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Weight Loss Referral for Healthier Survivorship in Obese Stage I-II Endometrial Cancer Survivors or Atypical Hyperplasia

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ClinicalTrials.gov Identifier: NCT02342730
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Complex Endometrial Hyperplasia With Atypia Stage IA Uterine Corpus Cancer Stage IB Uterine Corpus Cancer Stage II Uterine Corpus Cancer Behavioral: Weight Loss Specialist Other: Quality-of-Life Assessment Other: Medical Chart Review Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Referral of Obese Endometrial Cancer Survivors to a Bariatric Specialist and a Healthier Survivorship: A Prospective Intervention Cohort Study
Study Start Date : December 17, 2014
Actual Primary Completion Date : May 18, 2015
Actual Study Completion Date : May 18, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Weight Loss Referral
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.
Behavioral: Weight Loss Specialist
Referred to a weight loss specialist
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Intervention

Other: Quality-of-Life Assessment
Complete EORTC-QLQ questionnaires
Other Name: Quality of Life Assessment

Other: Medical Chart Review
Chart reviews are performed
Other Name: Chart Review




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Weight loss (in kilograms) [ Time Frame: Baseline to 12 months ]
    Descriptive statistics will be used. Will compare groups using a paired t-test.

  2. Weight loss (in kilograms) [ Time Frame: Baseline to 24 months ]
    Descriptive statistics will be used. Will compare groups using a paired t-test.

  3. 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 ]
    Will be compared using chi square or fisher exact tests.

  4. Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism) [ Time Frame: Baseline ]
    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.

  5. Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism) [ Time Frame: At 12 months ]
    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.

  6. Incidence of obesity related comorbidities and adverse events (diabetes, hypertension, myocardial infarction, stroke, venous thromboembolism) [ Time Frame: At 24 months ]
    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.

  7. Progression free survival [ Time Frame: Up to 24 months ]
    Descriptive statistics will be used. Will be described with Kaplan Meier curves.

  8. Overall survival [ Time Frame: Up to 24 months ]
    Descriptive statistics will be used. Will be described with Kaplan Meier curves.

  9. Recurrence rate [ Time Frame: Up to 24 months ]
    Descriptive statistics will be used to detail cancer related outcomes (cancer recurrence, date and location of recurrence, cancer related death).

  10. Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24 [ Time Frame: At 12 months ]
    Will compare groups using a paired t-test.

  11. Level of functioning, quality of life, and symptomatology, as measured by the EORTC-QLQ-C30 and EORTC-QLQ-EN24 [ Time Frame: At 24 months ]
    Will compare groups using a paired t-test.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342730


Locations
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United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Amelia Jernigan Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02342730     History of Changes
Other Study ID Numbers: CASE13813
NCI-2014-02477 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE13813 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Endometrial Hyperplasia
Hyperplasia
Pathologic Processes
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female