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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Colorectal Liver Metastasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Basking Ridge (Consent and Follow up), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HRQoL questionnaires.

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.

Primary outcomes

changes in the quality of life (QoL)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2027
Study completion: 2027
First posted: Mar 26, 2015
Registry last updated: Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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