Please select the eligibility criteria that correspond to the clinical trial below.
Title: Scale Down: A Randomized, Controlled Weight Management Intervention for Women With Endometrial Cancer
Brief Summary: This proposal will pilot a weight management program for patients with endometrial cancer, the cancer most associated with obesity. If successful, this pilot could be expanded to include obese women with other gynecologic cancers (ovarian and cervical) and could be expanded and adapted for use not only upon completion of treatment, but during chemotherapy or radiation. Furthermore, other obstetricians and gynecologists could use this strategy for obese women as a practical cancer prevention strategy for obesity-associated cancers.


Options:
A: 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
B: Inclusion Criteria:

Aim 2

1. Women 18 years of age or older and with biopsy-proven endometrial cancer,
2. Body Mass Index (BMI) greater than or equal to 30 kg/m2 (based on most recent routine clinical measurement recorded in patient's medical record),
3. Must be able to read and speak English fluently, and
4. All patients must be informed of the investigational nature of the Aim 2 survey study and must give written informed consent for Aim 2 study activities in accordance with institutional and federal guidelines. (Aim 2 consent is obtained and documented as described on page 1 of the Endometrial Cancer Questionnaire).

Aim 1

1. Woman who was recruited to and completed Aim 2 of the study,
2. Has completed prior surgical or other medical management and adjuvant endometrial cancer treatment, prior to starting Aim 1,
3. Is not receiving concurrent cytotoxic chemotherapy and/or radiation therapy at time of randomization AND, after randomization, it is not anticipated that the participant will need to receive concurrent cytotoxic chemotherapy and/or radiation therapy at any time during the Aim 1 intervention,
4. No evidence of active endometrial cancer disease as determined by physician evaluation prior to randomization,
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
6. Life expectancy of at least one year,
7. Must have access to either wireless Internet, or a smart phone such as an Android or Apple iPhone, and
8. All patients must be informed of the investigational nature of this study and must sign and give written informed consent for Aim 1 study activities in accordance with institutional and federal guidelines.

Exclusion Criteria:

Aim 2

1. Must not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with Aim 2 protocol compliance or a participant's ability to give informed consent.

   4.3.2.2 Aim 1
2. Must not be participating in another weight loss program or taking weight loss medications,
3. No uncontrolled serious medical or psychiatric condition(s) that would affect the patient's ability to participate in the interventional study, e.g., uncontrolled hypertension, symptomatic cardiac disease, or severe/uncontrolled depression as indicated by a Patient Health Questionnaire (PHQ-9) score \>19, or a score of ≥1 on the suicidal ideation item (#9 on the PHQ-9)
4. No diagnoses of any other invasive malignancy other than endometrial cancer or non-melanoma skin cancer which required active treatment currently or within the last 5 years. Carcinosarcoma is not excluded as the investigators are including women with Type I and II endometrial cancer. For the purposes of the trial, carcinosarcoma falls into the Type II category.
5. No diagnoses of autoimmune disorders (including lupus, rheumatoid arthritis, Siogren's syndrome, Crohn's disease and ulcerative colitis), immune-compromised disorders (i.e., HIV/AIDS),
6. Not receiving at time of randomization, and not expected to receive at any time during the Aim 1 intervention, any medications that may affect the inflammatory markers of interest (i.e., steroids, immunosuppressants or transplant medications), and
7. Must not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with Aim 1 protocol compliance or a participant's ability to give informed consent.
8. Must not be pregnant.
C: Inclusion Criteria:

* Female women 18 years of age or older and with biopsy-proven endometrial cancer.
* BMI greater than or equal to 30 kg/m\^2.
* Must be able to read and speak English.
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent for Aim 1 study activities in accordance with institutional and federal guidelines.
* Has completed prior surgical management and adjuvant endometrial cancer treatment, if adjuvant treatment is indicated, prior to starting Aim 1.
* Is not receiving concurrent cytotoxic chemotherapy and/or radiation therapy at time of enrollment AND, if randomized, is not anticipated that the participant will need to receive concurrent cytotoxic chemotherapy and/or radiation therapy at any time during the Aim 1 intervention
* Patients with BMI greater than or equal to 30 kg/m\^2 who are undergoing hormonal treatment of endometrial cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy of at least one year
* Must have a phone capable of receiving text messages.

Exclusion Criteria:

* Females under the age of 18 years
* BMI less than 30 kg/m\^2
* Must not be participating in another formal weight loss program.
* Must not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a participant's ability to give informed consent.
* For participants who are randomized in Aim 1:

  * No uncontrolled serious medical or psychiatric condition(s) that would affect the patient's ability to participate in the interventional study, e.g., uncontrolled hypertension, symptomatic cardiac disease, or severe/uncontrolled depression as indicated by a previously completed Patient Health Questionnaire (PHQ-9) score \>9 (Kroenke)
  * No diagnoses of any other invasive malignancy other than endometrial cancer or non-melanoma skin cancer which required active treatment currently or within the last 2 years.
D: Inclusion Criteria:

* Diagnosis of breast cancer (stages I (≥1 cm), stage II, or stage IIIA, B, C excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
* BMI between 25 to 45 kg/m2
* Able to comply with all required study procedures and schedule

Exclusion Criteria:

* Serious medical condition or psychiatric illness
* Inability to be moderately physically active
* Obesity of known endocrine origin (e.g., untreated hypothyroidism, PCOS)
* Currently enrolled in a weight loss program
* Current use of weight loss medication or supplements
* Previous surgical procedures for weight reduction
* Planning weight loss surgery in the next 2 years.
* 6+ months use of meds likely to cause weight gain or prevent weight loss
* Planned surgical procedure that can impact the conduct of the study
* Currently pregnant/breastfeeding
* Planning to become pregnant within the next 2 years
* Have plans to relocate from area within 2 years
* Family relative or close friend is a trial staff member or a study participant
* Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study

Answer: C