Overview of NCI Overview of NCI Supported Fatigue Supported Fatigue
Trials Trials
Ann O’Mara, PhD, RN, Ann O’Mara, PhD, RN, FAAN FAAN
Objectives Objectives
1.1. Review NCI supported fatigue clinical Review NCI supported fatigue clinical trials funded throughtrials funded through
a)a) NCI Clinical Trials Program - CCOPNCI Clinical Trials Program - CCOP
b)b) Investigator-initiated projectsInvestigator-initiated projects
2.2. Highlight selected fatigue measures and Highlight selected fatigue measures and sample sizes sample sizes
Key Questions Key Questions
1.1. What are the trade-offs (lengthy vs. brief What are the trade-offs (lengthy vs. brief measures, complex vs. simple measures, complex vs. simple interventions) in conducting multi-site interventions) in conducting multi-site clinical trials?clinical trials?
2.2. Can multi-site trials target multiple Can multi-site trials target multiple components of fatigue? components of fatigue?
Community Clinical Oncology ProgramCommunity Clinical Oncology Program
What is a CCOP?What is a CCOP?
A Group of Community Hospitals and A Group of Community Hospitals and Physicians, each with a unique structurePhysicians, each with a unique structure
Funded by a Peer Reviewed Cooperative Funded by a Peer Reviewed Cooperative AgreementAgreement
Participate In NCI-approved Cancer Participate In NCI-approved Cancer Treatment, and Cancer Prevention and Treatment, and Cancer Prevention and Control Clinical TrialsControl Clinical Trials
Currently, 49 CCOPs and 14 Minority-Currently, 49 CCOPs and 14 Minority-Based CCOPsBased CCOPs
Community Clinical Oncology ProgramCommunity Clinical Oncology Program
What is a CCOP Research Base?What is a CCOP Research Base? An NCI-designated Cancer Center or Cooperative An NCI-designated Cancer Center or Cooperative
GroupGroup Funded by a Peer- Reviewed Cooperative Funded by a Peer- Reviewed Cooperative
AgreementAgreement Develop and Conduct Cancer Prevention and Develop and Conduct Cancer Prevention and
Control Clinical TrialsControl Clinical Trials Supports Development of Cancer Prevention Supports Development of Cancer Prevention
ScienceScience Currently, 13 Research BasesCurrently, 13 Research Bases
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)
Symptoms Under Study in Trials Since 1995
SymptomSymptom Number of StudiesNumber of Studies
FatigueFatigue 1212
PainPain 1212
Hot FlashesHot Flashes 1111
Anorexia & Weight LossAnorexia & Weight Loss 1010
Nausea & VomitingNausea & Vomiting 99
Cognitive FunctionCognitive Function 88
MucositisMucositis 77
Quality of LifeQuality of Life 77
DiarrheaDiarrhea 66
OsteoporosisOsteoporosis 66
InfectionInfection 55
Prevention of Weight LossPrevention of Weight Loss 55
NeuropathyNeuropathy 55
Skin ToxicitiesSkin Toxicities 22
Hand & Foot SyndromeHand & Foot Syndrome 11
Others (e.g., Ascities, Depression, HRT, Sexual Others (e.g., Ascities, Depression, HRT, Sexual Functioning, Stress & Distress, etc…)Functioning, Stress & Distress, etc…)
2828
Fatigue Trials Conducted in the Fatigue Trials Conducted in the CCOP Network (1995-2007)CCOP Network (1995-2007)
ClassificationClassification Agent (# Agent (# of trials)of trials)
Sample Sample SizeSize
Fatigue Fatigue MeasureMeasure
ErythropoeticsErythropoetics Epoetin Alfa Epoetin Alfa (4)(4)
128 - 344128 - 344 QOL-LASA #1; QOL-LASA #1; BFI; FACT-An; BFI; FACT-An; Uniscale; FACT-FUniscale; FACT-F
CAMCAM American American Ginseng (1)Ginseng (1)
Levo- Levo- carnitine (1)carnitine (1)
Coenzyme Coenzyme Q10 (1)Q10 (1)
280280
352352
202202
BFI - SummaryBFI - Summary
#2 BFI – “usual”#2 BFI – “usual”
POMS-FPOMS-F
Fatigue Trials Conducted in the Fatigue Trials Conducted in the CCOP Network (1995-2007)CCOP Network (1995-2007)
ClassificationClassification Agent (# Agent (# of Trials)of Trials)
Sample Sample SizeSize
Fatigue Fatigue MeasureMeasure
PsychostimulantsPsychostimulants Methylpheni-Methylpheni-date (2)date (2)
Modafinil (1)Modafinil (1)
140; 160140; 160
837837
#2 BFI-‘usual’; #2 BFI-‘usual’; FACIT-FFACIT-F
#3 BFI – ‘worst’#3 BFI – ‘worst’
AntidepressantsAntidepressants Paroxetene Paroxetene (1)(1)
908908 #3 BFI – ‘worst’#3 BFI – ‘worst’
ResultsResults
Of the 11 trials, 4 published resultsOf the 11 trials, 4 published results All statistically negativeAll statistically negative Ginseng trial showed trendsGinseng trial showed trends
93 Studies
Investigator-Initiated (R01, R21) Investigator-Initiated (R01, R21) Fatigue Trials (2000-2007)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,
Investigator-Initiated (R01, R21) Fatigue Investigator-Initiated (R01, R21) Fatigue Trials (2000-2007) – Examples of Trials (2000-2007) – Examples of
Measures UsedMeasures Used
CBT (17) CAM
(15)
Exercise (9)
Pharmacologic (3)
Piper FSPiper FS General General Fatigue ScaleFatigue Scale
SF-36 SF-36 (Vitality)(Vitality)FACIT-FFACIT-F
Piper FSPiper FS POMS-FPOMS-F
BFI (Summary)BFI (Summary) FACT-FFACT-F
Challenges to Conducting Clinical Challenges to Conducting Clinical Trials in NetworksTrials in Networks
InterventionsInterventions
1.1. Consistency of administration (agent vs. Consistency of administration (agent vs. behavioral intervention)behavioral intervention)
2. Compliance/adherence2. Compliance/adherence
3. Burden of administration3. Burden of administration
Challenges …Challenges …
Data CollectionData Collection
1. Consistency / Quality Control1. Consistency / Quality Control
2. Burden of collection2. Burden of collection
3. Missing Data3. Missing Data
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