Health Related Quality of Life Following Hepatectomy for Colorectal Liver Metastasis: Global and Disease Specific Changes Over Time

Study Overview
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Brief Summary
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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.

Official Title
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Health Related Quality of Life Following Hepatectomy for Colorectal Liver Metastasis: Global and Disease Specific Changes Over Time

Conditions
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Colorectal Liver Metastasis

Intervention / Treatment
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* Behavioral: HRQoL questionnaires.


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients following hepatectomy<br> | Behavioral: HRQoL questionnaires.<br>* Questionnaires/Forms to be completed preoperatively in clinic with assistance from research study administrator: Baseline sociodemographic and clinical variable data sheet (RSA) EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS Baseline disease status and treatment assessment questionnaire Questionnaires/Forms to be completed at first postoperative clinic visit: EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS Questionnaires/Forms to be mailed to patients at ± 2 month window at the following time points 6,12,18,24, and 36 months following hepatectomy: EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS Post surgical follow up disease status and treatment assessment questionnaire At 8 weeks following the mailing of the initial questionnaire package if no response has been received, research personnel will attempt to contact participants by phone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the quality of life (QoL) | 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. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Hepatectomy, 15-057