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QUEST Study: Results of Wave 3

Colleen Pierce RN, BSN, MSc, FNPc

Morgane Swift RN, BSN, MSc, FNPc

Georgetown University

School of Nursing & Health StudiesScholarly Project, December 8, 2006

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Overview of Total QUEST Study

Participants

May 1st, 2005 through May 19th, 2006 =

3 Waves of Participants in Quest Study

129 Met Criteria for Phone Screening

52 Eligible for Enrollment

47 Consented & Randomized

17 CommitLozenges

30 QuestCigarettes

300 Responded to Advertisement

After Georgetown University IRB Approval

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Overview of Wave 3

Sample Size¾ N = 16

¾ Eight randomized toQuest cigarettes

¾ Eight randomized toCommit

Demographics: Gender:

Male = 12

Female = 4

 Age: Mean = 47 yrs

Range = 35-58 yrs

Level of 

Education: Graduate Level = 6 Undergraduate Level

= 6 with only 1 who

finished a four yeardegree

High School = 3

Ethnicity: African American = 9 Caucasian = 6 Hispanic = 1

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Selected Biological Baseline Data

0

20

40

60

80

100

120

140

160

180200

Hear t Rate SYSTOLIC DIASTOLIC WEIGHT CO

PRE

Visit 4

MEAN

83

77

MEAN

134 130

MEAN

80 75

MEAN

194 190

MEAN

21 19

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Pre and Week 4 Stress Levels

1 2 3 4

Question4

Question3

Question2

Question1

Each item addressed,Within the last week…

Upset with somethingunexpected…

Unable to control importantthings…

Felt nervous and stressed…

Dealt successfully with lifehassles…

Commit PRE

Quest PRE

Commit 4 WK 

Quest 4 WK 

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Pre and Week 4 Stress Levels

1 2 3 4

Question8

Question7

Question6

Question5

Each item addressed,Within the last week…

Effectively coping with lifechanges…

Ability to handle personalproblems…

Felt things were going yourway…

Felt you could not cope withlife’s irritations…

Commit PRE

Quest PRE

Commit 4 WK 

Quest 4 WK 

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Pre and Week 4 Stress Levels

1 2 3 4

Question12

Question11

Question10

Question9

Each item addressed,Within the last week…

Control irritations…

Felt on top of things…

Angered/could not controlthings

How often thinking aboutthings you need to

accomplish…

Commit PRE

Quest PRE

Commit 4 WK 

Quest 4 WK 

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Pre and Week 4 Stress Levels

1 2 3 4

Question14

Question13

Each item addressed,Within the last week…

Control the way you spendyour time…

Felt you could not overcomedifficulties…

Commit PRE

Quest PRE

Commit 4 WK 

Quest 4 WK 

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Snapshots on the FAB 4 Student

FNP Participants

The GOOD Our participants Our diverse research team

members Our overall learning experience

The BAD Challenges with study design Challenges of collecting bio-

markers

The UGLY Participant “life”challenges to

sustain retention

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Snapshots on the FAB 4 Student

FNP Participants

Jesus*: Quest

35 year old Hispanicmale

relapsed tx visit 6

not prepared to quit onquit date

Edgar*: Quest

45 year old Black male relapsed tx visit 1

continued to smokeown brand

*Name changed to protect participant identification

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Snapshots on the FAB 4 Student

FNP Participants

Otis*: Quest 56 year old Black male

dropped from study txvisit 4

couldn’t keep hisappointments dueto work obligations

Matthew*: Lozenge

46 year old White male quit study tx visit 3

CP x 2 episodes

PCP recommended

stopping study

*Name changed to protect participant identification

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Snapshots on the FAB 4 Student

FNP Participants

 Adam*: Quest 53 year old Black

female

family/religion majorstressors

relapsed tx visit 10

Calvin*: Quest 56 year old White male,

HEAVY smoker relapsed tx visit 3

work stress

*Name changed to protect participant identification

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Snapshots on the FAB 4 Student

FNP Participants

Danny*: Quest

49 year old Black male

no show tx visit 1

concerned about

Marijuana use

Jack*: Quest

58 year old White male

dropped tx visit 1  TRIPLED his CO levels

(21 to 72)

*Name changed to protect participant identification

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Snapshots on the FAB 4 Student

FNP Participants Kim*: Lozenge

35 year old Blackfemale dropped tx visit 1 consumed 5 lozenges

at once!

Melvin*: Quest 55 year old Black male quit tx visit 1

thought the paperworkwas too tedious kept returning for the

money!

*Name changed to protect participant identification

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Snapshots on the FAB 4 Student

FNP Participants

Brad*: Lozenge 53 year old White male relapsed tx visit 1 death in family

Wally*: Lozenge 47 year old Black male relapsed tx visit 1 too excited his

daughter was coming

to visit

*Name changed to protect participant identification

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Snapshots on the FAB 4 Student

FNP Participants

Lisa*: Quest

41 year old Whitefemale

dropped from study

visit 6 was adherent to

protocol andappointments, then

disappeared without atrace

*Name changed to protect participant identification

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And Then There was One….

 Andrew*: Quest

31 year old White male

after many obstacles(HTN, tachycardia,

wrecked motorcycle, job change) he made it!

Only participant tocomplete 14 wk study

and at the same timebecome SMOKE FREE

*Name changed to protect participant identification

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Limitations to Study

¾

Unfortunate “life”challenges forsample population

¾  Turn over rate of “part time”

laboratory staff ¾ Phlebotomy inconsistencies

¾  Topography inconsistencies

¾ Limited resources to support moreworker-friendly hours

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Implications for Advanced

Practice Nurses

¾

Value of APNs in clinical trials¾ Having “team”support for coverage for

RA/couselor with broken leg!

¾ Value of interdisciplinary research team toinclude undergraduate students

¾ Seek opportunities to partner with others

for increased sample size

¾ Sharing lessons learned

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Future Research Implications for

Advanced Practice Nurses

¾

Design similar RCT using a step-downapproach with Quest cigarettes (RE: .6 mgx 2 weeks, .3 mg x2 weeks, .05 mg x 2

weeks)¾ Design study to evaluate “what happens”

to participants who are dropped (do they

continue to try to quit using other methodsor skills they were taught during RCT)

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 Thank you from theGeorgetownUniversity Schoolof Nursing &Health Studies

FAB 4 FNPs J ourneywith a TobaccoCessation Clinical

 Trial

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Fab 4 Final Comments

Let’s help everyone

do it!

1-800-QUIT NOW