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

Colorectal Liver Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02399995
• Other study ID #: 15-057
• Status: Active, not recruiting
• Start date: March 2015
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 219
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent and Follow up)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (Consent and Follow up)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent and Follow Up)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent and Follow up)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent and Follow up)	Montvale	New Jersey
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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center