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Completed

NCT Number: NCT02342730

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

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.

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Key information

Conditions

Complex Endometrial Hyperplasia With Atypia Stage IA Uterine Corpus Cancer Stage IB Uterine Corpus Cancer Stage II Uterine Corpus Cancer

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Loss Specialist

Behavioral

Referred to a weight loss specialist

Other names: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Intervention

Quality-of-Life Assessment

Other

Complete EORTC-QLQ questionnaires

Other names: Quality of Life Assessment

medical chart review

Other

Chart reviews are performed

Other names: Chart Review

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Referral of Obese Endometrial Cancer Survivors to a Bariatric Specialist and a Healthier Survivorship: A Prospective Intervention Cohort Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 21, 2015
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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