Please select the eligibility criteria that correspond to the clinical trial below.
Title: ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More? Randomized Controlled Trial to Evaluate Patient Satisfaction and Cost-effectiveness of a Reduced Follow-up Schedule
Brief Summary: Background: It has often been hypothesized that the frequency of follow-up for patients with early-stage endometrial cancer could be decreased. However, studies evaluating effects of a reduced follow-up schedule among this patient group are lacking.

Objective: Assess patient satisfaction and cost-effectiveness of a less frequent follow-up schedule compared to the schedule according to the Dutch guideline.

Study design: Dutch multicentre randomized controlled trial with a 5 year follow-up. Patients (n=282) are randomized in an intervention group with 4 follow-up visits during 3 years, and a control group with 10-13 follow-up visits during 5 years, according to the Dutch guideline. Patients are asked to fill out a questionnaire at baseline, 6, 12, 36 and 60 months. Patient inclusion will take two years (if 60% of the patients participate).

Outcomes: Primary: Patient satisfaction with follow-up care and cost-effectiveness.

Secondary: health care use, adherence to schedule, health-related quality of life, fear of recurrence, anxiety and depression, information provision, recurrence, survival

Patients: Stage 1A and 1B low-risk endometrial cancer patients, for whom adjuvant radiotherapy is not indicated

Statistics: linear regression analyses to assess differences in patient satisfaction with follow-up care between intervention and control group adjusted for potential pre-defined confounders.

Expected results: Patients in the intervention arm have a similar satisfaction with follow-up care and overall outcomes, but lower health care use and costs than patients in the control arm. No effects are expected on QALY differences (losses) and satisfaction, but the reduced schedule is expected to save 144.000 per year in the Netherlands.


Options:
A: Inclusion Criteria:

* Participants will be screened for the following inclusion criteria:
* Age \>18 years
* History of stage 0, I, II, or IIIa breast cancer and no evidence of recurrent disease
* Within 6 weeks of completion of breast cancer therapy (Surgery, Radiation or Chemotherapy)
* Caucasian and/or Hispanic (English or Spanish-speaking)
* Willing to undergo a 1 hr cancer survivorship evaluation

Exclusion Criteria:

* Patients with the following active conditions or behaviors will be excluded from participation:
* Evidence of recurrent or metastatic breast cancer
* Patients who have received surgery only with no adjuvant therapy
* Uncontrolled or significant psychiatric illness/social situations that would preclude completion of questionnaire or follow-up evaluation.
B: Inclusion Criteria:

* Patients with histologically proven adenocarcinoma of the colon or rectum with Dukes Astler-Coller modification stage B2-C who had been treated with curative intent (radical excision ± adjuvant radio-chemotherapy) .
* Eligible patients had to be free of known cancer prior to study entry as attested by negative results of endoscopy, liver ultrasonography, chest roentgenography and serum CEA level performed \< 4 months before randomization

Exclusion Criteria:

* Inability to undergo testing (disability, allergy to contrast agents, etc.) and patients geographically not amenable to full follow-up.
* Patients enrolled onto any other research protocol that requires strict adherence to any specific follow-up practice.
* A history of any previous malignancy in the last 10 years (other than carcinoma in situ of the cervix or non-melanoma skin cancer).
* No informed consent to participate in the trial according to local regulatory guidelines.
C: Inclusion Criteria:

* Histologically proven malignancy of the breast
* Curative treatment
* Dominated the dutch language
* Age \> 18 year

Exclusion Criteria:

* Previously treated for a malignancy
* Psychiatric problems that adherence this study
D: Inclusion Criteria:

1. Patients with Endometrioïd type endometrial carcinoma with stage 1 (FIGO, 2009) disease, with the following combination of stage, age and grade:

   Stage 1A, any age, grade 1 or 2; Stage 1B, \< 60 years, grade 1 or 2 without LVSI;
2. Written informed consent;
3. Sufficient oral and written command of the Dutch language.

Exclusion Criteria:

1. Any other stage and type of endometrial carcinoma
2. Histological types papillary serous carcinoma or clear cell carcinoma
3. Uterine sarcoma (including carcinosarcoma)
4. Radiotherapy for current endometrial carcinoma
5. Previous malignancy (except for non-melanomatous skin cancer) \< 5 yrs
6. Confirmed Lynch syndrome
7. Previous pelvic radiotherapy

Answer: D