Endometrial CancerNCT00262938
Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission
A study testing behavioral dietary intervention, counseling intervention and educational intervention in people with Endometrial Cancer and Weight Changes, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Endometrial Cancer, Weight Changes
- What is being tested?
- behavioral dietary intervention, counseling intervention and educational intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5047
About this study
Official title: Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors
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.
Read the 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.
- Conditions
- Endometrial Cancer, Weight Changes
- Being tested
- behavioral dietary intervention, counseling intervention, educational intervention, preventative dietary intervention, quality-of-life assessment
- Keywords
- stage I endometrial carcinoma, stage II endometrial carcinoma, weight changes
- Medical subject headings
- Endometrial Neoplasms, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral dietary interventionBehavioural
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.
counseling interventionOther
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.
educational interventionOther
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.
preventative dietary interventionOther
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.
quality-of-life assessmentProcedure or surgery
Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Active comparator | 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. Receives: Behavioral: behavioral dietary intervention; Other: counseling intervention; Other: educational intervention; Other: preventative dietary intervention; Procedure: quality-of-life assessment |
| Without Counseling | Active comparator | Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months. Receives: Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 3, 6, and 12 months
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
Measured: baseline, 3, 6, and 12 months
Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36)
Measured: baseline, 3, 6, and 12 months
Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months
Measured: baseline, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startFeb 2005
- Primary completionJan 2006
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian von Gruenigen, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262938
- Sponsor's protocol ID
- CASE5804
- Status last verified
- Jul 2020
- First submitted
- 6 Dec 2005
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21173649von 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.
PubMed 19243603
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Change and Quality of Life in Obese Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT00262938
- Acronym / sponsor ID
- CASE5804
- Conditions
- Endometrial Cancer, Weight Changes
- Keywords
- stage I endometrial carcinoma, stage II endometrial carcinoma, weight changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Active comparator | Behavioral: behavioral dietary intervention, Other: counseling intervention, Other: educational intervention, Other: preventative dietary intervention, Procedure: quality-of-life assessmentPatients 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. |
| Without Counseling | Active comparator | Procedure: quality-of-life assessmentPatients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral dietary interventionPatients 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. | Behavioural | Lifestyle counseling |
| counseling interventionPatients 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 | Lifestyle counseling |
| educational interventionPatients 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 | Lifestyle counseling |
| preventative dietary interventionPatients 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 | Lifestyle counseling |
| quality-of-life assessmentPatients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months. | Procedure or surgery | Lifestyle counseling, Without Counseling |
Primary outcome
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
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
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
Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months
Time frame: baseline, 3, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Derived from this study: PubMed 21173649von 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.
- Derived from this study: PubMed 19243603von 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian von Gruenigen, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral dietary intervention, counseling intervention and educational intervention in people with Endometrial Cancer and Weight Changes, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: baseline, 3, 6, and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00262938, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.