Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomised, Controlled, Pilot Clinical Trial to Assess the Feasibility of a Healthy Eating and Physical Activity Program in Endometrial Cancer Survivors
Brief Summary: Endometrial cancer is the most common gynaecological cancer in developed countries with more than 75% of the patients surviving for at least five years. However, most endometrial cancer survivors are overweight and obese and do not meet the current nutrition and physical activity recommendations. This can lower their quality of life and increase their risk for chronic diseases. Behaviour change interventions can help them feel better about themselves and improve their quality of life. Applying them shortly after treatment seems ideal as cancer survivors feel motivated to make changes about their lifestyle at this time point.

This study is to see if the investigators can design a project to measure how well a psycho-educational healthy eating and physical activity programme tailored to the survivors' needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three years, and are all clear will be put by chance into one of two groups. One will receive the program. The other will receive usual care until the end of the trial and, then, a discussion and a self-help guide about eating well and being active following cancer treatment. This will help us to see if the programme makes a difference compared with usual care. The results will inform a larger study to test if a lifestyle program can improve the quality of life of uterine cancer survivors compared with usual care. The investigators will change the programme materials in response to the investigators' findings, making them available to services. The results will inform practice and research.


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:

* 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
C: Inclusion Criteria:

1. Women aged \>18 years (no upper age limit)
2. Women diagnosed with endometrial cancer (C54.1) within the previous 36 months
3. Women who are able to understand spoken and written English

Exclusion Criteria:

1. Women with stage IVB (metastatic) endometrial cancer (any metastasis beyond the pelvis)
2. Women on active anti-cancer, and/or palliative treatment,
3. Women having second primary cancer
4. Women who lack mental capacity to decide to take part in the study and to participate in it (upon clinical team's judgement in accordance with the Mental Capacity Act 2005 Code of Practice 2007)
5. Women with severe depression (upon consultant's judgement based on the Diagnostic and Statistical Manual of Mental Disorders-IV criteria)
6. Women unavailable for longitudinal follow-up assessments
7. Women who participated in a professionally delivered weight loss or exercise program during the previous 6 months
8. Women with a World Health Organization performance score 3-4
D: Inclusion Criteria:

1. Females with a BMI \> 30 kg/m2 wishing to retain fertility or females who are at high risk of surgical complications due to co-morbidities or obesity
2. Over 18 years of age at time of randomisation
3. Histologically confirmed complex endometrial hyperplasia with atypia or grade 1 endometrioid endometrial adenocarcinoma on a curette or endometrial biopsy
4. CT or MRI scan of pelvis, abdomen and chest (or chest X-Ray) suggesting the absence of extrauterine disease
5. Myometrial invasion on MRI of not more than 50%, for women with histologically confirmed Endometrial Cancer only (for women who are unable to fit into an MRI machine inclusion into trial is at investigators discretion)
6. No lymph vascular invasion on curetting or pipelle, if able to be assessed on sample
7. Serum CA125 ≤ 30 U/mL
8. No hypersensitivity or contraindications for Mirena
9. Ability to comply with endometrial biopsies at specified intervals
10. Negative serum or urine pregnancy test in pre-menopausal women and women \< 2 years after the onset of menopause
11. Creatinine \< 150µmol/L (1.7 mg/dL) to be randomised into Mirena + Metformin arm (can still be eligible to be randomised to Mirena only or Mirena + Weight Loss, see section 5.4 Other Eligibility Criteria Considerations)

Exclusion Criteria:

1. ECOG performance status \> 3
2. Grade 1 endometrioid adenocarcinoma of the endometrium with myometrial invasion deeper than 50% on MRI or any patients with grade 2 or grade 3 endometrioid adenocarcinoma
3. Histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high risk endometrial e.g. papillary serous, clear cell)
4. Pregnant or planning to become pregnant during trial period
5. Has had prior treatment or undergoing current treatment for EAC or EHA
6. Patients with a history of pelvic or abdominal radiotherapy
7. Unwilling to have additional endometrial biopsies or curettes and unable to attend three monthly clinical assessments
8. Unable to provide informed consent
9. Unable or unwilling to complete questionnaires
10. Evidence of extrauterine spread on medical imaging
11. Congenital or acquired uterine anomaly which distorts the uterine cavity
12. Acute pelvic inflammatory disease
13. Conditions associated with increased susceptibility to infections with microorganisms (e.g., AIDS, leukaemia, IV drug abuse) according to the patients Medical History
14. Genital actinomycosis
15. Current other cancer, except low grade malignancies that do not require any systemic treatment or treatment to the pelvis
16. Breastfeeding mothers
17. Mirena inserted greater than 12 weeks before randomisation/enrolment
18. Previous use of Mirena within the last 5 years from randomisation/enrolment
19. Contraindications to both Metformin and weight loss

Answer: C