Quality of Life After Esophagectomy for Cancer - Step 2

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01738633

Enrollment

Registered

2012-11-30

Start date

2013-01-31

Completion date

2018-04-30

Last updated

2018-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Quality of Life

Keywords

Esophageal Cancer, Quality of Life

Brief summary

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.

Interventions

BEHAVIORALnutritional counseling

BEHAVIORALrespirology counseling

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026