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

Purpose

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.

Condition	Intervention
Endometrial Cancer Weight Changes	Behavioral: behavioral dietary intervention Other: counseling intervention Other: educational intervention Other: preventative dietary intervention Procedure: quality-of-life assessment

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors

Resource links provided by NLM:

MedlinePlus related topics: Benign Tumors Cancer Exercise and Physical Fitness Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

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 [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]

Enrollment:	47
Study Start Date:	February 2005
Study Completion Date:	August 2011
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Lifestyle counseling 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.	Behavioral: behavioral dietary intervention 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. Other: counseling intervention 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. Other: educational intervention 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. Other: preventative dietary intervention 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. Procedure: quality-of-life assessment Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
Active Comparator: Without Counseling Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.	Procedure: quality-of-life assessment Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.

Arms

Assigned Interventions

Active Comparator: Lifestyle counseling

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.

Behavioral: behavioral dietary intervention

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.

Other: counseling intervention

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.

Other: educational intervention

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.

Other: preventative dietary intervention

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.

Procedure: quality-of-life assessment

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

Active Comparator: Without Counseling

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

Procedure: quality-of-life assessment

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262938

Locations

United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5047

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Vivian von Gruenigen, MD

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided by Case Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00262938 History of Changes
Obsolete Identifiers:	NCT00420979
Other Study ID Numbers:	CASE5804, P30CA043703, CASE-5804, 02-05-05
Study First Received:	December 6, 2005
Last Updated:	January 17, 2012
Health Authority:	United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:

stage I endometrial carcinoma
stage II endometrial carcinoma
weight changes

Additional relevant MeSH terms:

Body Weight Changes
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Body Weight
Signs and Symptoms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on June 17, 2013