Colorectal CancerNCT02836535
The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis
An observational study of Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- qualitative interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 28 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at MSK
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Colorectal Cancer
- Being tested
- qualitative interviews
- Keywords
- complications, surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative interviewsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: qualitative interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion28 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larissa Temple, MD, MSc, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836535
- Sponsor's protocol ID
- 16-940
- Status last verified
- Aug 2016
- First submitted
- 13 Jul 2016
- Last updated
- 29 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis
- ClinicalTrials.gov ID
- NCT02836535
- Acronym / sponsor ID
- 16-940
- Conditions
- Colorectal Cancer
- Keywords
- complications, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with complications | – | Behavioral: qualitative interviewsEach 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 |
| patients without Complications (control group) | – | Behavioral: qualitative interviewsEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at MSK
Key inclusion criteria (5 listed)
- Age 18 or older
- Patients who had elective surgery for a primary colorectal cancer within the last 90 days.
- Patients who either:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qualitative interviews | Behavioural | patients with complications, patients without Complications (control group) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa Temple, MD, MSc principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of complications (time frame: within 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.