An evidence-based intervention (“Fit for Treatment”) to ...



An evidence-based intervention (“Fit for Treatment”) to prevent chemotherapy-induced neurotoxicity in breast cancer patients: An effectiveness-implementation hybrid studyIntroduction and Purpose of this StudyNeurotoxicity (i.e. physical damage to the nervous system) is a debilitating condition that can develop in individuals who undergo chemotherapy regimens. Chemotherapy regimens have also been linked with an elevated risk of cardiovascular disease. Exercise has shown to be effective in improving these neurotoxic effects and cardiovascular function after treatment, yet its potential in preventing neurotoxicity development and cardiovascular dysfunctions during treatment are still not known. Currently, a neurotoxicity-targeted exercise intervention during breast cancer chemotherapy is being run to address these toxicities at the Princess Alexandra Hospital in conjunction with The University of Queensland. You are being invited to partake in focus group discussions which will evaluate the effectiveness of this intervention. The purpose of these focus groups is to identify the resources, knowledge and skills needed to implement this exercise intervention into standard chemotherapy cancer care. Participation and WithdrawalYou have been provided with this information sheet as it has been determined by the team at the Metropolitan South Health Service, Division for Cancer Services, Princess Alexandra Hospital, that you are eligible for this study. Participation in this study is entirely voluntary. You are free to withdraw from the study at any time. Withdrawal from the study will not negatively affect your workplace relationships or performance, or affect your current or future health care. What does Participation in this Study Involve?If you consent to being included in this study, you will be asked to attend one focus group discussion that will last no longer than 90 minutes. This focus group discussion will be held at the Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102. The focus group will consist of your peers, and 1-2 researchers from this study. The date and time of the focus group will be determined at your convenience, based upon group availability.During the focus group discussion, you will be asked questions relating to your perceived feasibility of the exercise intervention, as well as the resources and personnel required to successfully implement the intervention. You will also be asked questions regarding any perceived cultural and structural barriers and facilitators to intervention implementation. Risks of Participating in this StudyThere are no foreseeable risks for partaking in this study. Although, a minor time burden will be placed upon participants. However, a focus group duration of a maximum of 90 minutes has been deemed to be sufficient to both collect the required information without a significant participant time commitment.Participant Confidentiality and Data ManagementParticipation in this study is entirely voluntary. You are free to withdraw from the study at any time. Withdrawal from the study will not negatively affect your workplace relationships or performance, or affect your ongoing health care. Two separate voice recorders will be used to record comments made during the focus groups. These recordings will be saved onto a secure external password-protected hard drive to ensure participant privacy. All identifiable data will be strictly confidential and only handled by the chief investigators for this study. When interviews are transcribed, all comments will be de-identified and stored under a unique identification (ID) number which will be assigned to you at commencement of the study. All data will be stored in accordance with the Princess Alexandra Hospital’s and University of Queensland’s relevant policies and procedures. What are the Benefits of Taking Part in this Study?Your involvement in this focus group will be essential in discussing the crucial aspects of the exercise intervention that will enable its implementation into standard cancer chemotherapy care. Furthermore, this exercise intervention has the potential to have significantly positive effects for both preventing neurotoxicity development and cardiovascular dysfunctions in women undergoing chemotherapy. ReimbursementYou will not be paid to take part in this study. Public transport options are available to this site. Access to ResultsOn completion of the focus group transcription, you will be provided with the option of receiving a copy of the transcript to confirm accuracy of your comments.Who Can I Contact?If you have any questions or concerns regarding this project, please contact Natalie Vear (Study PH: 0473 550 978). Study Investigators:Dr Tina SkinnerPhD, GCHigherEd, BAppSci(HMS – Ex Sci)(Hons)Senior Lecturer - Clinical Exercise PhysiologySchool of Human Movement and Nutrition SciencesLevel 5, Human Movement Studies Building (26B)Blair Drive, University of QueenslandSt Lucia, QLD, 4072Telephone: +61 7 3346 8810Email: t.skinner@uq.edu.auProfessor Sandie McCarthyDual Registered Nurse (Australia and New Zealand), Credentialed Cancer Nurse (Australia) PhD, MNsg, BNsg Head of SchoolSchool of NursingUniversity of AucklandTelephone: +64 0 9923 3799Email:?alexandra.mccarthy@auckland.ac.nzNatalie Vear AEP ESSAM, BExSS(CEP)(Hons)PhD CandidateSchool of Human Movement and Nutrition SciencesThe University of QueenslandStudy Telephone: 0473 550 978Email: n.vear@uq.edu.auAdjunct Associate Professor Leanne Stone RN, RM, MN, CCNAdj Associate ProfessorSchool of NursingQueensland University of TechnologyDirector of NursingDivision of Cancer ServicesMetropolitan South Hospital and Health ServiceTelephone: +61 7 3176 5124Email: leanne.stone@health..auEthical ClearanceAll research in Australia involving humans is reviewed by an independent group of people, called a Human Research Ethics Committee (HREC). The ethical aspects of this research project have been reviewed by the HRECs at all participating sites in Queensland. This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007) produced by the National Health and Medical Research Council of Australia. This statement has been developed to protect the interests of people who agree to participate in human research studies. Human Ethics Coordinator contact number: 07 336 53924An evidence-based intervention (“Fit for Treatment”) to prevent chemotherapy-induced neurotoxicity in breast cancer patients: An effectiveness-implementation hybrid studyResearch Study Title:An evidence-based intervention (“Fit for Treatment”) to prevent chemotherapy-induced neurotoxicity in breast cancer patients: An effectiveness-implementation hybrid studyStudy Principal Investigator:Dr Tina SkinnerPhD, GCHigherEd, BAppSci(HMS – Ex Sci)(Hons)Senior Lecturer – Clinical Exercise PhysiologyThe University of QueenslandCo-Investigators:Prof Sandie McCarthyDRN(Aus&NZ), CCN(Aus), PhD, MNsg, BNsg Head of School, School of NursingUniversity of AucklandNatalie VearBExSS(CEP)(Hons)PhD Candidate The University of Queensland Adj Associate Prof Leanne Stone RN, RM, MN. CCN.Adj Associate Professor, School of Nursing, QUTDirector of Nursing, Division of Cancer ServicesMetropolitan South Hospital and Health ServiceConsent to Participate in “Fit for Treatment” Focus Group StudyDeclaration by ParticipantI have read and understood the participant information sheet for this study and understand the procedures and burden involved. If required, someone has read the participant information sheet to me in language I can understand.I understand that I am able to withdraw from the study at any time without prejudice from The Princess Alexandra Hospital or The University of Queensland.I understand that I will receive no payment (monetary or otherwise) for being involved in this study. I am aware that all appropriate measures will be taken by the investigators to maintain participant confidentiality throughout this study. I have been given the opportunity to discuss the study contents with one of the investigators and any questions I may have had were answered satisfactorily. I understand that I will be given a signed copy of this document to keep. Name of Participant (please print) _____________________________________________Signature _____________________________ Date_________________________ Declaration by InvestigatorI have given a verbal explanation of the research project, its procedures and risks and I believe that the participant has understood that explanation. Name of Investigator (please print) _____________________________________________Signature _____________________________ Date__________________________ ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download