Table 1.
Study period | |||||||
Enrolment | Allocation | Treatment | Follow-up | ||||
Timepoint | -wk1 | wk0 | wk1 | wk3 | wk4 | wk5 | wk9 |
Enrolment | |||||||
Eligibility screen | X | ||||||
Informed consent | X | ||||||
Allocation | X | ||||||
Interventions | |||||||
EA | |||||||
Sham EA | |||||||
Usual care | |||||||
Assessments | |||||||
ISI | X | X | X | X | X | ||
PSQI | X | X | X | X | |||
Sleep diary | |||||||
Actigraphy | |||||||
FACT-F | X | X | |||||
MoCA | X | X | |||||
BDSS | X | ||||||
Salivary hormone test | X | X | |||||
Blinding/credibility test* | X | X | |||||
Adverse event | X | X | X | X | X | ||
Laboratory test† | X | X |
*Only EA and sham EA groups will undergo blinding and credibility tests.
†The laboratory test includes complete blood count and differential count, absolute neutrophil count, aspartate aminotransferase, alanine aminotransferase, total bilirubin, blood urea nitrogen, creatinine, albumin, erythrocyte sedimentation rate, thyroid-stimulating hormone, free thyroxine and human chorionic gonadotropin urine test (only for women in their childbearing years at the screening visit).
BDSS, Blood Deficiency Scoring System; EA, electroacupuncture; FACT-F, Functional Assessment of Cancer Therapy-Fatigue; ISI, Insomnia Severity Inventory; MoCA, The Montreal Cognitive Assessment; PSQI, Pittsburgh Sleep Quality Index.