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Table 2 Study Visits

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

 

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. 1 Complete Blood Count; blood for correlative tests, blood for future DNA analysis, Urine pregnancy test as appropriate.
  2. 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. 3 Participants are randomized to one of three treatments: Standard of Care; Relaxation Acupressure; or Stimulating Acupressure.
  4. 4 Data file downloaded at these visits.
  5. 5 Does not apply to standard of care arm.