Clinical trial NCT00262938: Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission
Official title: Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Weight Changes
Keywords: stage I endometrial carcinoma
stage II endometrial carcinoma
weight changes
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2005-12-07
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months
timeFrame: baseline, 3, 6, and 12 months
measure: Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months
timeFrame: baseline, 3, 6, and 12 months
measure: Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36)
timeFrame: baseline, 3, 6, and 12 months
measure: Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months
timeFrame: baseline, 3, 6, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Vivian von Gruenigen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Gruenigen VE, Waggoner SE, Frasure HE, Kavanagh MB, Janata JW, Rose PG, Courneya KS, Lerner E. Lifestyle challenges in endometrial cancer survivorship. Obstet Gynecol. 2011 Jan;117(1):93-100. doi: 10.1097/AOG.0b013e31820205b3.
citation: von Gruenigen VE, Gibbons HE, Kavanagh MB, Janata JW, Lerner E, Courneya KS. A randomized trial of a lifestyle intervention in obese endometrial cancer survivors: quality of life outcomes and mediators of behavior change. Health Qual Life Outcomes. 2009 Feb 25;7:17. doi: 10.1186/1477-7525-7-17.