Health Related Quality of Life Following Hepatectomy for Colorectal Liver Metastasis: Global and … (NCT02399995) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Health Related Quality of Life Following Hepatectomy for Colorectal Liver Metastasis: Global and Disease Specific Changes Over Time
United States219 participantsStarted 2015-03
Plain-language summary
This study is being done to learn more about health related quality of life factors in people having surgery for colorectal liver metastasis. The investigators will look at how these factors may change over time. The information gained from this study will help the investigators to understand the long-term effects that cancer treatments have on the health related quality of life of patients. This information is of high value and will help doctors talk to patients about the possible effects of their operations. While many patients live a long time after such operations, the studies that have been done do not tell the full story of what patients go through after surgery. This study will help us to understand cancer treatment from the patient's perspective. It will also help cancer patients make better decisions about their treatment options and will help them know what to expect after the operation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of Colorectal cancer liver metastases (CRLM)
* \> 18 years of age
* Absence of unresectable extrahepatic disease
* No previous liver surgery for CRLM
* Clinical risk score (CRS) \>/= 3 or \> 4 tumors
* CRS includes the following variables;
* Lymph node positive primary
* Disease free interval \<12 months
* CEA level \>200ng/mL (highest CEA level within 6 months prior to surgery, not including day of surgery)
* Tumor size \> 5cm
* Number of tumors \>1(based on most recent scan or pathology before liver resection)
* Each variable is given a score of one and summed to give final CRS
* Clinical risk score (CRS) \< 3 with pending variables that cannot be determined preoperatively
* If CRS is still \< 3 postoperatively, these patients will be excluded and replaced (inevaluable).
* Ability to read and write in English
* Undergoing liver resection/ ablation for CRLM
* Underwent liver resection/ ablation for CRLM, but not their primary tumors
Exclusion Criteria:
* Non-English speaking
* Inability to read and/or write
* International Patients
* Concurrent malignancy (excluding non-melanoma skin cancers)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.