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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Colorectal Cancer

Treatments: Behavioral: qualitative interviews

Study type: Observational

Funder types: Other

Identifiers

NCT02836535

16-940

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

9 participants in 2 patient groups

patients with complications

Description:

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

Treatment:

Behavioral: qualitative interviews

patients without Complications (control group)

Description:

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.

Treatment:

Behavioral: qualitative interviews