NCT03095664

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

7 years

First QC Date

March 14, 2017

Last Update Submit

June 29, 2021

Conditions

Endometrium CancerLife StyleObesity

Keywords

lifestyle interventionendometrial cancersurvival

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    mortality after 5 years

    5 years

Secondary Outcomes (13)

  • Change in Quality of life

    0, 6, 12, 24, 26, 48 and 60 months after surgery

  • Change in handgrip strength

    0, 6, 12, 24, 26, 48 and 60 months after surgery

  • Change in functional capacity (30 second stand chair test)

    0, 6, 12, 24, 26, 48 and 60 months after surgery

  • Change in functional capacity (Timed Get Up and Go test)

    0, 6, 12, 24, 26, 48 and 60 months after surgery

  • Change in functional capacity (6 minute walk test)

    0, 6, 12, 24, 26, 48 and 60 months after surgery

  • +8 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Control group will receive usual care (verbal nutritional counseling after surgical treatment, at discharge).

Interventions

Intervention groupBEHAVIORAL

A behavior change program with 4 monthly 90-min sessions about healthy eating and physical activity.

Also known as: Lifestyle intervention counseling program
Intervention group

Eligibility Criteria

Age20 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • endometrial cancer patients undergoing surgical treatment

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brazilian National Cancer Institute

Rio de Janeiro, Rio de Janeiro, 20220-410, Brazil

Location

Related Publications (1)

  • Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.

    PMID: 36971688DERIVED

MeSH Terms

Conditions

Endometrial NeoplasmsObesity

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gabriela V Chaves, PhD

    Brazilian National Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, researcher

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 30, 2017

Study Start

November 1, 2016

Primary Completion

November 1, 2023

Study Completion

November 1, 2025

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)