DTIC ADA422948: Preferences and Utilities for Prostate Cancer Screening and Assessment of the Underlying Decision Making Process

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by  Defense Technical Information Center

Avard number: TDAMDL?-02-1-0

OTTER: Preferences and Utilities for prossate Cancer Sercening &
Trestmeat: aAssessnent of the Underlyizg Decicion Making Process

PRINCIPAL INVESTIGATOR: Jocborsh Watkins-Bruner, P5.0

CONTRACTING ORGANLUATION: Fox Chaee cancer Center
Philadelpsia, Poussylvania 19122

REPORD BATE: denuary 2904

TYPE OF REPORY: Ancwal

PREPAREE FOR: U.S. Army Medical Rescerch ard Wateriel Command
Fort Detrick, Maryland 21722 5012

DISTRIBUTION STATENENT: Approved for Public Release;
Discrifration Unlimited

the views, opinieas and/or findings contaized in chie report are
those of the euthor(s) ard shou'd not be construed az an ofCicial
Department of the Army position, policy or decision aaless so
designates oy other docanentation.

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REPORT DOCUMENTATION PAGE "onan rece

E RaPORT DATE “F RERER TVPE AND DATES COVETED
Tansey 2304 Bonen 12 Jan 2003 ~ 31 Dec 2093)
THE AR STE "5 FEE AEA

Peofermnes and Utilities Zor Peoslete Cancer screening & | DAD. 1-02-1-0055
Treatment) Aiestant of the Usdorlying Decision Making

tenor Patkice-Brunez, 9,1

7 RRR ORENATON NAMA ao ADDRESSES) “E RERFORRY DROANETTION
foe Cease Cancer Cento arom mcntaen
Thilsdstpiie, Paneyivania 29122

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-E SREORNG [NORTON TE SPONSOR MORTORRE
‘RenteY Aang? ND ABERESSIES) ‘nemo novons Netwaee

5.8, army Nrdical Reeearch and Npbesiel Command
Fore Detrick, werytuns 15702-5022

Dppesved for Gublic Release; Olatribution O-Vimized

1. ABETRREY Dinan 200 Woo

Tu preposed etudy will eveluaLe tio different populetione, & comerity sanple vithost
prostate cancer, odo Group Af at Glagnsaed are Crenled “or prostate cancsw, The slay
Je crsignea ce cvalsate tho docininurtakend meckaniem {¥.0., risk attizude veracs risk=
perceptions! end qewseese (i.o,, cognisive versue affective) taut insluence their
Proterenee for apecitie hraatwecte (e.g., suzgory wd cadiotherapy) ocd ons7cieled healt
Pinter {ive.. eewscl inpoteren aad unitary incoctinews) Io order to aseess tern! Lede
Sersua Fisk-pyrensiion two verinbler wis be coraisered, cho paint of reference of che
Tubject (Lo, pecson wilh prostate cancer vo~m persion KLEROUE prostate cunces) and the
Moy the tzcainent altorsctives ace ealmunicated of Frased (loss-izened message vert
Yadnstrsred wrsongel

Ueserstanding the docinias eaking provese Griving praterences is irpartart: hecsuse LE
Eiver ft incormacton cn how bel, Lo citimunicata or frewd aessages, Tt voulé ola give ue
» |Eeetoet ante bor pretevences ney Fe wre pulated 2d how different. wagolations say hase

Ditterant pratercnses far the nage teontwmone (e.g. eurgery) oz health staLe lec
Sroorencel. Tertker, an an yuis af how ane what grocenes “ead to groap aiffevmcee woule
dusinen fw deproved neveage Franing, Fak cercuniontions wad possibry more revevact cunl=
utility analyses.

a SOBAECT Teas ° TE ROWER OF PIG
Proobobe eanzes, decision meicing, 709, utilities, isk percepzions in
Ti SECURITY ASEPERTIT | TS, SEURTTY COASEICATION | SECURITY CLASGIFICATION |B TAWTATIOW OF REBTRET
‘oF rm raae oraasmmacr
| o melaseitica, (ser agpifisd unliniced
NOT ESAT ‘Bana Fore a8 es 7
Deborah Watki

Bruner, Pa.

‘Table of Contents

Fr Ce een
Stender Form: 298 2
Table OF COMI umn nercnrnenncnann
tr nica
Body ener
Key Research Accomplishment a
Reportable Que a suunmmannrinrinennnennnenninen
Camels tee
References _ ime SA
ARDENT mnie A
Wackins Brner, 0

DAMD17-02-1-0055 (FCCCIRB# 01-026)

L.lnvestigator: Deborah Watkins Broncr, PD

IL Tit Preferenecs and Ulililios for Prostate Canecr Sexconing &
‘Treatment: Assessment a the Underlying Decision Making,
Process

LL Grant Funding: DOD - DAMD17-02-1-0055 (27733)
IV. Project Summary:
A Introduction:

“The proposed study will evaluat two diferent populations a comenuriy sample wilhoul
prostate cancer, anda group of men ciaguosed and treated for prosiae cancer. The say
is designed to evaluate the decisionmaking mvechanisa (io. riskeattnude versus risk
perceptions) and procertes {i cognitive versa alectve) sha nfhuance their
preferences tor specific weatments (2, surgery and radiotherapy) and assoviate health
states (Lc, sexual impotence and urinary incontinence). la ceder to ansens rishatGiade
‘versus risk petception tv vasiables aust be coasidere, the point of eterenae a the
subjoet(s-poroon with prostate eancer versus person without prostate cance) and the
‘way the toateant alternatives are conuaonicstd or framed (lasseframed message Versus
sesn-framed mcosage).

[Aim 1; The proposed stay wil esses the mechanism (risk:atiade varsus1ske
perceptions) by which preferences are made for health gulcomes

‘Aim 2: The proposcd sted wil asses potcaisl masdiators of isk atinde(petoeptions,
stated preferences and calculate utiles by sxsssing ccunilive-afective ears
individusls may weigh in making risky choices trough the quantitative Risk Pereptions
Questionnaixs and the more qualitative Cognitive-Afective Melting Units
Questionnaire.

Aim 3: The proposed study will assess differences in rsk-atttude’perceptions, cogeitive-
affective profile, stated prefercnces, and calculated ntiities among the groups studied.
Watkins Bruner, De

Methods:

‘igibiity forth stay includes men between 40 ta 80 yes of wpe, For the pale
popula, men agnoed und tread for prostate cance with either sirgey ot
fadioterapy bewveen 1 and 4 year prior stuly are eligible, Palen are reerited with
{1B approval and the permission ofthe participating phsisians. The community sample
is being recruited through a wide variery of methods inching, most cee ralipand
nexepapcr ads. The commmnity sample will include men ape to MU years of age and
‘without prostne cancer.

C. Key Research Accomplishments:

41. List of untoward events that I
Droject -None

‘eaceurrui in the past year in connection with the

2. Changes of Risk Factore(s) for patients (=)
3: Namber of articipanis Interviewed or scon since the last review - 90

4. Give umber of additional parvicipanty needed in coming yenr — ‘The torl sample

size forthe study is 300, 150 patienus wiih cuneer and 15D cormmamnty participants

‘Year 1 Goewah 2S] Year? (Peaiciciy DS | Vear3 Projected 0S

Patients | Community |~Patients’ [ Community | atients | Counmuni

$3 cee a 33 2 [#

2 137 7 H

3. Description of any changes in the praineal since date of last review - None

6. Cleun copy of consent form (no stamp on consent form) -Ploase find attached twa
consent forms,

7. Hprotocol has been terminate,
completed, and

\diente reason and date, whether work was
not, why work was not completed ~ Pratowol was not terminated,

D. Outcome of Study:

‘This study did not open t averual until February 21K after Jongthy egotintions with the
DOD Human Subject Rescarch Review Board reyarding recruitment, An amendment
‘was submitted shorly there afl ty improve recruitment, which took furlher Feng
acgofiations and was finally approve on July 25, 2003. Since February of tis year we
Ihave accrued a total of 92 participants, which consisis 83 pationts and 9 meu in the
‘contral group, Most of the socrual has accurred
Watktos Bruner, D.

just singe the amendment was approved in July which permitted advanced scheduling of
Pients, und hus improved recraiimen significantly acd will continue thioughout the
remainder af the sudy reccuitment period. Every possible effort has been made ta
Jnerease the accrual of he control group. Accruat of participants through health fairs,
newspaper advertiscmeuts, focus group uccetings talking to men at shopping malls, fire
hhouses. police stations and also posting flyers and handing information regarding tho
sindy to patients" rlaives at FCCC and our network sites has boon tied fut with ite
susven: The nidio advertisements Iinully began a vir just ay of Doverber 1* 2003, Ths
response has heen overwhelming! Th thres wees we have reccived over 85 phone calls
and we have aleeady scheduled 46 men (Contral Group) to partieipute in the study over
the next several seeks. Approximately 17 uditioul mew have called in and need to be
scheduled for ant appoiotment. In between radio ads we will continue to reeruil rough
the ontioach activities montionod above and to advertice in neal newspapers. The next
sroteh of radio ads will run the mouths of February and March 2004,

Radio advertisement scems to be a very effective madia fr recruitment of our control
sarupfe, Tsing ihe sbeve-mentioncd methods and strategies, accrual fve the study seems
achievable withia Ure specified time frame,

F. References: Noue st tis tine

G. Appendioes: Noae at this time.
Watkins Brener, 0.
Page | of 2

ER CEARE

AUTHORIZATION FOR USE AND DISCLOSURE OF PROTECTED HEALTH
INFORMATION FOR RESEARCH APPROVED BY FOX CHASE CANCER CENTER
[HRB]

IRB # 01-026

Study Tle: Preferences and Ulliles for Prostate Cancer Screening &
Treaiment: Assessment of the Underlying Decision Moking Process

Principal Investigator: Deborah Watkins Bruner, PhD

The Healt Insurance Portability and Accountability Act of 1996 requires
this form, Snecifically the privacy regulations (HIPAA) permit the research
Investigators Istod above to use and disclose health information about
you for she research study identifed above which has boon approved but
the Fox Chase Cance* Cente: Institutional Review Board.

|. You authorize Fox Chase Career Center, your physicion and/or
administrative and/or clinical staff to use protected health
information collected about you and/or your familly for research
Purposes and/or disclose that protected health intonation to:

+ The Principal investigate’, Dr, Deborah Watkins Bruner, and the
Investigator’s study team:

+ The Fox Chase Cancer Center Inslitutional Review Boa'd, the
committee charged with overseeing research on human subjecls;

‘+ The Fox Chase Cancer Center Office for Data Management, which
collects and stores study data

+ The Funding Agency. Deparment of Defense.

2. Specific description of the neath information to be used and/or
disclosedt

+ Names:

= Addresses;

+ Tolophone numbers;

© Detes [i.e bisths, deaths. diagnoses):

Personal medical history:

= Family medical history;

+ Tissue/blood/cols/DNA;

PIM Auth. 4.08.03
Woking Brunery De
Page 2 of 2

= Curent and past cancer screening and ifestyle practices,
medications, therapies, diagnostics tests, surgeries, and/or biepsies;

«Quality of fe Information;

+ Curent and past symptoms related fo urination and sexual
satisfaction:

= Any information collected in the Demographic form and/or other
survey Instuments completed during Ihe course of the study.

3. This protected health information is being used and/or disclosed for
the following puposes:
To contact you during the study,

As part of this research study and for the advancement af medicine
and clinical care.

4. This authorization shal be in force anct in effect indefinitely.

8. You understand that you have the right withcraw this authafzation,
in wilting, af any time, by sending such willen notification to Dr.
Deborah Walkins Bruner, the Principal investigator of this study. You
understand that a revocction isnot effective fo the extent that your
physician has te ied! on the use or cisclosure of the protected health
infarmation,

6. You understand that if the person(s} whe receives your health
information fs net a health care provider or health plan covered by
federal privacy regulalions, your health infomation could ne longer
be protected Under this authorization.

7. Treatment by your physician willnot be atlected by whether or not
you provide cuthorization for the requested use cr disclosure except
if your treatmentis related fo research.

8. The use or disclosure requested under this authorization will not result

in direct or indirect compensation fo your phys'cien from a third
party.

Paricipant Signature Date

UIE Auth, 4.08.03
aching seuner, De
Page 1 of 3

FOX CHASE CANCER CENTER

Consent Form for Second Interview
Preferences and Liilities for Prostate Cancer Screening and Treatment:
Assessment of the Underlying Decision Making Process

You are atnong a subset of paticipants, randomly selected fromm the study we just
described, being asked to take part in a second interview. The second interview
will be very similar to the first one you are about to do with one slight difference,
This sub-study also involves questions about different treatment options but in this
interview we will give you little more information to see ft makes a difference
in your decisions. The importance of this study is to help health care professionals,
‘who review health care policies for prostate cancer, lovow what types of treatments
‘men prefer when making the decisions for treatment of prostate cancer. The nature
of the study, the risks, inconveniences and other pertinent information are
explained below. You ate urged to discuss any questions you may have about this
study with the staff members,

‘Why is the study being done?
The purpose of this study is similar to the first, to determine whieh treatment options
men prefer inost far prostate cancer, his part of the study is also being conducted to
ask men who have had prostate cancer and men who do tot have prostate cancer,
their decisions about the options that are available for the treatment of prostate
cancer. The outcome of this study will help mea, who are faced with the decision of
choosing a treatment for prostate cancer, know what other men preferred when faced
with a similar decision. Also, this study is being conducted to help health care
professionals, who examine health care policics for the treatment of prostate cancer,
understand why men prefer certain treatments over others

Pracedures
‘You agree to participate in a second interview, one to two weeks following the
first interview, where you will be asked which treatment for prostate cancer you
prefer among a series of treatments. In choosing a treatment there will
“potentially” be a different outcome for each state of health (Le. impotence or
utinary incontinence). The treatments that you choose will be referred to by name
(surgery or radiation therapy), instead of by letter (A, B, C, ete as in the first
interview) to observe whether this makes a difference in your choice of treatments,
‘You will be shown pictures to help you understand the chioices for treatments, The
interview should take approximately 45 minutes to complete.

1os02
Watkins Bruner, D.
Page 2 0f3

‘What is involved in the study?
‘You understand that when you retuen in oue to two weeks for another 45-minute
interview.

What are the risks for the study?
"There are no known risks for participating in this study, Your participation in this
study is completely voluntary. Some of the questions in the questionnaires and the
interview may seem seusitive in nature. In the event that you feel anxious,
uncomfortable or worried by some of the questions, you do not nevd te answer
them, If you feel that you need to speak to someone regarding any emotional
distress caused by answering some of these questions you may contact the Social
Work Services Department al [phone], You may withdraw from the
progtam at any time without any consequences. You may refuse this second
interview without affecting participation in the first part of this study.

Ave there any benefits to talking part in the study’?
‘As a participant in this study, the personal benefit lv you would be the possibility
of learning more about your attitudes and beliefs about prostate cancer. Your
participation in this study may hetp other men who are diagnosed with prostate
cancer make decisions about choosing a treatment, Also, you may help health care
professionals, who review policies for the treatment of prostate cancer, understand
‘why men profer certain rcatments For prostate cancer.

What abont confidentialitv?
Rone of the research information that you provide will ever be associated with
your name, No information regarding this study that can be associated with your
ame will ever be published.

How will the data be stored and protected
‘Your original interview answers will be stored in a locked cabinet indefinitely and
will not be discarded after the study has ended. This stndy has been [unded by a
‘grant from the 1.8. Army Medical Research and Material Command.
Representatives from this division are eligible to review your research records as
part of theie responsibility to protect human subjects in rescarch.

‘What are vour rights us a participant?
Participation in this s.ady is completely voluntary and you have the right to
withdeaw from the study at any time. You also understand that your medical care
will, in no way, be affected by your participation or non-participation. You

runsan,

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