Table 2.
Visit 1 |
Daily |
Visit 2 |
Visit 3 |
Visit 4 |
Weekly Phone Calls |
Visit 5 |
|
---|---|---|---|---|---|---|---|
Screening (within 60 days of baseline) | Days (−7 to 70) | Baseline Week 0 | Week 3 | Week 6 | Week (−1, 1–2, 4–5 & 7–9) | Week 10 | |
Laboratory Values 1 |
X |
|
|
|
|
|
|
Medical Exam/History/Socio-demographics |
X |
|
|
|
|
|
|
Urine Pregnancy Test 1 |
X |
|
|
|
|
|
|
PRIME-MD2 |
X |
|
|
|
|
|
|
HADS 2 |
X |
|
|
|
X |
|
X |
BFI 2 |
X |
|
X |
X |
X |
X |
X |
Concomitant Medication & Supplements |
X |
|
|
|
|
|
|
Sleep Diary |
X |
|
|
|
X |
|
|
Group Randomization 3 |
|
|
X |
|
|
|
|
Actiwatch Data Collected |
|
X |
X4 |
X4 |
X4 |
|
X4 |
LTQL |
|
|
X |
|
X |
|
X |
BSAPQ 2 |
X |
|
X |
|
X |
|
X |
GSE 2 |
|
|
X |
|
X |
|
X |
BPI2 |
X |
|
X |
|
X |
|
X |
Study Logbook |
|
X |
X |
X |
X |
|
X |
PSQI 2 |
X |
|
|
|
X |
|
X |
VAS for Pain 2 |
X |
|
|
|
|
|
|
Berlin Questionnaire |
X |
|
|
|
|
|
|
Therapy Evaluation Questionnaire |
|
|
X |
|
X |
|
|
Perform Acupressure 5 |
|
|
X |
X |
X |
|
|
Assess Treatment Fidelity – Self efficacy Measure |
|
|
|
X |
X |
|
|
Adverse Events |
|
|
|
X |
X |
X |
X |
Assessment of Blinding | X |
1 Complete Blood Count; blood for correlative tests, blood for future DNA analysis, Urine pregnancy test as appropriate.
2 HADS = Hospital Anxiety Depression Scale; BFI = Brief Fatigue Inventory; and PSQI = Pittsburgh Sleep Quality Index; LTQL = Long Term Quality of Life Instrument; BSAPQ = Breast and Surrounding Areas Pain Questionnaire; GSE = General Self Efficacy Scale; BPI = Brief Pain Inventory; VAS for Pain = Visual Analog; PRIME-MD = Primary Care Evaluation of Mental Disorders.
3 Participants are randomized to one of three treatments: Standard of Care; Relaxation Acupressure; or Stimulating Acupressure.
4 Data file downloaded at these visits.
5 Does not apply to standard of care arm.