Using SMART Design to Improve Symptom Management Strategies Among Cancer Patients

Project: Research project

Project Details

Description

Site PI will be responsible for the overall management and oversight of the project. Site PI is also responsible for supervising and monitoring the day-to-day enrollment of patients onto study, ensuring that complete enrollment data is submitted to MSU.
Site PI is responsible for ensuring that the study interveners schedule and conduct their training of friend or family member according to the reflexology and/or meditation protocols
Site PI is responsible for ensuring that the study intervener attends week 2 of the reflexology or meditation session to coach and adjust any steps during the session.
Site PI will inform the Education Coordinator of each patient’s scheduled sessions so that weekly calls can be planned.
Site PI is responsible for ensuring the enrollment of the number of patients per contract and must be willing to participate in conference calls as needed to discuss grant progress. The percent of time effort covered by the grant must be consistently available or adequate coverage must be provided.
Site PI is responsible for assisting MSU and the Recruiter to determine the protocol for notification of a patient’s provider of urgent symptoms reported at any time during the study.
Site PI must work with designated enrollment staff to remediate any violation of protocol or incompleteness of enrollment data submitted and ensure that grant policies and procedures are followed and protocol integrity is maintained.
Site PI will be responsible for implementing Quality Assurance procedures to ensure appropriate eligibility and ethical guidelines are maintained during the enrollment process.
Site PI will be responsible to supervise and monitor completion of medical record audits, ensuring that protocol is followed and that complete data is obtained and submitted to MSU.
Site PI will be responsible for submission and approval of initial IRB, annual renewals and protocol amendments to their IRB.
Site PI is responsible for ensuring that they (and all project staff) have completed all required human subjects training and HIPAA compliance modules.
Site PI is responsible for participation on relevant training and education opportunities, and contributing to the dissemination of knowledge through conference presentations and publications.
Recruiter will be responsible for enrollment of the number of dyads (patients and friend/family members) per contract and participate in monthly conference calls as needed to discuss recruitment and enrollment progress.
Recruiter will describe the study to eligible patients and follow-up with the patient and the friend/family member to answer questions.
Recruiter will seek decision on participation and obtain signed informed consent.
Copies of signed consent and authorization forms must be faxed to the MSU Project Manager. Site should keep the original forms on file in a secure location until the end of the study, when they are mailed back to MSU.
Recruiter will be responsible for submitting complete and accurate data (enrollment and intervener encounter) via the MSU secure web interface.
Submit a weekly progress report to the MSU Project Manager regarding status of enrollment.
Recruiter will be responsible for clarifying enrollment data when needed or supplying any missing enrollment data.
Recruiter will be responsible for checking on a patient’s status if the project team is unable to reach the patient for an extended period.
Recruiter will be responsible for completion of the medical record review by entering the patient chart information for the period of the patient’s partici
StatusFinished
Effective start/end date12/8/1511/30/19

Funding

  • Michigan State University (RC105782NU//5R01CA193706-04)
  • National Cancer Institute (RC105782NU//5R01CA193706-04)

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