Weight Loss Referral for Healthier Survivorship in Obese Stage I-II Endometrial Cancer Survivors or Atypical Hyperplasia
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/21/2018 |
| Start Date: | December 17, 2014 |
| End Date: | May 18, 2015 |
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.
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.
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.
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.
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
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