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The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836535
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Colorectal Cancer Behavioral: qualitative interviews

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis
Study Start Date : July 2016
Actual Primary Completion Date : June 28, 2017
Actual Study Completion Date : June 28, 2017

Group/Cohort Intervention/treatment
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
Behavioral: 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.
Behavioral: qualitative interviews



Primary Outcome Measures :
  1. Number of complications [ Time Frame: within 90 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at MSK
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

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): NCT02836535


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Larissa Temple, MD, MSc Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02836535    
Other Study ID Numbers: 16-940
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: August 2016
Keywords provided by Memorial Sloan Kettering Cancer Center:
complications
surgery
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases