Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
The objective of the present study is to implement and evaluate the effect of a counseling program to promote healthy eating and practice of physical activity in the nutritional status, quality of life and prognosis of women Type I (endometrioid) endometrial cancer.

Detailed Description
-----------------
Endometrial cancer (EC) is the fifth most commonly diagnosed malignant neoplasm among women worldwide. The incidence of EC is higher in high-income countries, but it has been increasing in low- and middle-income countries. The main risk factors for EC include the presence of comorbidities, such as diabetes mellitus and hypertension, as well as conditions associated with prolonged exposure to estrogens. Obesity is recognized as a major risk factor for many cancers, including EC. Multiple mechanisms related to obesity are probably involved in the carcinogenesis of EC. Among obese women in the postmenopausal period, there is an increase of bioavailable circulating estrogens. These estrogens come from the aromatization of androgens in adipose tissue and from increased circulating estrogens secondary to the reduced synthesis of sex hormone binding globulin (SHBG) in the liver. Insulin resistance, hyperinsulinemia, increased secretion of adipocytokines and pro-inflammatory cytokines may also play a role in the carcinogenesis of EC. Although the incidence of EC is remarkable, insufficient data has addressed the impact of obesity on EC outcomes. Since about 70% of women diagnosed with endometriod EC are obese, the consequences of obesity-related diseases should be taken into account in order to implement strategies to improve survival outcomes among these women. Sedentary lifestyle and physical inactivity also seem to be relevant, and have been identified as predictors of poor prognosis in patients with different types of cancer. However, the role of lifestyle (including eating and social habits and physical activity) on endometrial cancer prognosis has not been assessed prospectively yet. Studies assessing nutritional status and lifestyle before and after EC diagnosis may elucidate whether and when these factors influence clinical outcomes, including long-term survival.

Official Title
-----------------
Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors

Conditions
-----------------
Endometrium Cancer, Life Style, Obesity

Intervention / Treatment
-----------------
* Behavioral: Intervention group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endometrial cancer patients undergoing surgical treatment Exclusion Criteria: previous oncologic treatment cancer stage IV according to the International Federation of Gynecology and Obstetrics (FIGO) patients who report physical activity over 150 minutes/week of moderate or vigorous intensity individuals with decompensated diabetes mellitus or hypertension patients who have a contraindication to physical activity.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>6 months after surgical treatment, women in the experimental group will attend a counseling program to promote healthy eating and physical activity. | Behavioral: Intervention group<br>* A behavior change program with 4 monthly 90-min sessions about healthy eating and physical activity.<br>* Other names: Lifestyle intervention counseling program;|
| No Intervention: Control group<br>Control group will receive usual care (verbal nutritional counseling after surgical treatment, at discharge). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | mortality after 5 years | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life | Change in quality of life assessed by the Quality of Life-30 (QL30) questionaire of the European Organisation for Research and Treatment of Cancer (EORCT) before and 6, 12, 24, 26, 48 and 60 months after surgery. | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Change in handgrip strength | Change in handgrip strength before and 6, 12, 24, 26, 48 and 60 months after surgery. | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Change in functional capacity (30 second stand chair test) | change in functional capacity assessed by 30 second stand chair test before and 6, 12, 24, 26, 48 and 60 months after surgery | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Change in functional capacity (Timed Get Up and Go test) | change in functional capacity assessed by Timed Get Up and Go test before and 6, 12, 24, 26, 48 and 60 months after surgery | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Change in functional capacity (6 minute walk test) | change in functional capacity assessed by 6 minute walk test before and 6, 12, 24, 26, 48 and 60 months after surgery | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Change in Physical activity behaviour | change in physical activity behaviour assessed by The International Physical Activity Questionnaire (IPAQ) before and 6, 12, 24, 26, 48 and 60 months after surgery | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Change in food intake pattern | change in food intake pattern assessed by Food Frequency questionaire before and 6, 12, 24, 26, 48 and 60 months after surgery | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Change in Body composition | change in body composition assessed by bioelectrical impedance before and 6, 12, 24, 26, 48 and 60 months after surgery | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Change in anthropometric status (weight) | change in weight before and 6, 12, 24, 26, 48 and 60 months after surgery | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Change in anthropometric status (body mass index) | change in body mass index before and 6, 12, 24, 26, 48 and 60 months after surgery | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Change in anthropometric status (waist circumference) | change in waist circumference before and 6, 12, 24, 26, 48 and 60 months after surgery | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Change in anthropometric status (hip circumference) | change in hip circumference before and 6, 12, 24, 26, 48 and 60 months after surgery | 0, 6, 12, 24, 26, 48 and 60 months after surgery | 
| Disease-free survival | Disease-free survival after 5 years | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lifestyle intervention, endometrial cancer, survival