The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis
NCT ID: NCT02836535
Last Updated: 2017-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
9 participants
OBSERVATIONAL
2016-07-31
2017-06-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
qualitative interviews
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.
qualitative interviews
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
qualitative interviews
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Larissa Temple, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Memorial Sloan Kettering Cancer Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16-940
Identifier Type: -
Identifier Source: org_study_id