Please select the eligibility criteria that correspond to the clinical trial below.
Title: Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors
Brief Summary: Based on the investigators clinical experience in patients with chronic disease (Hui, Hui, and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui 2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a pilot study that investigates if acupuncture combined with patient education will relieve fatigue in patients who have completed primary treatment for breast cancer.


Options:
A: 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.
B: Inclusion Criteria:

1. Patient is between 18 and 65 years of age
2. Patient has a rounded Brief Fatigue Inventory score of 4 or greater
3. Patient is in a stable clinical condition

Exclusion Criteria:

1. Severe anemia (hemoglobin level less than 9 g/dL, hematocrit level less than 30, decline in hemoglobin of 2 g/dL in the previous month, or active treatment for anemia)
2. Karnofsky Performance Status below 70
3. Acupuncture treatment in the previous 6 months
4. Fatigue before cancer diagnosis
5. Patient is mentally incapacitated or unfit to provide informed consent or participate in an interview
6. Patient has the potential for serious bleeding due to inherited diseases such as hemophilia
7. Patient is taking medications that are either fatigue-inducing or have sedating properties
8. Patient is unavailable by telephone
C: 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.
D: Inclusion Criteria:

* Breast cancer patients with a BMI 27-45 kg/m2
* Diagnosis of Stage 0-IIIc disease within the past 10 years (except Stage 0, treated with mastectomy only)
* Have completed all local and systemic therapy at least 3 months prior to entry
* Have clearance from their oncologist or current medical provider to participate in a weight control study
* Must be ≤ 75 years old
* Post-menopausal
* Participants must live in a rural area
* Have access to a phone
* Able to participate in the physical activity component of the intervention, i.e., be able to walk briskly unassisted and without serious medical risk
* Weight stable within ten pounds three months prior to entry

Exclusion Criteria:

* Women with insulin-dependent diabetes
* Ongoing participation in a formal weight loss program
* Ongoing use of pharmacotherapy for weight loss
* Ongoing use of medications that seriously affect weight and metabolism (e.g., steroids, phentermine)
* Positive screen for current substance abuse, major depression, or binge eating disorder
* Any cardiac or pulmonary disease preventing participation
* Treatment for any other cancers within the past year
* Previous bariatric surgery

Answer: B