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Overview of NCI Supported Fatigue Trials

Overview of NCI Supported Fatigue Trials. Ann O’Mara, PhD, RN, FAAN. Objectives. Review NCI supported fatigue clinical trials funded through NCI Clinical Trials Program - CCOP Investigator-initiated projects Highlight selected fatigue measures and sample sizes. Key Questions.

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Overview of NCI Supported Fatigue Trials

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  1. Overview of NCI Supported Fatigue Trials Ann O’Mara, PhD, RN, FAAN

  2. Objectives • Review NCI supported fatigue clinical trials funded through • NCI Clinical Trials Program - CCOP • Investigator-initiated projects • Highlight selected fatigue measures and sample sizes

  3. Key Questions • What are the trade-offs (lengthy vs. brief measures, complex vs. simple interventions) in conducting multi-site clinical trials? • Can multi-site trials target multiple components of fatigue?

  4. Community Clinical Oncology Program What is a CCOP? • A Group of Community Hospitals and Physicians, each with a unique structure • Funded by a Peer Reviewed Cooperative Agreement • Participate In NCI-approved Cancer Treatment, and Cancer Prevention and Control Clinical Trials • Currently, 49 CCOPs and 14 Minority-Based CCOPs

  5. Community Clinical Oncology Program What is a CCOP Research Base? • An NCI-designated Cancer Center or Cooperative Group • Funded by a Peer- Reviewed Cooperative Agreement • Develop and Conduct Cancer Prevention and Control Clinical Trials • Supports Development of Cancer Prevention Science • Currently, 13 Research Bases

  6. Univ. of Rochester NCCTG ECOG NSABP GOG RTOG Fox Chase Cancer Center CALGB COG Wake Forest University SWOG MD Anderson H. Lee Moffitt Cancer Center Research Bases (14) Minority-Based CCOPs (14) CCOP sites located throughout the US (49)

  7. Symptoms Under Study in Trials Since 1995

  8. Fatigue Trials Conducted in the CCOP Network (1995-2007)

  9. Fatigue Trials Conducted in the CCOP Network (1995-2007)

  10. Results • Of the 11 trials, 4 published results • All statistically negative • Ginseng trial showed trends

  11. Investigator-Initiated (R01, R21) Fatigue Trials (2000-2007) 93 Studies 45 Clinical Trials (Phase I-II) CBT (17) CAM (15) Yoga, Acupuncture, Polarity Tx, Massage Exercise (10) Pharmacologic (3) Methylphenidate, Pemoline, Venlafaxine,

  12. Investigator-Initiated (R01, R21) Fatigue Trials (2000-2007) – Examples of Measures Used

  13. Challenges to Conducting Clinical Trials in Networks Interventions 1.Consistency of administration (agent vs. behavioral intervention) 2. Compliance/adherence 3. Burden of administration

  14. Challenges … Data Collection 1. Consistency / Quality Control 2. Burden of collection 3. Missing Data

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