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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00262938
First received: December 6, 2005
Last updated: January 17, 2012
Last verified: January 2012
  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:


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Vivian von Gruenigen, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided by Case Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Body Weight
Signs and Symptoms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 28, 2014