Health Related Quality of Life Following Hepatectomy for Colorectal Liver Metastasis: Global and Disease Specific Changes Over Time
- Conditions
- Colorectal Liver Metastasis
- Interventions
- Behavioral: HRQoL questionnaires.
- Registration Number
- NCT02399995
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 219
- 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
- Non-English speaking
- Inability to read and/or write
- International Patients
- Concurrent malignancy (excluding non-melanoma skin cancers)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients following hepatectomy HRQoL questionnaires. -
- Primary Outcome Measures
Name Time Method changes in the quality of life (QoL) 3 years in patients at high risk of recurrence undergoing hepatectomy to assess health related quality of life (HRQoL) using the EORTC QLQ-C30, QLQ-LMC21 and the EuroQol EQ-5D-5L, in patients at high risk of recurrence undergoing hepatectomy for colorectal liver metastasis and to evaluate global and disease specific changes over time.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Memorial Sloan Kettering Basking Ridge (Consent and Follow up)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent and Follow up)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Consent and Follow up)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Monmouth (Consent and Follow up)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Westchester (Consent and Follow Up)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Nassau (Consent and follow up)
🇺🇸Uniondale, New York, United States