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

2. Objectives 1. Review NCI supported fatigue clinical trials funded through a) NCI Clinical Trials Program - CCOP b) Investigator-initiated projects 2. Highlight selected fatigue measures and sample sizes

3. Key Questions 1. What are the trade-offs (lengthy vs. brief measures, complex vs. simple interventions) in conducting multi-site clinical trials? 2. 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 A Group of Community Hospitals and Physicians, each with a unique structure Funded by a Peer Reviewed Cooperative Agreement Funded by a Peer Reviewed Cooperative Agreement Participate In NCI-approved Cancer Treatment, and Cancer Prevention and Control Clinical Trials Participate In NCI-approved Cancer Treatment, and Cancer Prevention and Control Clinical Trials Currently, 49 CCOPs and 14 Minority- Based CCOPs 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 An NCI-designated Cancer Center or Cooperative Group Funded by a Peer- Reviewed Cooperative Agreement Funded by a Peer- Reviewed Cooperative Agreement Develop and Conduct Cancer Prevention and Control Clinical Trials Develop and Conduct Cancer Prevention and Control Clinical Trials Supports Development of Cancer Prevention Science Supports Development of Cancer Prevention Science Currently, 13 Research Bases Currently, 13 Research Bases

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

7. Symptoms Under Study in Trials Since 1995 Symptom Number of Studies Fatigue12 Pain12 Hot Flashes 11 Anorexia & Weight Loss 10 Nausea & Vomiting 9 Cognitive Function 8 Mucositis7 Quality of Life 7 Diarrhea6 Osteoporosis6 Infection5 Prevention of Weight Loss 5 Neuropathy5 Skin Toxicities 2 Hand & Foot Syndrome 1 Others (e.g., Ascities, Depression, HRT, Sexual Functioning, Stress & Distress, etc…) 28

8. Fatigue Trials Conducted in the CCOP Network (1995-2007) Classification Agent (# of trials) Sample Size Fatigue Measure Erythropoetics Epoetin Alfa (4) 128 - 344 QOL-LASA #1; BFI; FACT-An; Uniscale; FACT-F CAM American Ginseng (1) Levo- carnitine (1) Coenzyme Q10 (1) 280352202 BFI - Summary #2 BFI – “usual” POMS-F

9. Fatigue Trials Conducted in the CCOP Network (1995-2007) Classification Agent (# of Trials) Sample Size Fatigue Measure Psychostimulants Methylpheni- date (2) Modafinil (1) 140; 160 837 #2 BFI-‘usual’; FACIT-F #3 BFI – ‘worst’ Antidepressants Paroxetene (1) 908 #3 BFI – ‘worst’

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

11. 93 Studies Investigator-Initiated (R01, R21) Fatigue Trials (2000-2007) 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 CBT (17)CAM (15) Exercise (9) Pharmacologic (3)  Piper FS  General Fatigue Scale  SF-36 (Vitality)  FACIT-F  Piper FS  POMS-F  BFI (Summary)  FACT-F

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