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

April 8, 2024 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

219

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memorial Sloan Kettering Basking Ridge (Consent and Follow up)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Consent and Follow up)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (Consent and Follow up)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack (Consent and Follow up)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester (Consent and Follow Up)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (Consent and follow up)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients scheduled to undergo liver resection who meet the established criteria will be approached for participation in this study during their preoperative visit. Should patients not undergo their liver resection surgery within 30 days of consent they will be excluded and replaced. Patients undergoing a two stage resection will have their time point frozen for up to six months after their initial surgery. If the time before the second stage of their resection exceeds six months, these patients will be excluded and replaced. The time point will restart at the completion of the second time point. If the patient has an incomplete resection without mention of a second stage resection, the patient will be made ineligible, taken off study, and replaced.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients following hepatectomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Michael D'Angelica, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimated)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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