Complex Endometrial Hyperplasia With AtypiaNCT02342730
Weight Loss Referral for Healthier Survivorship in Obese Stage I-II Endometrial Cancer Survivors or Atypical Hyperplasia
A study testing Weight Loss Specialist, Quality-of-Life Assessment and Medical Chart Review in people with Complex Endometrial Hyperplasia With Atypia and Stage IA Uterine Corpus Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies whether obese stage I-II endometrial cancer survivors or patients with atypical hyperplasia (abnormal cells in the lining of the uterus) would go see a weight loss specialist if it was recommended by their cancer doctor. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Complex Endometrial Hyperplasia With Atypia, Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer
- What is being tested?
- Weight Loss Specialist, Quality-of-Life Assessment and Medical Chart Review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2014to 18 May 2015
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with a history of stage I or II endometrial cancer or a diagnosis of complex atypical hyperplasia
- BMI of at least 30 kg/msq
Who cannot join
- Advanced disease (stage III or greater)
- Recurrent or progressive endometrial cancer
- Non endometrioid histology (such as serous uterine cancer or uterine carcinosarcoma)
- History of bariatric surgery for weight loss
- Ongoing medically supervised weight loss (under the care of a physician)
- Poorly controlled psychiatric or medical conditions
- Active second primary malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Referral of Obese Endometrial Cancer Survivors to a Bariatric Specialist and a Healthier Survivorship: A Prospective Intervention Cohort Study
This pilot clinical trial studies whether obese stage I-II endometrial cancer survivors or patients with atypical hyperplasia (abnormal cells in the lining of the uterus) would go see a weight loss specialist if it was recommended by their cancer doctor. Excess body weight or obesity is one of the most common contributors to (causes of) endometrial cancer. Over two-thirds of women who have survived endometrial cancer are obese. Complications of obesity, such as heart disease are often more dangerous than the cancer itself. A weight loss of even 5-10% of excess body weight is associated with improved health. Often, meeting with a doctor or person who is an expert in weight loss (bariatric specialist) is the best way to lose weight and keep it off. Endometrial cancer survivors or patients with atypical hyperplasia who go see a weight loss specialist recommended by their doctor may be able to achieve a healthier body weight.
Read the detailed description
PRIMARY OBJECTIVES:
I.Our primary outcome for the purposes of the pilot study will be to describe recruitment in terms of accrual (number of subjects who agree to participate) and compliance (number of patients who follow up with the obesity referral). This will be described in terms of a specific number as well as a rate.
- Accrual rate is the number of women accrued divided by the number of women approached for the study.
- Compliance rate is the number of women who comply with the referral divided by the number of women accrued.
Several secondary outcomes will be described:
- Weight loss at 12 \& 24 months.
- Obesity interventions implemented (medical, surgical, behavioral, and selfguided)
- The incidence of obesity related comorbidities at baseline and 12 and 24 months (myocardial infarction, venous thromboembolism, stroke, diabetes and hypertension.)
- Cancer specific outcomes (recurrence rate, progression free survival).
- Mortality otucomes (Overall survival, cause of death)
- In patients with diabetes, we will record the number of diabetic medications required and the most recent hemoglobin A1C.
- In patients with hypertension, we will record the number of antihypertensive medications required
- We will assess the level of functioning, quality of life and symptomatology of women at baseline, 12 and 24 months using the EORTC-QLQ-C30 and EORTC-QLQ-EN24.
- Primary and secondary outcomes will be compared in relation to the timing of the referral by the gynecologic oncologist (within 1 year or greater than 1 year out from the endometrial cancer/hyperplasia diagnosis).
- Secondary outcomes of subjects included in this study will be compared to a historic cohort matches for age, stage and BMI in a 2:1 fashion.
OUTLINE:
Patients are referred to a weight loss specialist for assistance with weight loss and chart reviews are performed at baseline and every 3 months for 24 months. Patients complete the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)-Cancer (C)30 and EORTC-QLQ-Endometrial Cancer (EN)24 at baseline, 12, and 24 months. Patients are also contacted at 90 days to determine whether they have initiated any weight loss interventions.
- Conditions
- Complex Endometrial Hyperplasia With Atypia, Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer, Stage II Uterine Corpus Cancer
- Being tested
- Weight Loss Specialist, Quality-of-Life Assessment, Medical Chart Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss SpecialistBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Referred to a weight loss specialist
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete EORTC-QLQ questionnaires
Medical Chart ReviewOther
Also called Chart Review
Chart reviews are performed
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Referral | Experimental | Patients are referred to a weight loss specialist for assistance with weight loss and medical chart reviews are performed at baseline and every 3 months for 24 months. Patients complete Quality-of-Life Assessment (EORTC- QLQ-C30 and EORTC-QLQ-EN24) at baseline, 12, and 24 months. Patients are also contacted at 90 days to determine whether they have initiated any weight loss interventions. Receives: Behavioral: Weight Loss Specialist; Other: Quality-of-Life Assessment; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual with intervention, defined as number of subjects who agree to participate
Descriptive statistics will be used. Will be compared using chi square or fisher exact tests.
Measured: Up to 24 months
Compliance with intervention, defined as number of patients who follow up with the obesity referral
Descriptive statistics will be used. Will be compared using chi square or fisher exact tests.
Measured: Up to 24 months
Secondary outcomes (11)
Weight loss (in kilograms)
Descriptive statistics will be used. Will compare groups using a paired t-test.
Measured: Baseline to 12 months
Weight loss (in kilograms)
Descriptive statistics will be used. Will compare groups using a paired t-test.
Measured: Baseline to 24 months
Compliance with lifestyle changes (based on affirmative response to 3 month follow up when asked if lifestyle changes have been adopted)
Will be compared using chi square or fisher exact tests.
Measured: At 3 months
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
Descriptive statistics will be used to detail incidence of new major health events (myocardial infarction, stroke, new diabetes diagnosis, new venous thromboembolism, new hypertension diagnosis, death, date of death, cause of death). The occurrence new major health events and cancer related events will be compared using chi square or fisher exact tests.
Measured: Baseline
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
Descriptive statistics will be used to detail incidence of new major health events (myocardial infarction, stroke, new diabetes diagnosis, new venous thromboembolism, new hypertension diagnosis, death, date of death, cause of death). The occurrence new major health events and cancer related events will be compared using chi square or fisher exact tests.
Measured: At 12 months
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
Descriptive statistics will be used to detail incidence of new major health events (myocardial infarction, stroke, new diabetes diagnosis, new venous thromboembolism, new hypertension diagnosis, death, date of death, cause of death). The occurrence new major health events and cancer related events will be compared using chi square or fisher exact tests.
Measured: At 24 months
Progression free survival
Descriptive statistics will be used. Will be described with Kaplan Meier curves.
Measured: Up to 24 months
Overall survival
Descriptive statistics will be used. Will be described with Kaplan Meier curves.
Measured: Up to 24 months
Recurrence rate
Descriptive statistics will be used to detail cancer related outcomes (cancer recurrence, date and location of recurrence, cancer related death).
Measured: Up to 24 months
Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24
Will compare groups using a paired t-test.
Measured: At 12 months
Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24
Will compare groups using a paired t-test.
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study start17 Dec 2014
- Primary completion18 May 2015
- Study completion18 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Endometrial Hyperplasia With AtypiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amelia Jernigan, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342730
- Sponsor's protocol ID
- CASE13813
- Other IDs
- NCI-2014-02477, CASE13813, P30CA043703
- Status last verified
- Nov 2018
- First submitted
- 15 Jan 2015
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Referral of Obese Endometrial Cancer Survivors to a Bariatric Specialist and a Healthier Survivorship: A Prospective Intervention Cohort Study
- ClinicalTrials.gov ID
- NCT02342730
- Acronym / sponsor ID
- CASE13813
- Conditions
- Complex Endometrial Hyperplasia With Atypia, Stage IA Uterine Corpus Cancer, Stage IB Uterine Corpus Cancer, Stage II Uterine Corpus Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Dec 2014
- Primary completion
- 18 May 2015 (actual)
- Study completion
- 18 May 2015 (actual)
- First posted
- 21 Jan 2015 (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.
This pilot clinical trial studies whether obese stage I-II endometrial cancer survivors or patients with atypical hyperplasia (abnormal cells in the lining of the uterus) would go see a weight loss specialist if it was recommended by their cancer doctor. Excess body weight or obesity is one of the most common contributors to (causes of) endometrial cancer. Over two-thirds of women who have survived endometrial cancer are obese. Complications of obesity, such as heart disease are often more dangerous than the cancer itself. A weight loss of even 5-10% of excess body weight is associated with improved health. Often, meeting with a doctor or person who is an expert in weight loss (bariatric specialist) is the best way to lose weight and keep it off. Endometrial cancer survivors or patients with atypical hyperplasia who go see a weight loss specialist recommended by their doctor may be able to achieve a healthier body weight.
Detailed description
PRIMARY OBJECTIVES:
I.Our primary outcome for the purposes of the pilot study will be to describe recruitment in terms of accrual (number of subjects who agree to participate) and compliance (number of patients who follow up with the obesity referral). This will be described in terms of a specific number as well as a rate.
- Accrual rate is the number of women accrued divided by the number of women approached for the study.
- Compliance rate is the number of women who comply with the referral divided by the number of women accrued.
Several secondary outcomes will be described:
- Weight loss at 12 \& 24 months.
- Obesity interventions implemented (medical, surgical, behavioral, and selfguided)
- The incidence of obesity related comorbidities at baseline and 12 and 24 months (myocardial infarction, venous thromboembolism, stroke, diabetes and hypertension.)
- Cancer specific outcomes (recurrence rate, progression free survival).
- Mortality otucomes (Overall survival, cause of death)
- In patients with diabetes, we will record the number of diabetic medications required and the most recent hemoglobin A1C.
- In patients with hypertension, we will record the number of antihypertensive medications required
- We will assess the level of functioning, quality of life and symptomatology of women at baseline, 12 and 24 months using the EORTC-QLQ-C30 and EORTC-QLQ-EN24.
- Primary and secondary outcomes will be compared in relation to the timing of the referral by the gynecologic oncologist (within 1 year or greater than 1 year out from the endometrial cancer/hyperplasia diagnosis).
- Secondary outcomes of subjects included in this study will be compared to a historic cohort matches for age, stage and BMI in a 2:1 fashion.
OUTLINE:
Patients are referred to a weight loss specialist for assistance with weight loss and chart reviews are performed at baseline and every 3 months for 24 months. Patients complete the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)-Cancer (C)30 and EORTC-QLQ-Endometrial Cancer (EN)24 at baseline, 12, and 24 months. Patients are also contacted at 90 days to determine whether they have initiated any weight loss interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Referral | Experimental | Behavioral: Weight Loss Specialist, Other: Quality-of-Life Assessment, Other: Medical Chart ReviewPatients are referred to a weight loss specialist for assistance with weight loss and medical chart reviews are performed at baseline and every 3 months for 24 months. Patients complete Quality-of-Life Assessment (EORTC- QLQ-C30 and EORTC-QLQ-EN24) at baseline, 12, and 24 months. Patients are also contacted at 90 days to determine whether they have initiated any weight loss interventions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with a history of stage I or II endometrial cancer or a diagnosis of complex atypical hyperplasia
- BMI of at least 30 kg/msq
Key exclusion criteria (7 listed)
- Advanced disease (stage III or greater)
- Recurrent or progressive endometrial cancer
- Non endometrioid histology (such as serous uterine cancer or uterine carcinosarcoma)
- History of bariatric surgery for weight loss
- Ongoing medically supervised weight loss (under the care of a physician)
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 |
|---|---|---|
| Weight Loss SpecialistAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyReferred to a weight loss specialist | Behavioural | Weight Loss Referral |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete EORTC-QLQ questionnaires | Other | Weight Loss Referral |
| Medical Chart ReviewAlso: Chart ReviewChart reviews are performed | Other | Weight Loss Referral |
Primary outcome
Accrual with intervention, defined as number of subjects who agree to participate
Time frame: Up to 24 months
Descriptive statistics will be used. Will be compared using chi square or fisher exact tests.
Compliance with intervention, defined as number of patients who follow up with the obesity referral
Time frame: Up to 24 months
Descriptive statistics will be used. Will be compared using chi square or fisher exact tests.
11 secondary outcomes
Weight loss (in kilograms)
Time frame: Baseline to 12 months
Weight loss (in kilograms)
Time frame: Baseline to 24 months
Compliance with lifestyle changes (based on affirmative response to 3 month follow up when asked if lifestyle changes have been adopted)
Time frame: At 3 months
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
Time frame: Baseline
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
Time frame: At 12 months
Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism)
Time frame: At 24 months
Progression free survival
Time frame: Up to 24 months
Overall survival
Time frame: Up to 24 months
Recurrence rate
Time frame: Up to 24 months
Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24
Time frame: At 12 months
Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24
Time frame: At 24 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 19 Nov 2018.
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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.
Amelia Jernigan principal investigator
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 Weight Loss Specialist, Quality-of-Life Assessment and Medical Chart Review in people with Complex Endometrial Hyperplasia With Atypia and Stage IA Uterine Corpus Cancer, 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?
The sponsor lists 2 inclusion and 7 exclusion criteria. 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 19 Nov 2018. 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?
Accrual with intervention, defined as number of subjects who agree to participate (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2018.