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

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: qualitative interviews

• Registration Number: NCT02836535
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-19
• Status Verified: 2016-08
• Primary Completion: 2017-06-28
• Study Completion: 2017-06-28
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients without Complications (control group)	qualitative interviews	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.
patients with complications	qualitative interviews	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

Primary Outcome Measures

Name	Time	Method
Number of complications	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States