older
- Able to read and speak English
- Able to undergo a 30 to 60-minute interview or focus group
- 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
- For phase 2: Colon or rectal cancer patient
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Patient-Centered Outcomes Research Institutecollaborator
- Alliance for Clinical Trials in Oncologycollaborator
Study Sites (3)
University of California San Francisco
San Francisco, California, 94143, United States
Lyndon B. Johnson General Hospital
Houston, Texas, 77026, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
Zafar SN, Hu CY, Snyder RA, Cuddy A, You YN, Lowenstein LM, Volk RJ, Chang GJ. Predicting Risk of Recurrence After Colorectal Cancer Surgery in the United States: An Analysis of a Special Commission on Cancer National Study. Ann Surg Oncol. 2020 Aug;27(8):2740-2749. doi: 10.1245/s10434-020-08238-7. Epub 2020 Feb 20.
PMID: 32080809DERIVEDSnyder 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.
PMID: 29800181DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
George J. Chang, MD,MS
M.D. Anderson Cancer Center
- PRINCIPAL INVESTIGATOR
Robert Volk, PHD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2014
First Posted
August 15, 2014
Study Start
July 16, 2014
Primary Completion
January 13, 2022
Study Completion
January 13, 2022
Last Updated
February 15, 2022
Record last verified: 2022-02