Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01558648
First received: March 16, 2012
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

The goal of this study is to evaluate how surgery for esophageal cancer affects the patient's quality of life over time. The investigators hope this study will provide important information that can be used to improve the quality of life of patients with esophageal cancer. This study will also look at how standard tests and information collected from the patients difficulty swallowing can predict the extent of their esophageal cancer before surgery.


Condition Intervention
Esophageal Cancer
Behavioral: Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • short-term pain [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Pain intensity (average of the four pain severity items) measured by BPI at Post-op Days 1 and 3, after epidural removal, at first post-operative clinic visit, at 4 months

  • short -term quality of life (QOL) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    FACT-E score at the post-op visit and at the 4 months


Secondary Outcome Measures:
  • long-term pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Pain intensity assessed by BPI at 8 months, 12 months, 18 months, 24 months (average of the four pain severity items) Presence of symptoms with intensity ≥3, as assessed by the Symptom Assessment Scale at post-op visit, at 4 months visit (adjusted for pre-operative symptom intensity )

  • long time quality of life (QOL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    FACT- E score at 8 months, 12 months, 18 months, 24 months. Presence of symptoms with intensity ≥3, assessed by the Symptom Assessment Scale at 8 months, 12 months, 18 months, 24 months

  • differences in surgical outcomes [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    operative time, estimated blood loss, length of hospital stay, ICU admission rates, ICU days, complication type, rates and severity as determined by the Common Terminology Criteria for Adverse Events (CTCAE) utilized by MSKCC, rate of anastomotic leak, rate of anastomotic stricture, 90-day (post-operative) hospital readmission rates, time to oral intake, and time to first ambulation.

  • Complications [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    operative time, estimated blood loss, length of hospital stay, ICU admission rates, ICU days, complication type, rates and severity as determined by the Common Terminology Criteria for Adverse Events (CTCAE) utilized by MSKCC, rate of anastomotic leak, rate of anastomotic stricture, 90-day (post-operative) hospital readmission rates, time to oral intake, and time to first ambulation.


Other Outcome Measures:
  • predict EUS T3/T4/stricture disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate whether a combination of a dysphagia score of 2-4 and a specific CT scan maximal tumor thickness. the patient's CT scan (either performed elsewhere or at MSK) will be reviewed by one radiologist, who will assess the maximal thickness of tumor involvement (>=cm). Patients will then undergo their planned a staging Endoscopic ultrasonography (EUS) by the gastroenterology service, at which time the EUS depth of invasion will be assigned. The dysphagia score and CT thickness will then be compared to the EUS depth (considered the 'gold standard')

  • predict EUS T3/T4/stricture or earlier EUS disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    the patient's CT scan (either performed elsewhere or at MSK) will be reviewed by one radiologist, who will assess the maximal thickness of tumor involvement (>=cm). Patients will then undergo their planned staging Endoscopic ultrasonography (EUS) by the gastroenterology service, at which time the EUS depth of invasion will be assigned. The dysphagia score and CT thickness will then be compared to the EUS depth (considered the 'gold standard')


Estimated Enrollment: 265
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pts having Minimally Invasive esophagectomy
This is a prospective non-randomized study comprising two surgical cohorts of esophageal cancer patients. Patients will be assigned to each of the two intervention groups, MIE versus OE, based on a combination of patient referral patterns, patient preference, and surgeon preference/expertise.
Behavioral: Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log
Initial pre-operative assessment post-operative assessment in-hospital assessment at first post-operative visit (clinic visits, or by telephone or mail) assessments at 4, 8, 12, 18, and 24 months post-operatively (+/- 2 month window). For patients who have their surgery delayed, they may be asked to complete another, more updated set of pre-surgery surveys. For the dysphagia score and CT Scan vs EUS subset will be a dysphagia questionnaire, administered at the time of the initial clinic visit.
Pts having open esophagectomy
This is a prospective non-randomized study comprising two surgical cohorts of esophageal cancer patients. Patients will be assigned to each of the two intervention groups, MIE versus OE, based on a combination of patient referral patterns, patient preference, and surgeon preference/expertise.
Behavioral: Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log
Initial pre-operative assessment post-operative assessment in-hospital assessment at first post-operative visit (clinic visits, or by telephone or mail) assessments at 4, 8, 12, 18, and 24 months post-operatively (+/- 2 month window). For patients who have their surgery delayed, they may be asked to complete another, more updated set of pre-surgery surveys. For the dysphagia score and CT Scan vs EUS subset will be a dysphagia questionnaire, administered at the time of the initial clinic visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from the Thoracic Surgery clinics.

Criteria

Inclusion Criteria:

  • Age 18 or older
  • Diagnosis of esophageal cancer, stages I-IIIC, with no prior esophageal resection. Neoadjuvant therapy given prior to presentation at MSKCC will be accepted.
  • Anticipated to undergo surgical resection (Ivor Lewis, Trans Hiatal, thoracoabdominal, or McKeown procedure) of esophageal cancer either by open or minimally invasive methods
  • Chest and abdomen CT scan
  • Ability to speak read and write English.

Exclusion Criteria:

  • Inability to give informed consent
  • Patients requiring a laryngectomy or colon interposition as part of their surgical resection.
  • Patients with scleroderma.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558648

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Nabil Rizk, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01558648     History of Changes
Other Study ID Numbers: 12-003
Study First Received: March 16, 2012
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Minimally Invasive Esophagectomy
Open Esophagectomy
Quality of Life
12-003

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014