Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Endometrial Cancer; Weight Changes

Treatments: Other: educational intervention; Other: preventative dietary intervention; Other: counseling intervention; Behavioral: behavioral dietary intervention; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT00262938

CASE5804

Details and patient eligibility

About

RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably.

PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary counseling on weight loss and quality of life of obese patients with stage I or stage II endometrial cancer in remission.

Full description

OBJECTIVES:

Primary

• Determine the combined effect of exercise and dietary counseling on the weight loss and quality of life of obese patients with stage I or II endometrial cancer in remission.

Secondary

• Determine the feasibility and acceptability of lifestyle interventions in these patients.

OUTLINE: This is a randomized, controlled study. Patients are stratified according to age and body mass index (25-29.9 vs ≥ 30). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
• Arm II: Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.

After completion of study treatment, patients are followed at 1 year.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

Enrollment: 47 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed endometrial cancer meeting the following criteria:

  • Stage I or II disease
  • Post-operative total abdominal hysterectomy and bilateral salpingo-oophorectomy
  • Disease in remission

• Body Mass Index (BMI) ≥ 25

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

PRIOR CONCURRENT THERAPY: Not specified

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Lifestyle counseling

Active Comparator group

Description:

Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling.Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.

Treatment:

Procedure: quality-of-life assessment

Other: counseling intervention

Behavioral: behavioral dietary intervention

Other: preventative dietary intervention

Other: educational intervention

Without Counseling

Active Comparator group

Description:

Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.

Treatment:

Procedure: quality-of-life assessment