1 ACUPRESSURE FOR PERSISTENT CANCER RELATED FATIGUE 2 3 Principal Investigator: 4 Suzanna M. Zick, ND, MPH 5 24 Frank Lloyd Wright Drive 6 P.O. Box 375 Lobby M 7 Ann Arbor, MI 48106 8 Ph: 734-998-9553 9 Fax 734-998-6900 10 11 Co-Principal Investigator: 12 Richard E. Harris, PhD 13 24 Frank Lloyd Wright Drive 14 P.O. Box 375 Lobby M 15 Ann Arbor, MI 48106 16 Ph: 734-998-6996 17 Fax 734-998-6900 18 19 Co-Investigators: 20 Ananda Sen, PhD 21 J. Todd Arnedt, PhD 22 Susan Murphy, ScD, OTR 23 Gwen Wyatt, PhD, MSN, RN, FAAN 24 Brad Foerster, MD 25 26 Study Coordinators: 27 Vinita Verma / Kevin Shrestha 28 Ph: 734-998-0016 29 Fax: 734-998-6900 30 31 Project Manager 32 Benjamin Wright 33 Ph: 734-998-0031 34 Fax: 734-998-6900 35 36 University of Michigan Health Systems, Ann Arbor, MI 37 Approved by UM IRBMED: HUM00038428 38 39 Current protocol submission and version number: 40 Version 12 6/2/2014 41 42 Date of previous submission dates and version numbers: 43 Version 11 4/3/2014 44 Version 10 6/14/2013 45 Version 9 11/29/2012 46 Version 8 9/25/2012 47 Version 7 3/28/2012 48 Version 6 10/19/2011 49 Version 5 5/20/2011 50 Version 4 01/26/2011 51 Version 3 10/11/2010 52 Version 2 8/25/2010 53 Version 1 3/12/2010 Downloaded From: https://jamanetwork.com/ on 09/24/2021 Acupressure for Persistent Cancer Related Fatigue Study Protocol: Version 12 54 55 STUDY SCHEMA 56 57 ACUPRESSURE FOR PERSISTENT CANCER RELATED FATIGUE 58 59 PI: Suzanna M. Zick, ND MPH 60 PI: Richard E. Harris, PhD 61 62 63 64 5,000 BC Survivors in Michigan Tumor Registry sent letter and study brochure over 3 ½ years Interested women contact study team 500 Screening Visits 375 BC Survivors found eligible and agree to participate Randomization and then Baseline Visits 125 125 125 Relaxation Acupressure Stimulating Acupressure Standard of Care (RA) (SA) (SC) 25 Drop-outs 25 Drop-outs 25 Drop-outs Once weekly 1 wk pre-treatment 1 wk pre-treatment 1 wk pre-treatment follow-ups observation observation observation for all 3 arms 6 wks on study 6 wks on study 6 wks on study performing RA performing SA performing SC 4 wks on 4 wks on study 4 wks on study no no acupressure study no acupressure acupressure 100 Women Complete RA 100 Women Complete SA 100 Women Complete SC Arm Arm Arm PI: Zick/Harris Page 2 Date Updated: 6/16/2014 Downloaded From: https://jamanetwork.com/ on 09/24/2021 Acupressure for Persistent Cancer Related Fatigue Study Protocol: Version 12 65 TABLE OF CONTENTS 66 1.0 OBJECTIVES ............................................................................................................... 5 67 1.1 Primary Aim.......................................................................................................................... 5 68 1.2 Secondary Aims .................................................................................................................... 5 69 2.0 BACKGROUND AND SIGNIFICANCE .................................................................... 6 70 3.0 PRELIMINARY DATA ............................................................................................. 11 71 4.0 STUDY DESIGN AND METHODS.......................................................................... 14 72 4.1 Participant Selection ........................................................................................................... 14 73 4.1.1 Study Population .......................................................................................................... 14 74 4.1.2 Inclusion Criteria ......................................................................................................... 14 75 4.1.3 Exclusion Criteria ........................................................................................................ 14 76 4.1.5 Method of Participant Randomization, Stratification and Blinding ............................ 15 77 4.1.6 Recruitment .................................................................................................................. 15 78 4.1.7 Participant Reimbursement ......................................................................................... 16 79 4.2 Study Intervention ............................................................................................................... 16 80 4.2.1 Study Visits .................................................................................................................. 19 81 4.2.2 Study Measures ............................................................................................................ 22 82 4.2.3 End of Study Letter ...................................................................................................... 23 83 4.2.4 Brain Imaging – Spectroscopy ..................................................................................... 23 84 5.0 REPORTING ADVERSE EVENTS .......................................................................... 26 85 5.1 Definition ............................................................................................................................ 26 86 5.2 Definition of Acupressure-related Toxicity ........................................................................ 26 87 5.3 Frequency ............................................................................................................................ 26 88 5.4 AE Reporting and Data Elements ....................................................................................... 26 89 5.5 Severity of AEs ................................................................................................................... 27 90 5.6 Assessment of Relationship of AE to Treatment ................................................................ 27 91 5.7 Follow-up of AEs ................................................................................................................ 27 92 5.8 Serious Adverse Events (SAEs).......................................................................................... 27 93 5.9 Study Specific Adverse Event Reporting Plan ................................................................... 27 94 6.0 CONCOMITANT MEDICATION, EXERCISE, DIET AND SMOKING ............... 28 95 6.1 Limitations on Medication, Exercise, Diet and Smoking ................................................... 28 96 6.2 Documentation of Medication, Exercise, Diet and Smoking ............................................. 29 97 7.0 OFF-STUDY CRITERIA ........................................................................................... 29 98 7.1 Study Termination .............................................................................................................. 29 99 7.2 Premature Removal of a Participant ................................................................................... 29 100 7.2.1 Personal reason ............................................................................................................ 29 101 7.2.2 Lost to follow-up.......................................................................................................... 29 102 7.2.3 New illness or Medication ........................................................................................... 29 103 7.2.4 Death ............................................................................................................................ 29 104 8.0 DATA MANAGEMENT............................................................................................ 30 105 8.1 Case Report Form Set ......................................................................................................... 30 106 8.2 Data Entry, Data Management and Quality Control ........................................................... 30 107 8.3 Additional Reporting Requirements ................................................................................... 30 108 8.3.1 Protocol revisions and amendments............................................................................. 30 109 9.0 STATISTICAL METHODS ....................................................................................... 30 110 9.1 Primary and Secondary Aims ............................................................................................. 30 PI: Zick/Harris Page 3 Date Updated: 6/16/2014 Downloaded From: https://jamanetwork.com/ on 09/24/2021 Acupressure for Persistent Cancer Related Fatigue Study Protocol: Version 12 111 9.2 Sample Size Justification .................................................................................................... 33 112 10.0 ETHICAL AND REGULATORY CONSIDERATIONS ........................................ 33 113 10.1 Institutional Review Board (IRB) Approval ..................................................................... 33 114 10.2 Informed Consent .............................................................................................................. 33 115 10.3 Data and Safety Monitoring .............................................................................................. 34 116 12.3.1 Guidelines .................................................................................................................. 34 117 10.3.2 Study-specific DSMP................................................................................................. 34 118 10.4 Record Retention .............................................................................................................. 35 119 11.0 REFERENCES ......................................................................................................... 35