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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2026-03-31

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.

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Detailed Description

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Conditions

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Colorectal Liver Metastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients following hepatectomy

HRQoL questionnaires.

Intervention Type BEHAVIORAL

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.

Interventions

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HRQoL questionnaires.

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.

Intervention Type BEHAVIORAL

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