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Table 1 Eligibility Criteria vs. Source Document

From: Acupressure for persistent cancer-related fatigue in breast cancer survivors (AcuCrft): a study protocol for a randomized controlled trial

Criteria

Source

Assessor

Female breast cancer survivors

Medical Records, Michigan Tumor Registry, Medical History & Physical Exam

Study Nurse, Study Coordinator

Cancer free

Medical Records, Michigan Tumor Registry, Medical History & Physical Exam

Study Nurse, Study Coordinator

Completed treatment (i.e., surgery, chemotherapy, radiotherapy, immunotherapy, etc.) at least one year prior

Medical Records, Medical History & Physical Exam

Study Nurse, Study Coordinator

Capable of self-administering acupressure

Observation at screening visit

Study Nurse, Study Coordinator

Complaint of fatigue

Brief Fatigue Inventory score of ≥ 4

Study Nurse, Study Coordinator

Pregnant or planning to become pregnant

Pregnancy test, Medical History & Physical Exam

Study Nurse, Study Coordinator

Fatigue causing comorbidities (e.g. anemia, fibromyalgia diagnosis prior to breast cancer)

Medical Records, Medical History & Physical Exam

Study Nurse, Study Coordinator

Medication changes

Review of Concomitant Medications, Medical History & Physical Exam

Study Nurse, Study Coordinator

Acupuncture/Acupressure w/in 6 months

Communication with potential participant

Study Coordinator

Non-Breast cancer diagnosis w/in 10 years

Medical History & Physical Exam

Study Nurse

Medications for insomnia

Medical Records, Review of Concomitant Medications

Study Nurse, Study Coordinator

Untreated major depressive disorder and suicidal ideations

PRIME-MD (‘several days’ indicated on question 2i)

Study Nurse, Study Coordinator

Final, overall eligibility

Potential participant’s final review of eligibility

Principal Investigator