The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis
1 other identifier
observational
9
1 country
1
Brief Summary
The purpose of this study is to understand the patient experience with an adverse event after surgery. An adverse event is an undesirable experience or complication associated with your surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2016
Shorter than P25 for all trials
1 active site
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 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 13, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2017
CompletedJune 29, 2017
August 1, 2016
12 months
July 13, 2016
June 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of complications
Information gathered from these interviews will form the basis for the conceptual model of surgical complications. Qualitative data will be obtained from patients who have directly experienced a surgical complication. These complications are defined and categorized by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
within 90 days
Study Arms (2)
patients with complications
Each subject will participate in an audio-recorded interview, either in-person or by telephone, expected to last 30 to 60 minutes. Subjects' responses to the interview questions and basic demographic data will remain confidential. The interview will examine the impact of complications utilizing a semi-structured script specific to each group
patients without Complications (control group)
Each subject will participate in an audio-recorded interview, either in-person or by telephone, expected to last 30 to 60 minutes. Subjects' responses to the interview questions and basic demographic data will remain confidential.
Interventions
Eligibility Criteria
Patients at MSK
You may qualify if:
- Age 18 or older
- Patients who had elective surgery for a primary colorectal cancer within the last 90 days.
- Patients who either:
- Develop an eligible complication (Appendix 1) within 30 days of surgery (n = 25 - 30)
- Do not develop any complication after surgery (n = 25 - 30)
You may not qualify if:
- Multivisceral resections
- Metastatic or locally-recurrent disease
- Physical impairment that may prevent participation in an interview or survey setting
- Active psychiatric illness, cognitive or sensory impairment
- Inability to speak or understand English
- Refusal to participate in an audio-recorded interview
- Inability to participate in an audio-recorded interview for reasons not otherwise specified
- Any second surgical procedure unrelated to the complication within the 90-day period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Larissa Temple, MD, MSc
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2016
First Posted
July 19, 2016
Study Start
July 1, 2016
Primary Completion
June 28, 2017
Study Completion
June 28, 2017
Last Updated
June 29, 2017
Record last verified: 2016-08