Effect of Physical Activity Intervention on Overweight and Obese Patients With Endometrial Cancer

NCT06312917CompletedNAINTERVENTIONAL

Summary

This study evaluated the clinical outcome of exercise management on patients with endometrial cancer treated with fertility preservation, including the effect of complete response rate, complete response time, recurrence rate, recurrence time, etc., and physical composition, to evaluate the effectiveness of physical activity on weight management.

Key Facts

Lead Sponsor

Peking University People's Hospital

Enrollment

72

Start Date

2023-08-01

Completion Date

2023-12-30

Study Type

INTERVENTIONAL

Official Title

Effects of Physical Activity Based on the Transtheoretical Model on Patients With Endometrial Cancer Undergoing Fertility-sparing Treatment: a Randomized Controlled Trial

Interventions

Physical activity

Conditions

Endometrium CancerPhysical ActivityWeight Management

Eligibility

Age Range

20 Years – 40 Years

Sex

FEMALE

Inclusion Criteria:

* Participants were patients who met the following predefined eligibility criteria: Ages 20-40; Overweight or obese; The pathological diagnosis was EC (endometrioid, grade I, no myometrium invasion or metastasis). Not pregnant; Be willing to comply with test requirements after being fully informed of all risks and inconveniences associated with the test.

Exclusion Criteria:

* Recurrent or metastatic disease; Currently participating in regular exercise at least 2 days per week; Pregnant at the start of the study; Or unwilling to comply with research requirements. Patients also completed the Physical Activity Readiness Questionnaire (PAR-Q) through a telephone interview. Patients with one or more potential exercise-related safety risks were excluded.

Outcome Measures

Primary Outcomes

Body weight

Body weight measured naked or wearing work clothes of known weight, an electronic weight scale is used to measure

Time frame: Enrollment，four months after the intervention

BMI

Body mass index is a standard commonly used in the world to measure the degree of body fat and whether it is healthy. The formula is BMI= weight ÷ height\*height

Time frame: Enrollment，four months after the intervention

physical activity level

Physical activity energy was calculated using the formula of the International Physical Activity Questionnaire. Calculation Manual: Physical activity amount (MEt-minutes /week)= physical activity intensity MET value × physical activity time (minutes)/ day × activity days.

Time frame: Enrollment，four months after the intervention

Secondary Outcomes

serum total cholesterol

Total cholesterol is the sum of all lipoproteins in the blood.The measurement was made by drawing venous blood. Suitable level for adults: 2.83\~5.20mmol/L(110\~200mg/dl)

Time frame: Enrollment，four months after the intervention

Waist Hip Ratio

It is an indicator of the distribution of human body fat. It is the ratio of the waist and abdomen circumference marked by the umbilicus to the hip circumference marked by the anterior superior spine of the iliac (cm).

Time frame: Enrollment，four months after the intervention

triglyceride

Serum triglyceride determination is a routine item in lipid analysis. The measurement was made by drawing venous blood. Normal reference value of serum triglyceride: 0.45 \~ 1.69mmol/L

Time frame: Enrollment，four months after the intervention

Locations

Peking University People's Hospital, Beijing, China

Linked Papers

Developing a Complex Intervention Plan for Physical Activity in Overweight and Obese Endometrial Cancer Patients: A Multimethod Study

Aims and Objectives This study aims to develop a comprehensive physical activity (PA) intervention tailored for overweight and obese patients with endometrial cancer (EC). It integrates theoretical frameworks, empirical evidence, expert opinions, and stakeholder perspectives to assist clinical providers in implementing standardized PA guidelines. Background Obesity is a significant risk factor for EC and is closely linked to treatment outcomes. Although previous studies have focused on the role of PA in weight loss and survival, they lack detailed, evidence‐based guidance specifically tailored for EC patients. Design and Methods We developed a PA instruction program using the Evidence‐Based Nursing Practice Pathway and the Medical Research Council’s Framework for Complex Interventions. The development process consisted of three phases: a preparatory phase, the development and implementation of evidence‐based interventions, and the refinement of the program through Delphi consultation. Results The program framework was developed using multiple methods, including evidence searches (guidelines and expert consensus), semistructured interviews, and expert consultations. It encompasses preinstruction, implementation methods, and strategies for maintaining PA. Instructional materials such as posters, brochures, videos, and checklists were created to facilitate clinical integration. Conclusions This study is the first to develop a tailored PA program for overweight EC patients. The rigorous design, based on complex intervention frameworks and expert input, has the potential to improve clinical practice, enhance tumor remission rates, and improve fertility outcomes. Relevance to Clinical Practice Utilizing the MRC framework, this study integrated evidence and stakeholder feedback to develop a tailored intervention program. It aims to increase PA among overweight and obese EC patients by providing educational materials for clinicians and patients, thereby promoting its adoption in clinical practice. Trial Registration: ClinicalTrials.gov_identifier: NCT06312917

Linked Investigators

Jianliu Wang

Xiaodan Li

Effect of Physical Activity Intervention on Overweight and Obese Patients With Endometrial Cancer