An interventional study of nutritional counseling and respirology counseling in Esophageal Cancer and Quality of Life, sponsored by University of Padova. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-23.
Sponsored by University of Padova · Not applicable, Interventional, and Treatment
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.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's enrollment of 80 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients will receive both nutritional and respirology counseling
Behavioral: nutritional counseling · Behavioral: respirology counseling
patients will receive nutritional counseling alone
Behavioral: nutritional counseling
patients will receive respirology counseling alone
Behavioral: respirology counseling
patients will receive standard care
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
Time frame: 1 month after surgical operation
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
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University of Padova