Clinical trial NCT02399995: Health Related Quality of Life Following Hepatectomy for Colorectal Liver Metastasis: Global and Disease Specific Changes Over Time
Official title: Health Related Quality of Life Following Hepatectomy for Colorectal Liver Metastasis: Global and Disease Specific Changes Over Time
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Liver Metastasis
Keywords: Quality of Life
Hepatectomy
15-057
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: changes in the quality of life (QoL)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent and Follow up)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and Follow up)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and Follow up)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent and Follow up)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent and Follow Up)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent and follow up)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael D'Angelica, MD
role: PRINCIPAL_INVESTIGATOR
References: