Quality of Life After Esophagectomy for Cancer – Step 2

Overview

Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care. The study is divided into two steps. This is step 2. At hospital discharge, patients will be randomized into 4 groups receiving respectively: nutritional and respirology counseling; nutritional counseling alone; respirology counseling alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at 1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea), AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.

Full Title of Study: “Quality of Life After Esophagectomy for Cancer – Step 2”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2017

Interventions

  • Behavioral: nutritional counseling
  • Behavioral: respirology counseling

Arms, Groups and Cohorts

  • Experimental: nutritional + respirology counseling
    • patients will receive both nutritional and respirology counseling
  • Experimental: nutritional counseling
    • patients will receive nutritional counseling alone
  • Experimental: respirology counseling
    • patients will receive respirology counseling alone
  • No Intervention: standard care
    • patients will receive standard care

Clinical Trial Outcome Measures

Primary Measures

  • items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
    • Time Frame: 1 month after surgical operation

Secondary Measures

  • item EA (eating) of OES18
    • Time Frame: 1 month after surgical operation
  • items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
    • Time Frame: 3 months after surgical operation
  • item EA (eating) of OES18
    • Time Frame: 3 months after surgical operation

Participating in This Clinical Trial

Inclusion Criteria

  • age above 18 years old – scheduled for esophagectomy for cancer Exclusion Criteria:

  • age below 18 years old – incapability to autonomously fill in questionnaires – primary language not italian

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Padova
  • Collaborator
    • Fondazione Guido Berlucchi
  • Provider of Information About this Clinical Study
    • Sponsor

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