Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomised Controlled Trial of a Home-based Physical Activity Intervention in Breast Cancer Survivors
Brief Summary: The aim of this current study was to investigate the effects of a pragmatic home-based physical activity programme on primarily physical activity levels and secondarily weight maintenance, health-related quality of life (HRQoL), insulin resistance (IR) and lipid concentrations in post-adjuvant therapy breast cancer survivors.


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:

* Female 18 y and over,
* Diagnosed with invasive breast cancer (Stage I-III) within two years of enrolment and no evidence, or clinical suspicion, of metastatic disease,
* Post-surgery and had no surgery planned for the next six months at least,
* Had fully completed adjuvant therapy (radiotherapy and/or chemotherapy) not including hormonal therapy,
* No previous malignancy except in the case of ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease-free for 10 years,
* No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up,
* Willing to be randomised, and willing to maintain contact with the investigators over the six months

Exclusion Criteria:

* No evidence of invasive breast cancer (i.e. only pre-invasive disease identified),
* Previous invasive breast cancer (surgically treated DCIS or LCIS is allowed),
* Inability to participate in PA because of severe disability (e.g. severe arthritic conditions), psychiatric illness and vulnerable subjects, such as pregnant women.
* Any other patient where PA was not approved by their oncologist due to the presence of one or more contraindications to exercise in cancer patients.
C: Inclusion Criteria:

The study sample will be composed of 325 women, younger than 50 years of age, with histologically confirmed primary breast cancer (stages: T1 - T4, N0 - N1 and M0). All women will have been premenopausal at the time of diagnosis, have completed adjuvant chemotherapy (with the exception of herceptin, which can continue to receive) a minimum of 4 months and a maximum of 5 years prior to study entry. Women may currently be receiving adjuvant hormonal therapy. All women should be disease-free at time of study entry. Potentially eligible women will be screened for the presence of at least one of the following 3 menopausal symptoms during the previous 2-month period: hot flushes, sweating and/or vaginal dryness.

Exclusion Criteria:

Women will be excluded from the study if they lack basic proficiency in Dutch, if they have serious cognitive or psychiatric problems, or serious physical comorbidity that would preclude them from participating in a physical exercise program. Since physical exercise may be contraindicated as a treatment for hot flushes in obese women, 49 patients with a BMI ≥ 30 will be excluded from the study. Patients participating in concurrent studies or rehabilitation programs containing psychosocial interventions will also be excluded.
D: Inclusion Criteria:

* Aged 45-80 years
* Female
* Has been diagnosed with early-stage breast cancer
* Post-menopausal, defined as :
* Age ≥ 45 with no menses for at least 2 years
* Chemically induced menopause through ovarian suppression, as determined by the primary oncologist
* An interval of at least one year, but no more than five years, following the full completion of primary therapy for malignant disease. Primary therapy is defined as:

  * Surgery plus radiation
  * Surgery plus chemotherapy
  * Surgery plus trastuzumab
  * Surgery plus hormone therapy Note: For patients who receive hormone therapy following surgery, the definition of one-year post-completion of therapy is defined by the surgery date. Patients who are currently receiving hormone therapy are eligible for enrollment.
* Weight of \< 205 kgs
* ECOG status of 0 or 1
* Life expectancy ≥ 6 months
* Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week.
* Exercise intolerance defined by a VO2peak below that predicted for sedentary age and sex-matched individuals as defined in Appendix H.
* Willing to be randomized to one of the study arms
* Able to complete an acceptable baseline CPET, in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.
* Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:

  * Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
  * A respiratory exchange ratio ≥ 1.10;
  * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]);
  * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.

Exclusion Criteria:

* Any of the following absolute contraindications to cardiopulmonary exercise testing:

  * Acute myocardial infarction within 3-5 days of any planned study procedures;
  * Unstable angina;
  * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
  * Recurrent syncope;
  * Active endocarditis;
  * Acute myocarditis or pericarditis;
  * Symptomatic severe aortic stenosis;
  * Uncontrolled heart failure;
  * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
  * Thrombosis of lower extremities;
  * Suspected dissecting aneurysm;
  * Uncontrolled asthma;
  * Pulmonary edema;
  * Respiratory failure;
  * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis);
* Presence of any other concurrent, actively treated malignancy
* History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
* Presence of metastatic disease
* Room air desaturation at rest ≤ 85%
* Mental impairment leading to inability to cooperate
* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial

Answer: B