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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: qualitative interviews

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients at MSK

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Larissa Temple, MD, MSc, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): June 28, 2017
• Study Completion (Actual): June 28, 2017

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: surgery; complications
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 16-940