Alcohol Cessation Among Head and Neck Cancer Survivors: A Pilot RCT of a Tailored Text Message Based Intervention
Phase: NA
Conditions: Head and Neck Cancer, Alcohol Use, Unspecified
Sponsor: Northwell Health

Versi o n Date: 9 .9 .2 0 2 5  
P a ge 1  of 3 2  
St u d y Title: Alc o h ol Cessati o n A m o n g Hea d a n d Nec k Ca ncer S ur vi v ors: A Pil ot R C T of a
Tail ore d Te xt Messa ge- Base d I nter ve nti o n 
F u n de d b y U nite d States De part me nt of Defe nse: W 8 1 X W H- 2 2- 1- 0 1 8 6
PI: Mic hael Diefe n bac h, P h D 
St u d y Pr ot oc ol a n d Statistical A nal ysis Pla n
Versi o n Date: 9/ 9/ 2 0 2 5

Versi o n Date: 9 .9 .2 0 2 5  
P a ge 2  of 3 2  
R E S E A R C H P R O T O C O L  
Pr ot oc ol Title:  
Alc o h ol Cessati o n a m o n g Hea d a n d Nec k Ca ncer S ur vi v ors: A 
Pil ot R C T of a tail or e d te xt messa ge base d i nter ve nti o n  
Pri nci pal I n vesti gat or:  
Mic hael Diefe n bac h, P h D  
Pri mar y C o ntact Na me:  
S here ne La m bert  
Pri mar y C o ntact P h o ne:  
5 1 6 -2 5 3 -7 8 7 0  
Pri mar y C o ntact E -mail:  
Sla m bert 7 @ n ort h well. e d u  
Date Re vise d:  
Se pte m ber 9 , 2 0 25  
I R B N u m ber: 
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G ui deli ne s f or Pre pari n g a Researc h Pr ot oc ol 
I nstr ucti o ns: 
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Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 3  of 3 2  
 
1.   P R E VI O U S S T U D Y HI S T O R Y  
 
Has t his st u d y e ver bee n re vie we d a n d rejecte d/ disa p pr o ve d b y a n ot her I R B pri or t o 
s u b missi o n t o t his I R B? 
 
 N o   
 Yes −  if yes, please e x plai n:  
 
 
2.  B RI E F S U M M A R Y O F R E S E A R C H  
•  T he s u m m ary s h o ul d be writte n i n l a n g u a ge i ntelli gi ble t o a m o der ately e d uc ate d, 
n o n -scie ntific l ay pers o n.  
•  It s h o ul d c o nt ai n a cle ar st ate me nt of t he r ati o n ale a n d hy p ot hesis of y o ur st u dy, a 
c o ncise descri pti o n of t he met h o d ol o gy, wit h a n e m p h asis o n w h at will h a p pe n t o t he 
s u bjects, a n d a disc ussi o n of t he res ults.  
•  T his secti o n s h o ul d be ½ p a ge  
 
 
Hea d -a n d-n ec k ca nc ers ( H N C) acc o u nt f or 4 perce nt of ca ncer dia g n oses i n t he U nite d 
States a n d f or m ore t ha n 6 6, 0 0 0 a n n ual ca ncer dia g n oses. T h e p re v ale n ce r ate of H N C 
a m o n g Veter a ns is 1 5 0 % hi g h er t h a n t h e r ate i n t h e ge n er al p o p ul ati o n. T o get her wit h 
s m o ki n g, alc o h ol dri n ki n g is a maj or ris k fact or f or H N C, res p o nsi ble f or a p pr o xi matel y 
o ne -t hir d of t he cases w orl d wi de. O ver w hel mi n g e vi de nce fr o m p o p ulati o n-base d st u dies 
s h o w t hat alc o h ol dri n ki n g si g nifica ntl y i ncreases t he ris k of rec urre nce of t he pri mar y 
H N C a n d of sec o n d pri mar y mali g na ncies, as well as ne gati vel y i m pacts H N C s ur vi v ors’ 
ps yc h os ocial healt h. He nce, se veral or ga nizati o ns (i. e., A merica n Ca ncer S ociet y, 
A merica n S ociet y of Cli nica l O nc ol o g y, a n d t he W orl d Ca ncer Researc h F u n d) ha ve 
iss ue d g ui deli nes rec o m me n di n g t hat i n di vi d uals wit h H N C re d uce or a v oi d alc o h ol 
alt o get her. Des pite t hese rec o m me n dati o ns, a s u bsta ntial pr o p orti o n of H N C s ur vi v ors 
c o nti n ue t o use alc o h ol.  
 
O bjecti ve. T he o verall g oal of t he pr o p ose d researc h is t o: 1) a da pt a n e xisti n g e vi de nce -
base d te xt messa ge alc o h ol cessati o n i nter ve nti o n f or H N C s ur vi v ors i n b ot h ci vilia n a n d 
V A setti n gs (i. e., at t w o sites, N ort h well Healt h a n d t he Br o o kl y n V A Me dical Ce nter); 
an d 2) preli mi naril y e val uate, i n a t w o -ar m pil ot R C T, t he  acce pta bilit y a n d preli mi nar y 
effica c y of t he i nter ve nti o n, as well as feasi bilit y of c o n d uct a f ut ure R C T.   
 
H y p ot h eses. We h y p ot hesize t hat:  
H 1: T he tail ore d te xt -messa ge i nter ve nti o n will be 1) feasi ble t o e val uate i n  a lar ge-scale 
R C T, defi ne d as ac hie vi n g a n e nr oll me nt rate of ≥7 0 % i n t his pil ot; a n d 2) acce pta ble t o  
partici pa nts, defi ne d as a sc ore ≥4 o n a 5 -p oi nt Li kert scale ra n gi n g fr o m “ n ot at  all” t o 
“e xtre mel y” acc e pta ble.   
H 2: C o m pare d t o o ur c o ntr ol c o n diti o n of alc o h ol assess me nt a n d fee d bac k ( A F), t he 
tail ore d te xt messa ges will res ult i n a 3 0 %  i ncrease i n cessati o n a m o n g s ur vi v ors 
(ass u mi n g als o a 2 0 % i ncrease i n cessati o n i n t he A F ar m) . 
 
 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 4  of 3 2  
3.  I N T R O D U C TI O N/ B A C K G R O U N D M A T E RI A L/ P R E LI MI N A R Y S T U DI E S A N D 
SI G NI FI C A N C E  
•  D escri be a n d pr ovi de t he res ults of previ o us w ork by y o urself or ot hers , i ncl u di n g 
a ni m al st u dies, l a b or at ory st u dies, pil ot st u dies , pre-cli nic al a n d/ or cli nic al st u dies 
i nv olvi n g t he c o m p o u n d or device t o be st u die d.  
•  I ncl u de i nf or m ati o n as t o w hy y o u are c o n d ucti n g t he st u dy a n d h o w t he st u dy differs 
fr o m w h at h as bee n previ o usly res e arc he d, i ncl u di n g w h at t he k n o wle d ge g a ps are.  
•  Descri be t he i m p ort a nce of t he k n o wle d ge ex pecte d t o res ult  
 
Hea d a n d Nec k Ca ncer ( H N C ) is ca ncer of t he oral ca vit y, p har y n x, a n d lar y n x. H N C 
acc o u nts f or 4 perce nt of ca ncer dia g n oses i n t he U nite d States. H N C is partic ularl y 
ele vate d i n ser vice me m bers a n d vetera ns. A rece nt re p ort b y Ze vall os a n d c ollea g ues o n 
nati o nal tre n ds i n H N C i n t he V A s yste m de m o nstrate d t hat t he p re v ale n ce of H N C 
a m o n g Veter a ns is at 6 % a n d t h us 1 5 0 % hi g h er t h a n t h e r ate of t h e ge n er al 
p o p ul ati o n at 4 %. Bet wee n 2 0 0 6 a n d 2 0 1 2 (t he latest re p orte d ti me p oi nt) t here were 
si g nifica nt i ncreases i n i nci de nce of H N C a m o n g Vetera ns of W hite a n d Africa n A merica n 
desce nt a n d acr oss all a ge c o h orts. I n a d diti o n, t he rate of patie nts w h o ne ver s m o ke d a n d 
were dia g n ose d wit h H N C i ncrease d fr o m 8 % t o 1 5. 7 % i n 2 0 1 2. Alt h o u g h n ot as pre vale nt 
as l u n g or p r ostate ca ncer, t he rise i n i nci de nce a m o n g H N C is c o ncer ni n g a n d t here is a n 
ur ge nt nee d t o halt t he risi n g i nci de nce of H N C t hr o u g h i nter ve nti o ns tar geti n g 
be ha vi orall y -base d m o difia ble fact ors.   
 
S ur vi v ors of H N C ofte n c o pe wit h se vere l o n g -ter m c ha n ges i n t heir f u ncti o n a n d q ualit y 
of life ( Q O L) as a res ult of treat me nt. T he y ma y re q uire lifel o n g re ha bilitati o n a n d 
be ha vi oral m o dificati o n t o a dj ust t o t he c ha n ges i n oral, sali var y, a n d s wall o wi n g f u ncti o n, 
i n a d diti o n t o pai n a n d restricte d nec k a n d ar m m o bilit y. T hese f u ncti o nal c halle n ges ha ve 
a pr of o u n d i m pact o n a patie nt’s s ocial life a n d Q O L, w hic h has bee n s h o w n t o c orrelate 
wit h o verall s ur vi val i n t his p o p ulati o n.  
 
T he I nter nati o nal A ge nc y f or Researc h o n Ca ncer (I A R C) has i n dicate d t hat a ca usal 
relati o ns hi p e xists bet wee n alc o h ol use a n d t he de vel o p me nt of H N C a n d u p per 
aer o di gesti ve tract ca ncers, i ncl u di n g oral ca vit y, or o p har y n geal, h y p o p har y n geal, 
es o p ha geal, an d lar y n geal ca ncers. E vi de nce s u g gests t hat alc o h ol is res p o nsi ble f or 2 6. 4 % 
of all li p a n d oral ca vit y ca ncers, 3 0. 5 % of p har y n geal ca ncers, 2 1. 6 % of all lar y n geal 
ca ncers, a n d 1 6. 9 % of all es o p ha geal ca ncers. C o m bi ne d wit h t o bacc o use, alc o h ol 
acc o u nts f or a p pr o xi matel y 7 5 % of oral ca ncers. T he pat h wa y fr o m alc o h ol c o ns u m pti o n 
t o t he de vel o p me nt of ca ncers is n ot e ntirel y u n derst o o d; h o we ver, researc h has 
de m o nstrate d t hat alc o h ol per ma ne ntl y da ma ges t he D N A stra n ds i n t he cell t hr o u g h 
acetal de h y de, a pr o d uct of meta b olizi n g alc o h ol. Ot her p ossi ble mec ha nis ms t hr o u g h 
w hic h alc o h ol lea ds t o ca ncer are t hr o u g h n utriti o nal deficie ncies, ge netic variati o ns, a n d, 
f or fe males, c ha n ges i n estr o ge n pat h wa ys. I n o ne st u d y, c o m pare d t o a bstai ners or li g ht 
dri n kers,  t h ose c o ns u mi n g 3-4, 5 -7, 8 -1 1, or greater t ha n 1 2 dri n ks per da y ha d o d ds rati os 
of de vel o pi n g H N C of 2. 1, 5. 0, 1 2. 2, a n d 2 1. 1, res pecti vel y. T he p o ole d relati ve ris k of 
de vel o pi n g H N C was 1. 2 1 f or t h ose c o ns u mi n g less t ha n 1 dri n k per da y; w hic h is i n s tar k 
c o ntrast t o a relati ve ris k of de vel o pi n g H N C of 5. 2 4 f or t h ose c o ns u mi n g greater t ha n 4 
dri n ks per da y. A meta -a nal ysis of t he ass ociati o n bet wee n t he a m o u nt of alc o h ol dri n ki n g 
a n d ris k of H N C s h o we d t hat li g ht dri n kers ha d a relati ve ris k of 1. 1 3 f or de vel o pi n g oral 
ca vit y a n d p har y n x ca ncers, c o m pare d t o 1. 8 3 f or m o derate dri n kers, a n d 5. 1 3 f or hea v y 
dri n kers. I n a d diti o n, t he relati ve ris k f or de vel o pi n g lar y n x ca ncers is 0. 8 7 f or li g ht 
dri n kers, 1. 4 4 f or m o derate dri n kers, a n d 2. 6 5 f or hea v y dri n kers. Esti mates attri b ute 3. 5 % 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 5  of 3 2  
of ca ncer deat hs i n t he U nite d States a n d 4. 2 % of ca ncer deat hs gl o ball y directl y t o alc o h ol 
i nta ke. 
 
Rece nt data p u blis he d b y t he Ra n d or ga nizati o n pr o vi des e vi de nce of a patter n of bi n ge 
a n d hea v y dri n ki n g acr oss all ser vice bra nc hes  of t he U S militar y  Bi n ge dri n ki n g o ver t he 
past 3 0 da ys ra n ges fr o m 2 4. 1 % t o 4 4. 9 % wit h a n a vera ge acr oss all bra nc hes of 3 4. 0 %. 
Hea v y dri n ki n g ra n ges fr o m 5. 0 % t o 1 5. 3 % wit h a n a vera ge acr oss all bra nc hes of 9. 8 %. 
C o m bi ni n g t he 3 0 -da y a vera ge of bi n ge a n d hea v y dri n ki n g, s h o ws t hat al m ost 4 4 % of 
militar y pers o n nel e n ga ge i n t his u n healt h y be ha vi or.  
 
A vaila ble data s h o w t hat t h ose w h o c o nti n ue t o c o ns u me alc o h ol f oll o wi n g a pri mar y H N C 
are at i ncrease d ris k of de vel o pi n g sec o n d pri mar y mali g na ncies. I n o ne m ultice nter st u d y 
of 1 3 p o p ulati o n -base d ca ncer re gistries, c o m prisi n g nearl y 1 0 0, 0 0 0 i n di vi d uals  wit h a 
pri mar y H N C, 1 3 % of sec o n d pri mar y t u m ors were alc o h ol -relate d ca ncers. A m ultice nter 
st u d y fr o m t he I nter nati o nal Hea d a n d Nec k Ca ncer E pi de mi ol o g y C o ns orti u m, c o nsisti n g 
of o ver 4, 0 0 0 i n di vi d uals wit h H N C, s h o we d t hat c o ns u m pti o n of greater t ha n 1 alc o h olic 
dri n k per da y i ncrease d t he ris k of sec o n d pri mar y ca ncers, a m o n g t h ose wit h lar y n geal 
ca ncer ( hazar d rati o: 2. 1 1, 9 5 % CI: 1. 1 3 -3. 9 4). T his relati o ns hi p was c o nfir me d i n a 
sec o n d st u d y of ca ncers of t he u p per aer o di gesti ve tract; i n di vi d uals c o nti n ui n g t o c o ns u me 
alc o h ol p ost -dia g n osis ha d a 1. 3 ti mes greater ris k of de vel o pi n g a sec o n d pri mar y t u m or, 
c o m pare d t o t h ose w h o di d n ot use alc o h ol f oll o wi n g i nitial dia g n osis. F urt her m ore, 
c o ns u m pti o n of m ore t ha n 1 4 dri n ks per wee k was ass ociate d wit h a 5 0 % i ncrease i n ris k 
of de vel o pi n g a sec o n d pri mar y t u m or a n d pre mat ure deat h.  
 
St u dies als o str o n gl y s u g gest t hat i n di vi d uals wit h H N C, w h o c o nti n ue t o dri n k, are n ot 
o nl y at ris k of de vel o pi n g a sec o n d pri mar y t u m or b ut are als o at greater ris k of ca ncer 
rec urr e nce. I n a retr os pecti ve re vie w st u d y of 4 8 2 i n di vi d uals treate d f or a pri mar y H N C 
dia g n osis, ris k of rec urre nce was ass ociate d wit h c o ns u mi n g 8 -1 4 alc o h olic be vera ges per 
wee k. F urt her resear c h is nee de d t o el uci date t he relati o ns hi p bet wee n t he q ua ntit y of 
alc o h ol c o ns u me d a n d rec urre nc e ris ks i n s ur vi v ors of H N C. Ne gati ve ef fects of c o nti n ue d 
alc o h ol c o ns u m pti o n g o be y o n d t he de vel o p me nt of sec o n d pri mar y ca ncers a n d 
rec urr e nces, h o we ver. E vi de nce s u g gests t hat H N C s ur vi v ors, w h o c o nti n ue t o use alc o h ol, 
are at a n i ncrease d ris k of nee di n g a gastr ost o m y t u be fee di n g i n t he f u t ure a n d de vel o pi n g 
oste ora di o necr osis of t he ja w; t he y als o ha ve a p o orer disease pr o g n osis a n d are m ore 
li kel y t o s uffer fr o m s ocial effects, s uc h as u ne m pl o y me nt a n d w or k disa bilit y. C o n versel y, 
t he a bse nce of alc o h ol use b y H N C s ur vi v ors was si g nifica ntl y ass ociate d wit h better Q O L. 
A hist or y of hea v y alc o h ol c o ns u m pti o n o ver t he years, has bee n li n ke d t o f ut ure p h ysical 
a n d me ntal healt h pr o ble ms. Ha bit ual alc o h ol use, e ve n at m o derate le vels is detri me ntal t o 
ca ncer patie nts a n d s ur vi v ors a n d cessati o n eff orts wit h o ut assista nce a n d s u p p ort are 
diffic ult f or m ost s ur vi v ors.  
 
S e veral or ga nizati o ns ha ve iss ue d g ui deli nes rec o m me n di n g t hat H N C s ur vi v ors re d uce or 
a v oi d alc o h ol alt o get her. I n 2 0 1 6, t he A merica n Ca ncer S ociet y p u blis he d g ui deli nes f or 
H N C s ur vi v ors hi p, rec o m me n di n g t hat “ pri mar y care p h ysicia ns c o u nsel H N C s ur vi v or s t o 
ac hie ve a dietar y patter n t hat is hi g h i n fr uits, ve geta bles, a n d w h ole grai ns, a n d l o w i n 
sat urate d fats, s ufficie nt i n dietar y fi ber, a n d a v oi ds alc o h ol c o ns u m pti o n. I n a d diti o n, t he 
W orl d Ca ncer Researc h F u n d rec o m me n ds li miti n g alc o h ol c o ns u m pti o n  ge nerall y, a n d f or 
ca ncer pre ve nti o n, n ot t o dri n k alc o h ol at all. Lastl y, t he A merica n S ociet y of Cli nical 
O nc ol o g y rec o m me n ds re d uce d alc o h ol c o ns u m pti o n t o pre ve nt ca ncer. Des pite t hese 
str o n g rec o m me n dati o ns, e vi de nce s u g gests t hat H N C s ur vi v ors c o nti n ue t o use alc o h ol 
t hr o u g h o ut all sta ges of t he ca ncer traject or y, i ncl u di n g after i nitial ca ncer dia g n osis, 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 6  of 3 2  
d uri n g treat me nt, i nt o earl y s ur vi v ors hi p, a n d t hr o u g h l o n g -ter m s ur vi v ors hi p. A literat ure 
re vie w o n t he pre vale nce a n d effects of alc o h ol c o ns u m pti o n after oral ca ncer dia g n osis 
i n dicates t hat bet wee n 3 4 % a n d 5 7 % of s ur vi v ors of ca ncer of t he u p per aer o di gesti ve tract 
( H N C a n d es o p ha geal ca ncers) c o nti n ue t o dri n k after dia g n osis. I n a st u d y retr os pecti vel y 
assessi n g alc o h ol use bef ore H N C dia g n osis, c o m pare d t o i m me diatel y f oll o wi n g 
dia g n osis, t he pre vale nce of alc o h ol use decrease d b y 1 6. 7 %, a n d t he pr o p orti o n of 
pr o ble m dri n kers decrease d fr o m 4 6. 6 % t o 2 4. 5 %. Alt h o u g h t his is a c o nsi dera ble 
decre ase, a q uarter of t he sa m ple wit h ne wl y dia g n ose d H N C c o nti n ues t o a b use alc o h ol. 
Ot her l o n git u di nal researc h s u g gests t hat 4 4. 5 % of i n di vi d uals wit h H N C were s till 
dri n ki n g 1 2 m o nt hs after dia g n osis, wit h 2 1. 4 % of t hese i n di vi d uals cate g orize d as 
pr o ble m dri n kers ( defi ne d as t h ose w h o sc ore d 3 or m ore o n t he Mic hi ga n Alc o h olis m 
S cree ni n g Test). D uri n g earl y a n d l o n g -ter m s ur vi v ors hi p, a s u bsta ntial pr o p orti o n of H N C 
s ur vi v ors c o nti n ue t o c o ns u me alc o h ol. I n a p o p ulati o n-base d st u d y of H N C s ur vi v ors 
l o n ger t ha n 6 m o nt hs p ost-treat me nt, t here was a mere 1 3 % dri n ki n g cessati o n rate; 6 2 % of 
t he sa m ple c o nsi dere d t he msel ves c urre nt dri n kers. Of t h ose c urre nt dri n kers, a b o ut a 
q uarter of t he sa m ple (i. e., 2 6 %) re p orte d t hat t he y c o ns u me alc o h ol at least 4 ti mes per 
wee k. A st u d y of H N C s ur vi v ors 5 years p ost -treat me nt re p orte d t hat 3 8. 9 % c o nti n ue d t o 
use alc o h ol. St u dies s u g gest t hat H N C s ur vi v ors are ofte n u na ware of t he relati o ns hi p 
bet wee n alc o h ol a n d H N C, a n d d o n ot recei ve a de q uate i nf or mati o n fr o m t heir pr o vi ders 
a b o ut t he i m pact of alc o h ol o n t heir disease c o urse. I n o ne st u d y, bet wee n 1 5 -5 0 % of t h ose 
s ur ve ye d di d n ot recall ha vi n g recei ve d a n y rec o m me n dati o n re gar di n g alc o h ol 
c o ns u m pti o n. T h us, e d ucati o n a b o ut, a n d raisi n g a ware ness of, t he ris ks of alc o h ol 
c o ns u m pti o n a m o n g H N C s ur vi v ors is a necessar y first ste p t o ac hie ve alc o h ol re d ucti o n 
a n d cessati o n. T h eref ore, t h ere is a n u r ge nt n ee d f or alc o h ol cess ati o n i nter ve nti o ns 
f or t his gr o wi n g gr o u p of H N C s u r vi v ors, t o p re ve nt sec o n d m ali g n a n cies a n d c a n cer 
rec u rr e n ces, as well as t o i m p r o ve t h eir ps yc h os oci al f u n cti o ni n g. T his n ee d is 
esc al ate d f or milit ar y a n d veter a n p o p ul ati o ns, w h o are p r o n e t o ris k y d ri n ki n g  
b e h a vi or a n d f or w h o m missi o n re a di n ess d e p e n ds u p o n t h eir p h ysic al a n d m e nt al 
h e alt h. O u r p r o p os al see ks t o a d a pt a n d p reli mi n aril y e v al u ate a n e xisti n g e vi d e n ce -
b ase d alc o h ol cess ati o n i nter ve nti o n, d eli vere d vi a a n e xisti n g te xt -m ess a ge b ase d 
pl atf or m c alle d B ottle C a p, f or H N C s u r vi v ors i n b ot h ci vili a n a n d V A setti n gs.  
 
O ne st u d y, usi n g a n e d ucati o nal pa m p hlet, s h o we d t hat k n o wle d ge of alc o h ol a b use as a 
ris k fact or f or ca ncer i ncrease d fr o m 1 5 % t o 2 7 % fr o m pre- t o p ost-rea di n g. 3 5 Yet, fe w 
st u dies ha ve ai me d t o re d uce alc o h ol use s pecificall y i n t he H N C p o p ulati o n. I n a n o t her 
st u d y, researc hers de vel o pe d a n d teste d a tail ore d s m o ki n g, alc o h ol, a n d de pressi o n n urse -
a d mi nistere d i nter ve nti o n, c o nsisti n g of c o g niti ve be ha vi oral t hera p y a n d me dicati o ns, 
c o m pare d t o us ual care, f or i n di vi d uals wit h H N C. Rates of alc o h ol c o ns u m p ti o n decli ne d 
i n b ot h gr o u ps, b ut t here was n o differe nce i n t he n u m ber of pr o ble m dri n kers at t he 6-
m o nt h assess me nt p oi nt. I n a ra n d o mize d c o ntr olle d trial ( R C T) of 1 0 5 i n di vi d uals wit h 
H N C, f oc use d o n t o bacc o cessati o n, researc hers c o m pare d a pr o vi der -d eli vere d s m o ki n g 
cessati o n i nter ve nti o n wit h a us ual -care-a d vice c o ntr ol c o n diti o n; res ults s h o we d t hat 
partici pa nts e x perie nce d re d uce d s m o ki n g, b ut a n i ncre ase i n alc o h ol use 1 2 m o nt hs p ost- 
i nter ve nti o n. S ur vi v ors ma y ha ve s u bstit ute d alc o h ol f or t o bacco. We f o u n d o nl y t hree 
rele va nt st u dies ( descri be d a b o ve) tar geti n g patie nts wit h H N C, n o ne of t he m rece nt. T hese 
st u dies f oc us mai nl y o n s m o ki n g cessati o n a n d me ntal healt h o utc o mes, wit h alc o h ol 
cessati o n a sec o n dar y i nter ve nti o n tar get. O ne st u d y was desi g ne d t o i m pr o ve k n o wle d ge 
of alc o h ol as a ris k fact or f or ca ncer rec urre n ce a m o n g patie nts wit h H N C a n d ac hie ve d a 
1 2 % i ncrease i n k n o wle d ge. A n ot her st u d y c o nsiste d of a n urse -a d mi nistere d c o g niti ve 
be ha vi oral t hera p y a n d me dicati o n i nter ve nti o n, i m ple m e nte d d uri n g t he be gi n ni n g of 
treat me nt, tar geti n g s m o ki n g, alc o h ol a b use, a n d de pressi o n. At si x m o nt hs p ost dia g n osis, 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 7  of 3 2  
alt h o u g h alc o h ol, s m o ki n g a n d de pressi o n decrease d, t he n u m ber of pr o ble m dri n kers di d 
n ot differ bet wee n t he i nter ve nti o n a n d c o ntr ol c o n diti o ns. I n c o ntrast a n d acc or di n g t o o ur 
o w n data, 4 0 % of patie nts dri n k s h ortl y after treat me nt c o m pleti o n, a n d a n ot her 1 4 % 
res u me alc o h ol c o ns u m pti o n o ver t he ne xt 2 1 m o nt hs. T h us, we o bser ve d a risi n g 
pr o p orti o n of patie nts c o ns u mi n g alc o h ol, t hat after 2 years p ost dia g n osis, e xcee de d t he 
pr o p orti o n of dri n kers p ost baseli ne . T he mai n c o ncl usi o n of o ur st u d y is t hat i nter ve nti o n 
i m ple me ntati o n at t he be gi n ni n g of treat me nt is li kel y i neffect ual, as patie nts ofte n refrai n 
fr o m dri n ki n g d uri n g treat me nt, a n d i nter ve nti o n messa ges are less effecti ve se veral 
m o nt hs after deli ver y. T heref ore, we are i m ple me nti n g o ur i nter v e nti o n a n d baseli ne 
assess me nt at t he 3 -m o nt h f oll o w -u p visit after treat me nt c o m pleti o n a n d fr o m t hat p oi nt 
f oll o w-u p f or 6 -m o nt hs t o meas ure t he s uccess of o ur i nter ve nti o n. Fi nall y, t he last a n d 
t hir d st u d y i n t he literat ure f oc use d o n s m o ki n g cessati o n a m o n g patie nts wit h H N C. 
Alt h o u g h s m o ki n g decrease d, dri n ki n g i ncrease d wit hi n 1 2 m o nt hs b y 1 7 %. T his s u g gests 
t hat alc o h ol mi g ht ser ve as a s u bstit ute f or t o bacc o use, a n d t hat s pecific alc o h ol cessati o n 
messa ges are cr ucial f or cessati o n. T he pr o p ose d i nter ve nti o n i nc or p orates t he f oll o wi n g 
f o ur less o ns lear ne d fr o m t hese pri or st u dies: 1) O pti mal i nter ve nti o n i m ple me ntati o n is at 
M o nt h 3 after treat me nt c o m pleti o n, w he n, acc or di n g t o o ur data, patie nts are m ost li kel y 
t o res u me alc o h ol c o ns u m pti o n; 2) there is a nee d f or alc o h ol cessati o n s pecific messa ges; 
3) t here is a nee d f or s ustai ne d i nter ve nti o n c o nte nt deli ver y, as ca n be ac hie ve d t hr o u g h 
p h o ne te xts; a n d 4) a 9 m o nt hs f oll o w -u p assess me nt fr o m e n d of treat me nt is i deal. 
A d va nces i n tec h n ol o g y ha ve ma de electr o nicall y a d mi nistere d i nter ve nti o ns attracti ve as 
a n alter nati ve t o i nter ve nti o ns a d mi nistere d i n a m ore tra diti o nal ma n ner. Alt h o u g h n ot yet 
e val uate d i n H N C sa m ples, t he e xta nt literat ure o n electr o nicall y a d mi nistere d 
i nter ve nti o ns i n dicates t heir utilit y a n d efficac y. A re vie w of t he c urre nt literat ure s h o ws 
t hat i n di vi d uals w h o dri n k are i ntereste d i n usi n g te xt-messa ge -base d i nter ve nti o ns a n d 
s mart p h o ne-base d a p plicati o ns t o re d uce alc o h ol use. M ore s pecificall y, use of a n 
A d dicti o n C o m p re he nsi ve Healt h E n ha nce me nt S u p p ort S yste m, a s mart p h o ne a p p, b y 
t h ose wit h alc o h ol de pe n de nce was hi g h a n d s ustai ne d o ver ti me ( 9 4 % use d it i n Wee k 1; 
8 0 % c o nti n ue d i nt o Wee k 1 6). A meta -a nal ytic re vie w of 2 8 electr o nic i nter ve nti o n trials 
f or alc o h ol mis use a n d alc o h ol use dis or ders s h o we d a s mall re d ucti o n i n c o ns u m pti o n 
(a p pr o xi matel y 1 dri n k per wee k) i n a d ults a n d c olle ge st u de nts at 6 m o nt hs. M ore 
rece ntl y, a t w o-ar m R C T, c o m pari n g a n i nter ve nti o n gr o u p recei vi n g a 6 -wee k te xt 
messa ge i nter ve nti o n, a n d a c o ntr ol gr o u p t hat was referre d t o treat me nt as us ual at t he 
l ocal st u de nt healt h care ce nter, s h o we d t hat, at 3-m o nt h f oll o w -u p, t otal wee kl y alc o h ol 
c o ns u m pti o n decrease d i n b ot h gr o u ps, b ut n o si g nifica nt bet wee n -gr o u p differe nce was 
see n, p ote ntiall y d ue t o lac k of p o wer a n d t he nee d t o refi ne t he i nter ve nti o n. Yet, M ue nc h 
et al. f o u n d t hat dail y a ut o mate d te xts ca n hel p pr o ble m dri n kers re d uce dri n ki n g fre q ue nc y 
a n d q ua ntit y si g nifica ntl y m ore t ha n wee kl y self -trac ki n g messa ges. T h eref ore, we will 
d eli ver o u r alc o h ol cess ati o n i nter ve nti o n c o nte nt t hr o u g h te xt -m ess a ges.   
 
T h e i n vesti g ati ve te a m h as s u ccessf ull y recr uite d H N C p atie nts a n d s u r vi v ors i nt o 
rese arc h st u dies. Me m bers of t he researc h tea m ( Diefe n bac h & Tec kie) ha ve a hist or y of 
c olla b orati o n w or ki n g wit h H N C patie nts a n d s ur vi v ors. T he y de vel o pe d a n d e val uate d t he 
L o g Pal I O S a p plicati o n t o rec or d disease a n d treat me nt relate d si de effects a m o n g patie nts 
dia g n ose d wit h H N C, w hic h de m o nstrates t hat patie nts dia g n ose d wit h H N C are willi n g t o 
partici pate i n researc h usi n g s mart p h o ne -base d i nter ve nti o ns a n d are a d here nt  t o researc h 
pr ot oc ols. L o g Pal uses t he ec ol o gical m o me ntar y assess me nt tec h ni q ue t o rec or d patie nts’ 
s y m pt o m re p orts. L o g Pal pr o m pts patie nts t wice a wee k, at a ti me of t heir c h o osi n g, t o 
c o m plete a 2 5 -ite m list of vali date d s y m pt o ms. T he a p plicati o n was pil ot teste d a m o n g 3 6 
s ur vi v ors of H N C w h o j ust c o m plete d treat me nt. Ei g ht y perce nt of t he patie nts w h o were 
a p pr oac he d ac ce pte d. P atie nts were as ke d t o c o m plete t he assess me nts f or 2 m o nt hs. 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 8  of 3 2  
A d here nce t o t he a p p was ver y hi g h; 9 0 % of e nr olle d patie nts c o m plete d all assess me nts. 
P atie nts re p orte d t hat t he a p p was eas y t o use, t he q uesti o ns were rele va nt t o t heir 
rec o ver y, a n d di d n ot ta ke m uc h ti me t o a ns wer. Me m bers of o ur researc h tea m, u n der t he 
lea ders hi p of C o-I J o nat ha n M or ge nster n, P h. D., ha ve deca des-l o n g e x perie nc e i n t he 
de vel o p me nt a n d i m ple me ntati o n of alc o h ol cessati o n i nter ve nti o ns. T he y ha ve 
de m o nstrate d t heir effecti ve ness ( NI A A A R 3 4 A A 0 2 1 5 0 2), a n d de vel o pe d t he B ottle Ca p 
platf or m f or te xt messa ge i nter ve nti o n deli ver y. Fi n di n gs s u p p ort t he use of text mess a gi n g 
i nterve nti o ns i n re d uci n g alc o h ol use a m o n g a p o p ul ati o n of dri nkers a n d de m o nstr ate 
hi g h rete nti o n r ates a m o n g users.  
 
I n s u m, t he prese nt a p plicati o n b uil ds o n wi de-ra n gi n g pil ot data wit h lar ge sa m ple sizes, 
is base d u p o n e xte nsi ve e x perie nce i n alc o h ol cessati o n researc h c o n d ucte d b y t he 
i n vesti gati ve tea m, ca n dra w o n t he e vi de nce-base d res o urces t he tea m has de vel o pe d a n d 
e val uate d, a n d a ns wers a n ur ge nt nee d f or alc o h ol cessati o n i nter ve nti o ns f or H N C 
s ur vi v ors. T his pr oject is of hi g h si g nifica nce f or militar y a n d vetera n p o p ulati o ns, f or 
w h o m b ot h alc o h ol dri n ki n g a n d H N C is ele vate d, as H N C s ur vi v ors w h o c o nti n ue t o 
dri n k alc o h ol are at ris k f or p o or p h ysical a n d me ntal healt h o utc o mes, w hic h i m pe des 
missi o n rea di ness f or t he m a n d t heir fa mil y me m bers.    
 
 
4.  O B J E C TI V E( S)/ S P E CI FI C AI M S A N D H Y P O T H E S E S  
•  A c o ncise st ate me nt of t he g o al(s) of t he c urre nt st u dy.  
•  T he r ati o n ale f or a n d s pecific o bjectives of t he st u dy.  
•  T he g o als a n d t he hy p ot hesis t o be teste d s h o ul d be st ate d . 
 
T he pri mar y g oal of t he pr o p ose d w or k is t o assess t he acce pta bilit y of t he  pr o p ose d  
i nter ve nti o n, t o esti mate effect sizes f or t he t w o ar ms, as well as t o deter mi ne feasi bilit y of 
a f ut ure R C T.  
 
We ha ve str uct ure d t he pr o p ose d researc h i nt o t w o p hases: A n A d a pt ati o n P h ase a n d a 
Preli mi n ar y  E v al u ati o n Pil ot P h ase . T he bel o w disc usses t he o verall g oals acr oss b ot h 
sites; n ote t hat t he V A I R B will re vie w t he c o n d uct of researc h at t hat site a n d t he 
N ort h well Healt h I R B will re vie w t he c o n d uct of resear c h at o ur site.    
 
D uri n g t he A da ptati o n P hase ( Ai m 1), we will a da pt t he i nter ve nti o n; s pecificall y, we will 
a da pt alc o h ol cessati o n te xt messa ges b y tail ori n g t he m t o H N C s ur vi v ors i n b ot h ci vilia n 
a n d V A setti n gs. T his will be c o m plete d t hr o u g h ra pi d de vel o p me nt a n d e val u ati o n c ycles, 
as g ui de d b y t he O R BI T m o del, a n d wit h t he hel p of o ur P atie nt A d vis or y B oar d ( P A B ) i n 
b ot h ci vilia n  ( n = 1 5) a n d v etera n ( n = 1 5) patie nts, as well as H N C healt h care pr o vi ders 
( n = 5).  
 
D uri n g t he e val uati o n p hase ( Ai m 2), we will assess acce pta bilit y a n d preli mi nar y efficac y 
of t he i nter ve nti o n i n a 2 -ar m pil ot 6 -m o nt h l o n git u di nal  R C T . H N C s ur vi v ors ( baseli ne 
N = 1 3 8) will be e nr olle d fr o m N ort h well Healt h a n d t he Br o o kl y n V A Me dical Ce nter, at 
t he 3-m o nt h p ost treat me nt c o m pleti o n f oll o w -u p visit, w he n  alc o h ol res u m pti o n is m ost 
li kel y t o occ ur acc or di n g t o o ur pil ot data. We will ra n d o mize s ur vi v ors t o eit her t he 
c o ntr ol c o n diti o n ( A F; n = 6 9) or t he te xt messa ge i nter ve nti o n ar m, c o nsisti n g of: A F pl us 
H N C tail ore d te xts f or ci vilia ns ( n = 3 4) a n d A F pl us H N C tail ore d te xts f or Vetera ns 
( n = 3 5), f or a t otal of n = 6 9. We e x pect 1 5 % attriti o n o ver 6 m o nt hs f or a fi nal sa m ple size 
of N = 1 2 0. O ur pri mar y o utc o me is alc o h ol cessati o n at 6 m o nt hs p os t-baseli ne .  

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 9  of 3 2  
 
H y p ot h esis. D u ri n g o u r p reli mi n ar y e v al u ati o n p h ase ( Ai m 2 pil ot R C T), we will 
c o m p are o u r alc o h ol cess ati o n te xt -m ess a ge i nter ve nti o n t o a c o ntr ol c o n diti o n 
( assess m e nt a n d fee d b ac k, A F).  
H 1: T he tail ore d te xt -messa ge i nter ve nti o n will be: 1) feasi ble t o e val uate i n a f ut ure 
lar ge-scale efficac y R C T, defi ne d as ac hie vi n g a c o nse nt rate of 7 0 % d uri n g t his pil ot; a n d 
2) acce pta ble t o partici pa nts, defi ne d as a sc ore ≥4 o n a 5 -p oi nt Li kert scale r a n gi n g fr o m 
“ n ot at all” t o “e xtre mel y” acce pta ble.  
H 2: C o m pare d t o t he c o ntr ol c o n diti o n ( A F), t he tail ore d te xt messa ges will res ult i n a 
3 0 % differe nce i n alc o h ol cessati o n rate a m o n g H N C s ur vi v ors i n b ot h ci vilia n a n d V A 
setti n gs, (ass u mi n g als o a 2 0 % i ncrease i n alc o h ol cessati o n i n t he A F c o n diti o n).  
 
 
 
5.   R E S O U R C E S A V AI L A B L E T O C O N D U C T T H E H U M A N R E S E A R C H  
•  E x pl ai n t he fe asi bility of meeti n g recr uit me nt g o als of t his pr oject a n d de m o nstr ate a 
p ote nti al f or recr uiti n g t he re q uire d n u m ber of s uit a ble s u bjects wit hi n t he a gree d 
recr uit me nt peri o d 
o  H o w m a ny p ote nti al s u bjects d o y o u h ave access t o ?  
•  D escri be y o ur pr ocess t o e ns ure t h at all pers o ns assisti n g wit h t he tri al are 
a de q u ately i nf or me d a b o ut t he pr ot oc ol a n d t heir tri al rel ate d d uties a n d f u ncti o ns  
 
T he m ulti disci pli nar y researc h tea m is le d b y Dr. Mic hael A. Diefe n bac h, P h D, ( PI) a 
healt h/s ocial ps yc h ol o gist a n d be ha vi oral scie ntist wit h e x pertise i n be ha vi oral t he or y, 
i nter ve nti o n de vel o p me nt, q ualitati ve a n d q ua ntitati ve researc h met h o ds, a n d s oft ware 
desi g n. Dr. Ma ge d G hal y , M D, ( C o-I) a ra diati o n o nc ol o gist at t he Ce nter f or A d va nce d 
Me dici ne/ M o nter Ca ncer Ce nter , will s u p p ort t he pr o p ose d researc h d uri n g all p hases wit h 
her e x pertise i n H N C. T o get her, t he y c ollecte d t he alc o h ol pre vale nce data a m o n g 
s ur vi v ors of H N C a n d de vel o pe d t he L o g P al p h o ne a p plicati o n t o rec or d treat me nt -relate d 
s y m pt o ms a n d rec o ver y pr o gress a m o n g H N C s ur vi v ors. Dr. Allis o n Marzilia n o, P h. D., 
( C o-I) bri n gs c o m pli me ntar y e x pertise i n t he assess me nt of ps yc h os ocial res p o nse t o 
ill ness a n d partic ularl y h o w p h ysical ill ness i m pacts i n di vi d uals’ s ocial is olati o n, 
l o neli ness a n d relati o ns hi ps wit h ot hers, w hic h are t he pri mar y f oc us of o ur sec o n dar y 
o utc o mes. Drs. Diefe n bac h, G hal y  a n d Marzilia n o als o c o m plete d a rece nt re vie w ar ticle 
o n alc o h ol use a m o n g H N C s ur vi v ors. I n a d diti o n, Dr. J o nat ha n M or ge nster n, P h D, ( C o -I) 
ori gi nat or of t he B ottle Ca p platf or m a n d a n e x pert i n desi g ni n g alc o h ol cessati o n 
i nter ve nti o ns, a n d Dr. S vetla na Le va k, P h. D, ( C o-I) a n e x pert i n desi g ni n g te xt messa ges, 
will  c o ntri b ute t o t he researc h b y pr o vi di n g e x pertise o n t he e xisti n g e vi de nce -base d 
alc o h ol i nter ve nti o n.  Ste p ha nie Izar d, M S, a bi ostatisticia n, r o u n ds o ut t he N ort h well tea m.  
 
T his pr ot oc ol will disc uss/ descri be researc h pr oce d ures ass ociate d wit h N ort h well Healt h 
patie nts. We ha ve re q ueste d a n e xe m pti o n fr o m t he re q uire me nt t o rel y o n a si n gle I R B 
(sI R B) f or c o o perati ve researc h acc or di n g t o 4 5 C F R 4 6. 1 1 4. As s uc h, t he V A I R B will 
c o ver t he c o n d uct of researc h f or o ur c olla b orati n g researc hers.   
 
T he tea m at t he V A is c o m prise d of Drs. Da vi d S c h wartz ( C o -I) a n d J o nat ha n Wallac h 
( C o-I), C hief of Ra diati o n O nc ol o g y a n d Assista nt Pr ofess or i n Ra diati o n O nc ol o g y, 
res pecti vel y, at t he Vetera ns H os pital, Br o o kl y n, w h o will pr o vi de t he militar y a n d vetera n -
relate d e x pertise a n d assist wit h recr uit me nt of Vetera ns i nt o t he st u d y.  

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 1 0  of 3 2  
 
T he tea m will ha ve wee kl y researc h meeti n gs t o e ns ure ti mel y ac hie ve me nt of milest o nes 
a n d c o m pleti o n of t he pr o p ose d st u d y  a n d all researc h me m bers are a de q uatel y i nf or me d 
a b o ut trial -relate d d uties.  
 
N ort h well Healt h ( N W H) is t he lar gest healt h s yste m i n Ne w Y or k State, e nc o m passi n g 2 4 
h os pitals a n d 5 0 0 a m b ulat or y sites i n L o n g Isla n d, t he 5 b or o u g hs of Ne w Y or k Cit y, a n d 
Westc hester C o u nt y. H N C is mai nl y treate d at: N W H’s M o nter Ca ncer Ce nter o n L o n g 
Isla n d. W hile w e will be mai nl y recr uiti n g fr o m M o nter Ca ncer Ce nter , we will n ot 
e xcl u de N W H patie nts base d off of  t heir treat me nt l ocati o n a n d we will o pe n recr uit me nt 
t o H N C patie nts at all N W H facilities.    
 
Base d o n t he me dical rec or ds , t he N W H s yste m treat s 4 1 patie nts/ m o nt h f or H N C, yiel di n g 
a patie nt p o ol of 1 2 3 0 patie nts o ver t he 3 0 m o nt hs recr uit me nt peri o d. Base d o n t he 4 0 % 
dri n ki n g rate a n d a hi g h c o nse nt rate base d o n pri or recr uit me nt e x perie nce t his gi ves us a 
s ufficie nt p o ol of patie nts t o recr uit N = 1 3 8 H N C s ur vi v ors, n = 6 9 s ur vi v ors per ar m acr oss 
t he N W H a n d t he V A sites. I n t he e ve nt t hat t he V A site is u na ble t o meet t heir e nr oll me nt 
g oal, N ort h well will c o nti n ue e nr olli n g a d diti o nal patie nts t o e ns ure t hat t he o verall tar get 
accr u al of N = 1 3 8 patie nts is met  
 
 
 
6.   R E C R UI T M E N T M E T H O D S  
•  D escri be t he s o ur ce of p ote nti al s u bjects  
•  D escri be t he met h o ds t h at will be use d t o i de ntify p ote nti al s u bjects  
•  D escri be a ny m ateri als t h at will be use d t o recr uit s u bjects.  A c o py of a ny 
a dvertise m e nts (flyers, r a di o scri pts, etc.) s h o ul d be s u b mitte d al o n g  wit h t he 
pr ot oc ol.  
•  If m o net ary c o m pe ns ati o n is t o be offere d, t his s h o ul d be i n dic ate d i n t he pr ot oc ol 
 
Ai m 1: A d a pti o n P h ase  
T he st u d y tea m has access t o a n e xisti n g H N C P atie nt A d vis or y B oar d ( P A B), w hic h was 
ori gi nall y esta blis he d t o ai d i n t he de vel o p me nt of t he L o g Pal s oft ware pr o gra m. T his 
gr o u p of male a n d fe male s ur vi v ors will be t he pri mar y p o ol of p ote ntial partici pa nts t o 
ac hie ve Ai m 1. If nee de d, the st u d y tea m pla ns t o f urt her recr uit ci vilia n H N C s ur vi v ors 
fr o m N ort h well Healt h as nee de d t o reac h c o m plete data  g oals f or Ai m 1 ( n = 1 5 N ort h well 
patie nts) , via p h o ne calls  a n d maile d (e mail a n d/ or p h ysical) o utreac h recr uit me nt met h o ds , 
after first sca n ni n g t he E M R t o i de ntif y eli gi ble partici pa nts . A d diti o nall y, 3  treati n g H N C 
pr o vi ders w h o treat p ote ntial partici pa nts t hat we ma y a p pr oac h f or partici pati o n i n t his 
resear c h will be i de ntifie d t o als o partici pate i n Ai m # 1.  
 
Ai m 2: Preli mi n ar y E v al u ati o n P h ase  
R esearc h  c o or di nat ors ( R C) at N W H will sca n t he E M R rec or ds  facilitate d b y patie nt lists 
ge nerate d b y o ur data a nal yst  t o i de ntif y eli gi ble s ur vi v ors d ue f or t heir first sta n dar d of 
care cli nical visit after treat me nt . T o s u p ple me nt t hese eff orts, t he st u d y tea m will use t he 
O nc ora a n d A RI A data bases w hic h are use d b y N ort h well’s ra diati o n o nc ol o g y de part me nt 
t o create patie nt c o h orts f or researc h p ur p oses. We will use t he filteri n g ca pa bilities wit hi n 
t hese data bases t o create lists of eli gi ble H N C s ur vi v ors wit hi n t he N ort h well s yste m.  

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 1 1  of 3 2  
E li gi bilit y a n d per missi o n t o a p pr oac h will be c o nfir me d b y t he c olla b orati n g pr o vi ders ; if 
t he pr o vi der d oes n ot res p o n d t o t he re q uest wit hi n o ne wee k, t he y will be asse nte d b y 
defa ult.  St u d y  staff will c o ntact s ur vi v ors b y p h o ne a n d via m y N ort h well t o  assess i nterest 
i n t he st u d y. O nce eli gi bilit y has bee n esta blis he d, i ntereste d patie nts  will be as ke d t o meet 
st u d y R Cs after t he re g ularl y sc he d ule d a p p oi nt me nt, a n d t o e x pect t hat t he visit will be 
e xte n de d b y 4 5 -6 0 mi n utes. At t he e n d of t he cli nic visi t, t he H N C s ur vi v or will meet wit h 
t he R C t o gi ve i nf or me d c o nse nt, rec or d baseli ne data, a n d assess dri n ki n g patter ns wit h 
t he A U DI T q uesti o n naire a n d t he Ti me-Li ne F oll o w Bac k ( T L F B) alc o h ol use assess me nt 
pr oce d ure. P atie nts will als o ha ve t he o pti o n t o elect t o c o nse nt a n d c o m plete 
q uesti o n naires virt uall y.  Ra n d o mizati o n will occ ur after t he patie nt is c o nse nte d.  T he R C 
will access t he ra n d o mizati o n we bsite a n d pr o vi de alc o h ol use fee d bac k, pl us, if 
ra n d o mize d t o t he i nter ve nti o n ar m, re gister t he H N C sur vi v or wit h t he B ottle Ca p 
platf or m.  
 
S ur vi v ors w h o ha ve c o nse nte d t o partici pate will be bl oc k ra n d o mize d t o eit her A F or t he 
i nter ve nti o n te xt messa gi n g ar m. T his pr oce d ure will e ns ure t hat e ve n n u m bers per 
c o n diti o n acr oss sites are mai ntai ne d o verall.  
 
 
7.   E LI GI BI LI T Y C RI T E RI A  
•  Descri be t he c h ar acteristics of t he s u bject p o p ul ati o n, i ncl u di n g t heir a ntici p ate d 
n u m ber, a ge, r a n ges, sex, et h nic b ack gr o u n d, a n d he alt h st at us. I de ntify t he criteri a 
f or i ncl usi o n or excl usi o n of a ny s u b p o p ul ati o n.  
•  E x pl ai n t he r ati o n ale f or t he i nv olve me nt of s peci al cl asses of s u bjects, s uc h as 
fet uses, pre g n a nt w o me n, c hil dre n, pris o ners or ot her i nstit uti o n alize d i n divi d u als, or 
ot hers w h o are likely t o be v ul ner a ble.   Y o u c a n n ot i ncl u de t hese p o p ul ati o ns i n y o ur 
rese arc h, u nless y o u i n dic ate s uc h i n t he pr ot oc ol 
•  Si mil arly, det ail excl usi o n ary criteri a: a ge li mits, s peci al p o p ul ati o ns ( mi n ors, 
pre g n a nt w o me n, decisi o n ally i m p aire d), use of c o nc o mit a nt me dic ati o ns, s u bjects 
wit h ot her dise ases, severity of ill ness, etc.  
 
He alt h c are W or k ers ( Ai m  1)  
I ncl usi o n Criteria: 
1)  E m pl o ye d as a p h ysicia n or n urs e 
2)  C urre ntl y treati n g hea d a n d nec k ca ncer patie nts (s ur gicall y or wit h ra diati o n)  
 
E xcl usi o n Criteria:  
N/ A  
 
P atie nt A d vis or y B o ar d ( Ai m 1) a n d P arti ci p a nts ( Ai m 2)  
Incl usi o n C riteria: 
1)  A d ult male or fe male patie nts 1 8 years or ol der  
2)  D ia g n ose d wit h pri mar y ca ncer of: p har y n x ( nas o p har y n x, or o p har y n x, 
h y p o p har y n x), lar y n x (all s u bsites), oral ca vit y (all s u bsites ) 
3)  H a vi n g c o m plete d s ur gical, ra diati o n, a n d/ or c he m ot hera p y treat me nt;  
4)  P ost -treat me nt c o m pleti o n stat us of at least 3 m o nt hs;  
5)  A ble t o c o m m u nicate a n d rea d i n E n glis h;  
6)  P ossess a tele p h o ne wit h te xt messa gi n g ca pa bilit y; a n d  
7)  C o nfir mati o n of alc o h ol c o ns u m pti o n.  

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 1 2  of 3 2  
 
E xcl usi o n Criteria:  
1)  N o n -E n glis h s pea ker  
2)  N o n -dri n ker  
3)  Pre vi o usl y e nr olle d i n Ai m 1  (f or Ai m 2 o nl y) 
4)  Cli nicall y si g nifica nt de pressi o n, as i n dicate d b y a n assess me nt of ≥ 1 6 o n t he 
C E S -D 1 1 -ite m I o wa s h ort f or m scale ( Ai m 2 o nl y) 
 
 
8.   N U M B E R O F S U B J E C T S  
•  In dic ate t he t ot al n u m ber of s u bjects t o be accr ue d l oc ally.  I f a p plic a ble, disti n g uis h 
bet wee n t he n u m ber of s u bjects w h o are ex pecte d t o be pre -scree ne d, e nr olle d 
(c o nse nt o bt ai ne d), r a n d o mize d a n d c o m plete t he rese arc h pr o ce d ures. 
•  If y o ur st u dy i ncl u des differe nt c o h orts, i ncl u de t he t ot al n u m ber of s u bjects i n e ac h 
c o h ort.  
•  If t his is m ultisite st u dy, i ncl u de t ot al n u m ber of s u bjects acr oss all sites.   
 
Ai m 1  
F or t his p hase of t he researc h, we will e nr oll u ntil 1 5  P A B me m bers a n d u p t o 5 healt hcare 
w or kers c o m plete Ai m # 1 researc h pr oce d ures at N ort h well.     
 
Ai m 2  
F or t his p hase of t he researc h, we will e nr oll u ntil  6 9 H N C s ur vi v ors t o eac h of t he st u d y 
ar ms at N ort h well Healt h ( 3 4 i n t he c o ntr ol ar m a n d 3 5 i n t he i nter ve nti o n ar m)  c o m plete 
Ai m # 2 researc h pr oce d ures , i n or der t o c o ntri b ute t o t he o verall tar get accr ual of 1 3 8 
patie nts f or t he st u d y ( 6 9 fr o m N ort h well, 6 9 fr o m t he V A) . I n t he e ve nt t hat t he V A is 
u na ble t o e nr oll 6 9 H N C s ur vi v ors t o eac h of t he st u d y ar ms at t heir site, N ort h well will 
e nr oll a d diti o nal patie nts t o e ns ure t hat we meet t he o verall tar g et accr ual  f or t he st u d y.  
 
 
9.  S T U D Y TI M E LI N E S  
•  D escri be t he d ur ati o n of a n i n divi d u als p artici p ati o n i n t he st u dy  
•  D escri be t he d ur ati o n a ntici p ate d t o e nr oll all st u dy s u bjects  
•  T he esti m ate d d ate of st u dy c o m pleti o n  
 
Ai m 1  
Ai m 1 partici pa nts  ma y  be as ke d t o atte n d 3 -5  virt ual or i n -pers o n i nter vie ws t hat ma y  last 
u p t o 1 h o urs eac h. We a ntici pate we will c o n d uct Ai m 1 st u d y acti vities f or u p t o 6 
m o nt hs. T he esti mate d date of c o m pleti o n of t his ai m is S e pte m ber 1 , 2 0 23 . 
 
Ai m 2  
F or Ai m 2,  t otal st u d y d urati o n will be 6 m o nt hs f or all partici pa nts. All partici pa nts will 
be re q uire d t o c o m plete e nr oll me nt a n d baseli ne q uesti o n naires  a n d f oll o w-u p assess me nts 
at 3-m o nt hs a n d 6 -m o nt hs p ost -e nr oll me nt, w hic h will ta ke  1 h o ur  t o c o m plete. 
P artici pa nts ra n d o mize d t o recei ve tail ore d te xt messa ges will recei ve u p t o 3 messa ges , u p 
t o 3 ti mes a wee k f or t he first 3 m o nt hs  of t heir partici pati o n i n Ai m 2 . F or all partici pa nts, 
st u d y partici pati o n will be c o m plete after t he 6-m o nt h f oll o w -u p assess me nt . We esti mate 
t he date of c o m pleti o n of Ai m 2 t o be Marc h  3 1, 2 0 2 6.  

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 1 3  of 3 2  
 
 
1 0.   E N D P OI N T S  
•  D escri be t he pri m ar y a n d sec o n d ary st u dy e n d p oi nts  
•  D escri be a ny pri m ary or sec o n d ar y s afety e n d p oi nts  
 
F or  Ai m 1: O ur mai n e n d p oi nt is a ne w li brar y of te xt messa ges o n B ottle  C a p tail ore d t o 
hea d a n d nec k ca ncer s ur vi v ors , b ot h Ci vilia n a n d Vetera ns.  
 
F or Ai m 2: O ur pri mar y e n d p oi nt is alc o h ol cessati o n, a bi nar y varia ble  (dri n ki n g is 
occ urri n g or dri n ki n g is n ot occ urri n g)  create d base d o n data c ollecte d as part of t he Ti me -
Li ne F oll o w Bac k ( T L F B) pr oce d ure  a n d t he alc o h ol use dis or ders i de ntificati o n test 
( A U DI T). W hile b ot h T L F B a n d A U DI T will be use d t o c ollect data f or t his o utc o me, 
T L F B will be s u perse de t he A U DI T as t he pri mar y o utc o me meas ure if c o nflicti n g 
res p o nses are pr o vi de d. Feasi bilit y of c o n d ucti n g a f ut ure lar ge -scale effica c y R C T, 
defi n e d as a recr uit me nt rate of 7 0 % ( n u m ber of s ur vi v ors recr uite d o ver a p pr oac he d) i n 
t he pil ot R C T, will als o be assesse d as a pri mar y e n d p oi nt. O ur sec o n dar y e n d p oi nt is 
alc o h ol re d ucti o n  w hic h will be assesse d as a perce nt c ha n ge usi n g t he sa m e met h o ds  
descri be d a b o ve f or t he  pri mar y e n d p oi nt (i. e., T L F B a n d A U DI T ).  
 
O ur sec o n dar y o utc o mes are q ualit y of life ( meas ure d wit h t he Hea d a n d Nec k Q ualit y of 
Life i nstr u me nt, a wi del y use d 2 0 -ite m Li kert scale meas ure t hat e val uates q ualit y of life 
relate d t o eati n g, c o m m u nicati o n, pai n, a n d e m oti o n i n t he last 4 wee ks), o verall healt h 
( meas ure d wit h t he S F-1 2 Q uesti o n naire), de pressi o n ( meas ure d wit h t he P atie nt Healt h 
Q uesti o n naire ( P H Q -2 )) wit h a d diti o nal res o urces a n d li n ka ge t o care pr o vi de d, s ocial 
is olati o n ( meas ure d wit h t he L u b be n S ocial Net w or k Scale) a n d l o neli ness ( meas ure d wit h 
t he De J o n g Gier vel d L o neli ness S cale). A d diti o nall y, d uri n g o ur Ai m 2 pil ot R C T, we 
will e val uate acce pta bilit y of t he i nter ve nti o n, defi ne d as a p ositi ve e val uati o n of t he 
i nter ve nti o n as i n dicate d b y a mea n val ue of 4 o n a 5-p oi nt scale, wit h hi g her val ues = 
hi g her acce pta bilit y.  
 
 
1 1.   R E S E A R C H P R O C E D U R E S  
•  I ncl u de a det aile d descri pti o n of all pr oce d ures t o be perf or me d o n t he rese arc h 
s u bject a n d t he sc he d ule f or e ac h pr oce d ure. 
•  Incl u de a ny scree ni n g pr oce d ures f or eli gi bility a n d/ or b aseli ne di a g n ostic tests  
•  Incl u de pr oce d ures bei n g perf or m e d t o m o nit or s u bjects f or s afety or mi ni mize risks  
•  Incl u de i nf or m ati o n a b o ut dr u g w as h o ut peri o ds  
•  If dr u gs or bi ol o gics are bei n g a d mi nistere d pr ovi de i nf or m ati o n o n d osi n g a n d r o ute 
of a d mi nistr ati o n  
•  C le arly i n dic ate w hic h pr oce d ures are o nly bei n g c o n d ucte d f or rese arc h p ur p oses. 
•  If a ny s peci me ns will be use d f or t his rese arc h, ex pl ai n w het her t hey are bei n g 
c ollecte d s pecific ally f or rese arc h p ur p oses.   
•  D escri be a ny s o urce rec or ds t h at will be use d t o c ollect d at a a b o ut s u bjects  
•  In dic ate t he d at a t o be c ollecte d, i ncl u di n g l o n g ter m f oll o w -u p  
 
Ai m 1  

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 1 4  of 3 2  
T he st u d y tea m will w or k cl osel y wit h  t he H N C patie nt a d vis or y b oar d ( P A B) t o 
partici pate i n m ulti ple i nter vie ws ai me d t o a da pt a n e xisti n g alc o h ol cessati o n messa gi n g 
pr o gra m ( B ottle  Ca p) f or H N C s ur vi v ors base d o n t he O R BI T m o del. If nee de d, t he st u d y 
tea m will scree n t he E M R f or p ote ntial eli gi bilit y ((ty pe of H N C, date(s) of treat me nt, a ge, 
se x, race, a n d e d ucati o n, etc.) t o meet e nr oll me nt o bjecti ves. After c o nse nt  is o btai ne d, t he 
st u d y tea m will c ollect basic de m o gra p hic i nf or mati o n a n d ma y  as k partici pa nts t o 
partici pate i n 3 -5 i nter vie ws  eit her i n pers o n or via tele or vi de o c o nfere nce.  D uri n g t hese 
i nter vie ws, partici pa nts ma y  be as ke d t o gi ve q ua ntitati ve a n d q ualitati ve fee d bac k o n a set 
of te xt messa ges (see attac he d d oc u me nt) t hat ai m t o hel p pe o ple t o st o p dri n ki n g alc o h ol 
base d o n t heir o pi ni o ns re gar di n g t heir efficac y . I nter vie ws ma y be a u di o/ vis ual rec or de d 
t o e ns ure acc urac y. P artici pa nt are i nf or me d of t his i n t he c o nse nt d oc u me nt f or Ai m # 1.  
Base d o n i nter vie w  fee d bac k, we will select t he te xt messa ges t hat will be use d i n t he Ai m 
# 2 i nter ve nti o n.    
 
P artici pa nts  will als o be as ke d a b o ut t heir pers o nal e x perie nces i n or der t o create ne w 
messa ges.  O verall, we pla n t o a da pt 5 0 messa ges i n 3 -5 r o u n ds of a da ptati o n s pri nts. All 
ne wl y a da pte d messa ges will be i nc or p orate d i nt o B ottle Ca p’s messa ge li brar y . We will 
s u b mit a m o dificati o n if t he te xt messa ges differ si g nifica ntl y i n c o nte nt t ha n t h ose alrea d y 
create d a n d s u b mitte d f or re vie w, or if t he nat ure of t he q uesti o ns c o ul d c ha n ge t he 
ris k/ be nefit rati o i nitiall y d oc u me nte d b y t he I R B.  
 
P artici pa nts will be c o m pe nsate d u p t o $ 1 2 5  f or t heir partici pati o n i n Ai m 1; $ 1 2 5 will be 
e ve nl y di vi de d a m o n g t he t otal n u m ber of i nter vie ws nee de d t o c o m pe nsate partici pa nts f or 
t heir i n v ol ve me nt wit h eac h i nter vie w.  
 
 
Ai m 2  
All partici pa nts will be i nitiall y scree ne d via E M R rec or ds f or p ote ntial eli gi bilit y  (t y pe of 
H N C, date(s) of treat me nt, a ge, se x, race, a n d e d ucati o n , etc.). A wai ver of a ut h orizati o n 
f or t his access has bee n re q ueste d bel o w. St u d y staff will see k per missi o n t o a p pr oac h 
p ote ntial partici pa nts fr o m t he H N C s ur vi v or’s pr o vi der bef ore i n viti n g t he patie nt t o 
e xte n d a n e xisti n g sc he d ule d a p p oi nt me nt t o partici pate i n t he st u d y. At t he e n d of t he 
cli nic visit, t he H N C s ur vi v or will meet wit h t he st u d y staff t o o btai n  i nf or me d c o nse nt, 
sc he d ule a n ot her ti me t o disc uss t he st u d y or o btai n c o ntact i nf or mati o n t o se n d t he 
c o nse nt d oc u me nt  (i. e., via R E D Ca p or mail) . After c o nse nt, t he c o or di nat or will rec or d 
baseli ne data  a n d all assess m e nts.  P artici pa nts t hat are f o u n d t o ha ve cli nicall y si g nifica nt 
de pressi o n ( ≥ 1 6 o n t he C E S -D I o wa s h ort f or m) will be wit h dra w n fr o m t he st u d y a n d 
referre d t o s ocial w or k. 
 
C o nse nte d partici pa nts will  t he n be bl oc k -ra n d o mize d i nt o o ne of 2 ar ms:   
i. C o ntr ol c o n diti o n: Assess m e nt a n d Fee d b ac k ( A F) . Re gar dless 
of dri n ki n g le vel  ascertai ne d d uri n g t he baseli ne q uesti o n naires , 
t he patie nt will recei ve fee d ba c k a b o ut t heir re p orte d alc o h ol 
c o ns u m pti o n fr o m st u d y c o or di nat ors (i. e. n ot t hr o u g h B ottle  
C a p).  Fee d bac k will be pr o vi de d b y st u d y c o or di nat ors  o ne ti me,  
i n pers o n or virt uall y (de pe n di n g o n h o w t he partici pa nt elects t o 
recei ve t heir baseli ne visit), after t he baseli ne meas ures are 
c o m plete d , a n d i ncl u de assess me nt of alc o h ol le vels a n d 
rec o m me n di n g alc o h ol cessati o n. T he fee d bac k will e m p hasize 
t hat, acc or di n g t o lea di n g me dical ass ociati o ns, a n y c o ns u m pti o n 
of alc o h ol is n ot a d visa ble f or ca ncer s ur vi v ors, as c o nti n ue d 

Versi o n Date: 9 .9 .2 0 2 5  
P a ge 1 5  of 3 2  
alc o h ol use is ass ociate d wit h a hi g her ris k of ca ncer rec urre nc e 
a n d re d uce d q ualit y of life. A sa m ple fee d bac k state me nt is “ o ne 
or t w o dri n ks mi g ht n ot see m m uc h, b ut it ca n i ncrease y o ur 
c ha nces of ca ncer rec urr e nce ”. S m o ki n g cessati o n i nf or mati o n 
will als o be pr o vi de d  as per us ual care . P atie nts will be ur ge d t o 
st o p s m o ki n g a n d referre d t o a s m o ki n g cessati o n pr o gra m if s o 
desire d. P artici pa nts will be as ke d  t o c o m plete t w o f oll o w-u p 
q uesti o n naires, o ne at 3 a n d o ne at 6 m o nt hs p ost baseli ne, d uri n g 
sc he d ule d f oll o w -u p visits. N o f urt her eff ort will be re q uire d .  
ii. I nter ve nti o n c o n diti o n. S ur vi v ors recr uite d fr o m N W H w h o are
ra n d o mize d i nt o t he i nter ve nti o n c o n diti o n will recei ve all
resear c h acti vities gi ve n i n t he c o ntr ol c o n diti o n, pl us t he H N C -
tail ore d alc o h ol cessati o n pr o gra m.  St u d y staff will re gister t he
s ur vi v or at t he B ottle Ca p we bsite a n d c o nfir m t he pers o n’s
ge n der a n d a ge. S ur vi v ors will recei ve te xt messa ges t hree ti mes a
wee k, us uall y d uri n g t he late after n o o n/earl y e ve ni n g peri o d, w he n
t he ris k of alc o h ol dri n ki n g is greatest, f or a peri o d of 3 m o nt hs.
P artici pa nts will be a s ke d t o c o m plete t w o f oll o w-u p
q uesti o n naires, o ne at 3 a n d o ne at 6 m o nt hs p ost baseli ne. As
wit h t he c o ntr ol c o n diti o n ar m, all st u d y acti vities will e n d after 6
m o nt hs.
All partici pa nts will recei ve u p t o $ 1 0 0  c o m pe nsati o n at t he e n d of t he st u d y f or t heir 
partici pati o n i n Ai m 2.  
It s h o ul d be n ote d t hat partici pa nts will ha ve t he o pti o n of c o m pleti n g all assess me nts 
electr o nicall y (i. e., via R E D Ca p li n k), via har d c o p y (i.e., maile d f or m), a n d o ver t he p h o ne 
or i n -pers o n wit h t he C R C/ R A. I n t he e ve nt t hat partici pa nts o pt t o c o m ple te t he 
q uesti o n naire via maile d c o p y, o ver t he p h o ne or i n -pers o n, t he C R C/ R A will i n p ut 
partici pa nt res p o nses i nt o R E D Ca p. F or t his st u d y, a ll data c ollecte d will be c o de d a n d 
e ntere d i nt o R E D Ca p ( Researc h Electr o nic Data Ca pt ure), a vette d HI P A A c o m plia n t 
( Healt h I ns ura nce P orta bilit y a n d Acc o u nta bilit y Act) we b-base d a p plicati o n t hat ma na ges 
resear c h s ur ve ys a n d data bases. 
1 2. S T A TI S TI C A L A N A L Y SI S
•
Descri be h o w y o ur d at a will be use d t o test t he hy p ot heses.
•
St ate cle arly w h at v ari a bles will be teste d a n d w h at st atistic al tests will be use d.
•
I ncl u de s a m ple size c alc ul ati o ns.
•
If t his is a pil ot st u dy, st ate w hic h v ari a bles will be ex a mi ne d f or hy p ot hesis
ge ner ati o n i n l ater st u dies.
Ai m 1:  
All ne wl y a da pte d B ottle Ca p messa ges will be re vie we d b y t he P atie nt A d vis or y B oar d 
( P A B), w hic h c o nsists of at least 1 5 H N C s ur vi v ors fr o m N ort h well Healt h a n d 1 5 H N C 
s ur vi v ors fr o m t he V A, as well as 5 cli nicia ns ( o nc ol o gists, s ur ge o ns, n urses, etc.) w h o 
care f or H N C patie nts a n d s ur vi v ors. Me m bers of t he P A B will be as ke d t o rate, o n a 
yes/ n o bi nar y scale, w het her a messa ge is m oti vati n g a n d c o n vi nci n g. If 8 0 % of me m bers 

Versi o n Date: 9 .9 .2 0 2 5  
P a ge 1 6  of 3 2  
rate a messa ge o n a bi nar y scale as b ot h m oti vati n g a n d c o n vi nci n g it will be i ncl u de d i n 
t he messa ge ba n k. F urt her, d uri n g t he i n di vi d ual i nter vie ws wit h me m bers of t he P A B, we 
will c ollect q ualitati ve fee d bac k o n h o w best t o a da pt t he messa ges s o t he y ar e tail ore d t o 
H N C s ur vi v ors’ u ni q ue iss ues relate d t o alc o h ol use, as well as use la n g ua ge t hat res o nates 
wit h ci vilia ns or V A me m bers. Fee d bac k s u p p orte d b y ≥ 2 H N C s ur vi v ors will be 
i nte grate d i nt o t he te xt messa ges.  
Ai m 2:  
P o wer A n alysis:  
T he pr o p ose d recr uit me nt sa m ple size of 6 9 partici pa nts per ar m ( 1 3 8 partici pa nts 
t otal) is base d o n feasi bilit y a n d a vaila bilit y of res o urces d uri n g t he recr uit me nt 
ti me fra me, as esti mate d b y t he PI of t his st u d y. Ass u mi n g 1 5 % attriti o n, 
recr uit me nt of 69 partici pa nts per ar m will yiel d a n a nal ytic sa m ple size of 
a p pr o xi matel y 6 0 partici pa nts per ar m ( 1 2 0 partici pa nts t otal). O ne of t he mai n 
g oals of t his st u d y is t o esti mate t he cessati o n rate i n b ot h t he c o ntr ol ar m a n d 
i nter ve nti o n ar ms. T heref ore, i n Ta ble 1 we use d t w o sa m ple sizes t o calc ulate t he 
9 5 % e xact c o nfi de nce i nter vals ( CI) a n d wi dt hs/ precisi o n c orres p o n di n g t o f o ur 
cessati o n rates. T he li mits are de pe n de nt o n t he o bser ve d pr o p orti o n, b ut a sa m ple 
size of 6 0 per ar m will pr o d uce a t w o-si de d 9 5 % c o nfi de nce i nter val wit h a 
ma xi m u m wi dt h e q ual t o 2 5 % w he n t he sa m ple pr o p orti o n is as hi g h as 4 0 %.  
O ur sec o n dar y o bjecti ve will be t o c o m pare t he cessati o n rate of t he t w o ar ms t o 
o btai n a preli mi nar y effect size esti mate t o be use d i n f ut ure trials. Si nce t his 
a nal ysis will be use d f or e x pl orat or y, h y p ot hesis -ge nerati n g p ur p oses, we will n ot 
be p o were d  t o detect a differe nce ( yet t o be deter mi ne d) i n t he cessati o n rate 
bet wee n t he t w o ar ms i n t his pil ot st u d y.  
Of n ote, a f ull y p o were d st u d y wit h pr o p orti o ns of 2 0 % cessati o n i n t he c o ntr ol 
ar m a n d 3 0 % cessati o n i n t he i nter ve nti o n ar m w o ul d re q uire a sa m ple size of 2 9 4 
per ar m ( 2 -si de d al p ha = 0. 0 5, p o wer = 8 0 %). Ass u mi n g 1 5 % attriti o n, 
a p pr o xi matel y 3 4 6 partici pa nts  w o ul d nee d t o be recr uite d per ar m i n a f ull y 
p o were d st u d y. As rec o m me n de d i n p u blis he d literat ure, t he mi ni m u m sa m ple size 
re q uire me nts f or a pil ot st u d y are 1 0 % of t he f ull y p o were d st u d y, w hic h w o ul d be 
a p pr o xi matel y 3 5 partici pa nts per ar m base d o n t hese ass u m pti o ns. We ha ve 
c h ose n t o e xcee d t hese mi ni m u m re q uire me nts i n or der t o ha ve m ore c o nfi de nce i n 
t he pil ot st u d y’s ca pacit y f or testi n g all as pects of t he trial desi g n a n d esti mati n g 
effe cts.  
Ta ble 1. 9 5 % CI a n d wi dt h/ precisi o n of esti mati o n per ar m f or var yi n g rates.  
S a m ple size per ar m  
Cessati o n rate  
9 5 % CI  
9 5 % CI 
wi dt h  
6 0  
1 0 %  
1 0 % ( 4 %, 2 1 %)  
1 7 %  
6 0  
2 0 %  
2 0 % ( 1 1 %, 3 2 %)  
2 1 %  
6 0  
3 0 %  
3 0 % ( 1 9 %, 4 3 %)  
2 4 %  
6 0  
4 0 %  
4 0 % ( 2 8 %, 5 3 %)  
2 5 %  
6 9  
1 0 %  
1 0 % ( 4 %, 2 0 %)  
1 6 %  
6 9  
2 0 %  
2 0 % ( 1 2 %, 3 2 %)  
2 0 %  
6 9  
3 0 %  
2 3 % ( 2 0 %, 4 3 %)  
2 3 %  
6 9  
4 0 %  
2 4 % ( 2 9 %, 5 3 %)  
2 4 %  

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 1 7  of 3 2  
 
T his st u d y will i ncl u de descri pti ve a n d u ni variate a nal yses.  
 
Varia bles t o be use d i n t he mai n a nal yses (i ncl u di n g c o variates): We will c ollect data o n 
de m o gra p hics,  healt h hist or y a n d treat me nt t y pe, p h ysicia n cessati o n a d vice, o verall healt h, 
a n d alc o h ol use. A d diti o nall y, we will c ollect data o n acce pta bilit y of t he te xt -messa ge  
base d i nter ve nti o n a n d feasi bilit y of c o n d ucti n g a f ut ure  R C T of t he i nter ve nti o n. O ur  
pri mar y a nal yses will i n v ol ve a bi nar y meas ure of alc o h ol cessati o n  usi n g t he T L F B a n d 
A U DI T scales . I n or der t o facilitate a bi nar y meas ure, the A U DI T q uesti o n naire will be 
m o difie d t o i ncl u de bra nc hi n g l o gic t o n ot prese nt t he re mai ni n g q uesti o ns of t he 
q uesti o n naire t o partici pa nts s h o ul d t heir res p o nse t o t he first q uesti o n of “ H o w ofte n d o 
y o u ha ve a dri n k c o ntai ni n g alc o h ol? ” be “ ne ver”. t he T L F B will be s u perse de t he A U DI T 
as t he pri mar y o utc o me meas ure if c o nflicti n g res p o nses are pr o vi de d.  S ec o n dar y  
e x pl orat or y a nal yses will i n v ol ve meas ures of q ualit y of life, de pressi o n, s ocial is olati o n, 
a n d l o neli ness as well as perce nt c ha n ge of alc o h ol cessati o n . 
 
St atistic al A n alyses:  
S u m mar y scales of sta n dar dize d meas ures will be c o m p ute d. U ni variate a n d descri pti ve 
a nal yses will be perf or me d o n all c o nti n u o us o utc o me varia bles a n d, n or malizi n g a n d/ or 
varia nce sta bilizi n g tra nsf or mati o ns will  be c o n d ucte d. We will e xa mi ne t he data f or 
o utliers a n d use descri pti ve a n d i nfere ntial statistical tec h ni q ues  f or data c haracterizati o n. 
We will c o m pare differe nces bet wee n t he A F a n d i nter ve nti o n ar ms wit h a 2 x 2 c his q uare  
test o n t he pr o p orti o ns of cessati o n i n t he gr o u ps. I n a d diti o n, t he rate of cessati o n bet wee n 
ci vilia n a n d  Vetera n patie nts will be preli mi naril y e val uate d t hr o u g h a t -test or a nal ysis of 
varia nce pr oce d ur e.  
 
Str atific ati o n of d at a:  
P atie nts, w h o ha ve c o nse nte d t o partici pate, will be ra n d o mize d t o eit her t he  
i nter ve nti o n or t o t he c o m paris o n c o n diti o n (assess me nt a n d fee d bac k a b o ut alc o h ol use). 
T his pr oce d ure will  e ns ure t hat a n e ve n n u m ber of partici pa nts will be all ocate d t o t he t w o 
ar ms, a n d t hat e ve n n u m bers per  c o n diti o n acr oss sites (i. e., N ort h well a n d V A) are 
mai ntai ne d o verall. T he Q ua ntitati ve I ntelli ge nce tea m  will de vel o p a n d  i m ple me nt t he 
ra n d o mizati o n pr oce d ure, usi n g a sec ure, HI P A A-c o m plia nt, we b -base d a p plicati o n t hat 
all o ws i n vesti gat ors or t he researc h  c o or di nat or t o ra n d o mize s u bjects i nt o R C Ts, usi n g 
t heir pers o nal c o m p uter a n d all o ws f or m ultice nter,  stratifie d, a n d si n gle/ d o u ble bli n de d 
R C Ts, usi n g per m ute d bl oc ks.  
 
 
1 3.  S P E CI M E N B A N KI N G  
•  If s peci me ns will be b a nke d f or f ut ure rese arc h, descri be w here t he s peci me ns will be 
st ore d, h o w l o n g t hey will be st ore d, h o w t hey will be accesse d a n d w h o will h ave 
access t o t he s peci me ns 
•  List t he i nf or m ati o n t h at will be st ore d wit h e ac h s peci me n, i ncl u di n g h o w s peci me ns 
are l a bele d/c o de d  
•  Descri be t he pr oce d ures t o rele ase t he s peci me ns, i ncl u di n g:  t he pr ocess t o re q uest 
rele ase, a p pr ov als re q uire d f or rele ase, w h o c a n o bt ai n t he s peci me ns, a n d t he 
i nf or m ati o n t o be pr ovi de d wit h t he s peci me ns. 
 
N A  

Versi o n Date: 9 .9 .2 0 2 5  
P a ge 1 8  of 3 2  
1 4. D A T A M A N A G E M E N T A N D C O N FI D E N TI A LI T Y
•
Descri be t he d at a a n d s peci me ns t o be se nt o ut or receive d.  As a p plic a ble, descri be:
o
W h at i nf or m ati o n will be i ncl u de d i n t h at d at a or ass oci ate d wit h t he
s peci me ns ?
o
W here a n d h o w d at a a n d s peci me ns will be st ore d ?
o
H o w l o n g t he d at a will be st ore d ?
o
W h o will h ave access t o t he d at a ?
o
W h o is res p o nsi ble f or recei pt or tr a ns missi o n of d at a a n d s peci me ns ?
•
Descri be t he ste ps t h at will be t ake n t o sec ure t he d at a d uri n g st or a ge, use a n d
tr a ns missi o n.
T he researc h material c ollecte d will i ncl u de q ua ntitati ve a n d me dical rec or d a bstracti o n 
data  at t he ti me of scree ni n g . T he q ua ntitati ve a n d electr o nic me dical rec or d data will be 
c ollecte d s pecificall y f or t he pr o p ose d researc h pr oject. T he me dical c hart data is c ollecte d 
t o c o ntact t he patie nt at f oll o w-u p ti me p oi nts. Si g ne d  har d -c o p y i nf or me d c o nse nts will be 
ke pt i n a l oc ke d file ca bi net at  6 0 0 C o m m u nit y Dri ve, S uite 3 0 0 , Ma n hasset, N Y 1 1 0 3 0 . 
O nl y t he st u d y pers o n nel will ha ve access t o li n ks bet wee n s u bjects a n d s u bject i de ntities. 
Access t o t he N ort h well Healt h S hare P oi nt P HI dri ve  c o ntai ni n g electr o nic data is 
restricte d t o st u d y pers o n nel.  
Data will be c ollecte d t hr o u g h R E D Ca p ( Researc h Electr o nic Data Ca pt ure), a vette d  
HI P A A -c o m plia nt ( Healt h I ns ura nce P orta bilit y a n d Acc o u nta bilit y Act) we b -base d 
a p plicati o n t hat ma na ges researc h s ur ve ys a n d data bases. All data will be de -i de ntifie d 
pri or t o c o n d ucti n g a nal yses. O nl y t he  PI a n d I R B a p pr o ve d st u d y tea m will ha ve access t o 
t he li n ks t hat ca n ass ociate t he s u bject rec or d t o t he i n di vi d uals. T hese li n ks will be 
mai ntai ne d  i n R E D Ca p. S u bjects will  si g n a n i nf or me d c o nse nt f or m pri or t o parta ki n g i n 
t he st u d y t hat states t he p ote ntial ris k of l oss of c o nfi de ntialit y. T his ris k  will be miti gate d 
b y st ori n g data a p pr o priatel y, e ns uri n g o nl y st u d y pers o n nel ha ve  access t o t he data, a n d 
t hat t here are data use a gree me nts i n place bef ore data is s hare d. 
Researc h data a n d d oc u me ntati o n will be mai ntai ne d sec ur el y a n d st ore d i n R E D Ca p a n d o n 
N ort h well’s S hare P oi nt P HI dri ve a cc or di n g t o a p plic a ble r e g ulat or y r e q uire me nts ( P olic y 
1 0 0. 9 7 Rec or ds Rete nti o n a n d Destr ucti o n a n d G R 0 2 1 Rese ar c h Data O w ners hi p a n d 
Ma na ge me nt f or a d diti o nal i nf or mati o n).  
T he Pri nci pal  I n vesti gat or will meet wit h t he st u d y staff o n a re g ular basis t o e ns ure data 
acc ur ac y a n d pr ot oc ol a d here nce. T o e ns ure t he vali dit y a n d i nte grit y of st u d y data, t he PI 
will als o o versee all data ma na ge me nt res p o nsi bilities  acr oss b ot h sites . 
1 5. D A T A A N D S A F E T Y M O NI T O RI N G P L A N
A s pecific d at a a n d s afety m o nit ori n g pl a n is o nly re q uire d f or gre ater t h a n mi ni m al risk 
rese arc h.  F or g ui d a nce o n cre ati n g t his pl a n, ple ase see t he  G ui da nce D oc u me nt  o n t he 
H R P P we bsite . 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 1 9  of 3 2  
 
P art I –  t his p art s h o ul d be c o m plete d f or all st u dies t h at re q uire a D S M P.   
P art II –  T his p art s h o ul d be c o m plete d w he n y o ur st u dy nee ds a D at a a n d 
S afety M o nit ori n g B o ar d or C o m mittee  ( D S M B/ C) as p art of y o ur D at a a n d 
S afety M o nit ori n g Pl a n.   
 
Part I:  Ele me nts of t he Data a n d Safet y M o nit ori n g Pla n  
•   I n dic ate w h o will perf or m t he d at a a n d s afety m o nit ori n g f or t his st u dy.   
•  J ustify y o ur c h oice of m o nit or, i n ter ms of assesse d risk t o t he rese arc h s u bject’s 
he alt h a n d well bei n g.  I n st u dies w here t he m o nit or is i n de pe n de nt of t he st u dy st aff , 
i n dic ate t he i n divi d u al’s cre de nti als, rel ati o ns hi p t o t he PI, a n d r ati o n ale f or selecti o n 
•  List t he s pecific ite ms t h at will be m o nit ore d f or s afety (e. g. a dverse eve nts, pr ot oc ol 
c o m pli a nce, etc) 
•  I n dic ate t he fre q ue ncy at w hic h acc u m ul ate d s afety a n d d at a i nf or m ati o n (ite ms liste d 
i n # a b ove) will be revie we d by t he m o nit or (s) or t he D S M B/ C.   
•  W here a p plic a ble, descri be r ules w hic h will g ui de i nterr u pti o n or alter ati o n of t he 
st u dy desi g n.   
•  W here a p plic a ble, i n dic ate d ose selecti o n pr oce d ures t h at will be use d t o mi ni mize 
t oxicity. 
•  S h o ul d a te m p or ary or per m a ne nt s us pe nsi o n of y o ur st u dy occ ur, i n a d diti o n t o t he 
I R B, i n dic ate t o w h o m will y o u re p ort t he occ urre nce.   
 
O versi g ht Res p o nsi bilities:  
T he Pri nci pal I n vesti gat or ( PI) , Dr. Mic ha el Diefe n bac h, has o versi g ht res p o nsi bilit y f or 
t he c o n d uct of t his researc h. T he PI will s u per vise t he researc h, e ns ure t hat eac h i n di vi d ual 
e n ga ge d i n researc h is q ualifie d t o d o s o b y virt ue of e d ucati o n, trai ni n g a n d e x perie nce t o 
perf or m t he dele gate d tas k.  He will pr otect t he ri g hts, safet y a n d welfare of partici pa nts b y 
e ns uri n g t hat t he researc h is c o n d ucte d i n acc or da nce wit h all fe deral re g ulat or y 
re q uire me nts, state la w a n d N ort h well Healt h p olicies (i ncl u di n g I R B S O Ps) a n d wit h t he 
I R B-a p pr o ve d pla n, a n d is c o n d ucte d i n acc or da nce wit h t he I R B a p pr o ve d pla n, a n d 
e ns ure t he acc urac y, sec urit y a n d i nte grit y of t he resear c h data a n d data a nal ysis.  
  
M o nit ori n g Res p o nsi bilities:  
St u d y data are accessi ble at all ti mes  f or re vie w b y t he PIs a n d na me d c o-i n vesti gat ors.  
T he PI a n d c o -i n vesti gat ors will re vie w st u d y o n a m o nt hl y  basis. C o or di nat ors will be 
a ble t o m o nit or st u d y pr oce d ure a d here nc e t hr o u g h re m ote m o nit ori n g. A n y tec h nical 
iss ues wit h t he B ottle C a p messa gi n g will be a d dresse d directl y b y t he st u d y tea m a n d a 
de dicate d B ottle  C a p tec h nical a n d c ust o mer s u p p ort gr o u p.  
 
•  
Re p orta ble e ve nts ( u na ntici pate d pr o ble ms, de viati o ns, vi olati o ns, etc.) will be 
re vie we d b y t he PIs at eac h site a n d re p orte d t o t heir res pecti ve I R Bs i n a ti mel y 
ma n ner a n d i n acc or da nce wit h l ocal I R B P olic y.  
 
All e ve nts deter mi ne d t o be re p orta ble at t he c olla b orati n g V A site will be c o m m u nicate d 
t o t he N ort h well Healt h PI t o assess c ha n ges as/if nee de d t o t he researc h.  
 
I n a d diti o n t o re p orta ble e ve nts, de viati o ns will als o be m o nit ore d. De viati o ns ca n be t he 
res ults of acti o ns of t he partici pa nt or of t he st u d y tea m. F or e xa m ple, sit uati o ns i n w hic h 
t he i n vesti gat or faile d t o perf or m tests or e xa mi nati o ns as re q uire d b y t he pr ot oc ol or 
fail ures o n t he part of st u d y s u bjects t o c o m plete sc he d ule d visits as re q uire d b y t he 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 2 0  of 3 2  
pr ot oc ol, w o ul d be c o nsi dere d pr ot oc ol de viati o ns. Pr ot oc ol de viati o ns ca n be maj or or 
mi n or.  
  
M aj or Pr ot oc ol Devi ati o n:  A de viati o n t hat affects s u bject safet y, ri g hts, welfare or data 
i nte grit y. 
  
E xa m ples of maj or pr ot oc ol de viati o ns i ncl u de ( b ut are n ot li mite d t o):  
•  
Use of st u d y pr oce d ures n ot a p pr o ve d b y t he I R B  
•  
Fail ure t o re p ort u na ntici pate d pr o ble ms t o t he I R B a n d/ or s p o ns or  
•  
E nr oll me nt of s u bjects ( or use of t heir i de ntifia ble data) after I R B -a p pr o val of 
st u d y e x pire d 
  
Mi n or pr ot oc ol devi ati o n:  A de viati o n t hat d oes n ot affect s u bject safet y, ri g hts, welfare or 
data i nte grit y.  
  
E xa m ples of mi n or pr ot oc ol de viati o ns i ncl u de ( b ut are n ot li mite d t o):  
•  
De viati o ns fr o m t he a p pr o ve d st u d y pr oce d ure t hat d o n ot affect s u bject safet y or 
data i nte grit y  
•  
O mitti n g a n a p pr o ve d p orti o n of t he pr ot oc ol  
  
T he PIs will deter mi ne if a de viati o n is maj or or mi n or. Maj or pr ot oc ol de viati o ns will be 
re p orte d t o t he I R B wit hi n te n ( 1 0) w or ki n g da ys of disc o ver y. Mi n or pr ot oc ol de viati o ns 
will be re p orte d at t he ti me of c o nti n ui n g re vie w or c hec k -i n b y t he I R B. 
  
F or t his st u d y, researc h pr oce d ures ar e li mite d t o recei pt of te xt messa ges a n d c o m pleti o n 
of q uesti o n naires/s ur ve ys.  As s uc h, we d o n ot e x pect a d verse e ve nts ( A E) t o occ ur.  
H o we ver, if t he y d o, a d verse e ve nts will be re p orte d t o t he I R B per re p orti n g g u i deli nes, 
u nless t he y are attri b uta ble t o a me dicall y i n dicate d pr oce d ure ac c o m pa n yi n g partici pati o n 
i n t his pr ot oc ol.   N o n-seri o us a d verse e ve nts will n ot be re p orte d i n t he I R B at eac h 
occ urre n ce b ut will be re p orte d i n s u m mar y f or m at t he ti me of c o nti n ui n g re vie w a n d 
pr ot oc ol ter mi nati o n. S eri o us a d verse e ve nts will be re p orte d usi n g t he seri o us a d verse 
e ve nt re p ort f or m.  
 
Des pite all of o ur eff orts t o mai ntai n t he pri vac y a n d data sec urit y of o ur partici pa nt’s 
i nf or mati o n, u na ntici pate d pr o ble ms, s uc h as a st ole n c o m p uter ma y occ ur, alt h o u g h it is 
hi g hl y u nli kel y.  O H R P c o nsi ders u na ntici pate d pr o ble ms, i n ge neral, t o i ncl u de a n y 
i nci de nt, e x perie nce, or o utc o me t hat meets all of t he f oll o wi n g criteria: 
  
1.    u ne x pecte d (i n ter ms of nat ure, se verit y, or fre q ue nc y) gi ve n (a) t he researc h 
pr oce d ures t hat are descri be d i n t he pr ot oc ol -relate d d oc u me nts, s uc h as t he I R B-
a p pr o ve d resear c h pr ot oc ol a n d i nf or me d c o nse nt d oc u me nt; a n d ( b) t he c haracteristics 
of t he s u bject p o p ulati o n bei n g st u die d;  
2.    relate d or p ossi bl y relate d t o partici pati o n i n t he researc h; a n d  
3.    s u g gests t hat t he researc h places s u bjects or ot hers at a greater ris k of har m (i ncl u di n g 
p h ysical, ps yc h ol o gical, ec o n o mic, or s ocial har m) t ha n was pre vi o usl y k n o w n or 
rec o g nize d.  
  
U na ntici pate d pr o ble ms ca n be “acts of G o d”, p o wer fail ures, breac hes of c o nfi de ntialit y, 
l oss of st u d y data, etc. si nce t he y c o ul d ha ve a n a d verse effect o n st u d y s u bjects. 
  

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 2 1  of 3 2  
Rel ate d: A n e ve nt is “relate d” if it is li kel y t o ha ve bee n ca use d b y t he researc h 
pr oce d ures.  
  
Pr o b a bly/ P ossi bly Rel ate d:  A n e ve nt is c o nsi dere d t o be pr o ba bl y or p ossi bl y relate d t o 
t he researc h if t here is a greater t ha n 5 0 % c ha nce t hat t he e ve nt was ca use d b y t he st u d y 
pr oce d ures.  
  
S h o ul d a n u na ntici pate d e ve nt relate d t o t he researc h t hat e x p oses i n di vi d uals ot her t ha n 
t he researc h partici pa nts (e. g., i n vesti gat ors, researc h assista nts, st u de nts, t he p u blic, etc.) 
t o p ote ntial ris k, t he e ve nt will be re p orte d i n a ti mel y ma n ner b ut n ot m ore t ha n fi ve ( 5) 
w or ki n g da ys after disc o ver y b y t he PI.  
  
T he PIs, as well as t he I R B a n d ot her o versi g ht c o m mittees, ha ve t he a ut h orit y t o st o p or 
s us pe n d t he st u d y or re q uire m o dificati o ns. 
 
 
Part II:  Data a n d Safet y M o nit ori n g B oar d or C o m mittee  
 
 
•   W he n a p pr o pri ate, att ac h a descri pti o n of t he D S M B.   
•  Pr ovi de t he n u m ber of me m bers a n d are a of pr ofessi o n al ex pertise.   
•  Pr ovi de c o nfir m ati o n t h at t he me m bers of t he b o ar d are all i n de pe n de nt of t he st u dy.  
 
 
 
 
1 6.  WI T H D R A W A L O F S U B J E C T S  
•  Descri be  a ntici p ate d circ u mst a nces u n der w hic h s u bjects will be wit h dr a w n fr o m t he 
rese arc h wit h o ut t heir c o nse nt 
•  Descri be pr o ce d ures f or or derly ter mi n ati o n  
•  Descri be pr o ce d ures t h at will be f oll o we d w he n s u bjects wit h dr a w fr o m t he rese arc h, 
i ncl u di n g p arti al wit h dr a w al fr o m pr oce d ures wit h c o nti n ue d d at a c ollecti o n.   
 
Circ u msta nces i n w hic h partici pates ma y be wit h dra w n fr o m t he researc h wit h o ut t heir 
c o nse nt ma y i ncl u de t he f oll o wi n g:    
•  
fail ure t o f oll o w i nstr ucti o ns,  
•  
fail ure t o a d here t o sc he d ule d i n-pers o n or virt ual i nter vie ws ,  
•  
it is n ot i n t he partici pa nt’s best i nterest t o c o nti n ue o n t his st u d y, or  
•  
t he st u d y is st o p pe d.   
 
T his decisi o n ma y be ma de b y t he PIs, or t he I R B.    
 
P artici pa nts will be a ble t o wit h dra w fr o m t he st u d y at a n y ti me. T he c o nse nt f or m will 
ma ke e x plicit t o patie nts t hat t he y ma y disc o nti n ue t he st u d y at a n y ti me wit h o ut pe nalt y 
a n d wit h o ut prej u dice t o t heir me dical care.  
 
A n y s u bjects wit h dra w n fr o m t he researc h  will be i nstr ucte d t hat per t he c o nse nt f or m we 
ma y still use i nf or mati o n we ha ve alrea d y c ollecte d f or resear c h p ur p oses b ut will n ot 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 2 2  of 3 2  
c o nti n ue t o c ollect a n y f urt her data. T he s u bject will ha ve t heir i nf or mati o n re m o ve d fr o m 
a n y f ut ure c orres p o n de nce t hat was pla n ne d f or t he st u d y.  
 
 
1 7.  RI S K S T O S U B J E C T S  
•  Descri be a ny p ote nti al risks a n d disc o mf orts t o t he s u bject ( p hysic al, psyc h ol o gic al, 
s oci al, le g al, or ot her) a n d assess t heir likeli h o o d a n d seri o us ness a n d w het her si de 
effects are reversi ble. W here a p pr o pri ate, descri be alter n ative tre at me nts a n d 
pr oce d ures t h at mi g ht be a dv a nt a ge o us t o t he s u bjects.  
•  I ncl u de risks t o ot hers , like sex u al p art ners (if a p pr o pri ate) 
•  Disc uss w hy t he risks t o s u bjects are re as o n a ble i n rel ati o n t o t he a ntici p ate d be nefits 
a n d i n rel ati o n t o t he i m p ort a nce of t he k n o wle d ge t h at m ay re as o n a bly be ex pecte d 
t o res ults 
•  Descri be t he pr oce d ures f or pr ote cti n g a g ai nst or mi ni mizi n g a ny p ote nti al risks, 
i ncl u di n g risks t o c o nfi de nti ality, a n d assess t heir likely effective ness.   
 
T here is a sli g ht ris k t hat partici pa nts mi g ht be distresse d or u nc o mf orta ble w he n bei n g 
as ke d q uesti o ns a b o ut t heir ca ncer or dri n ki n g ha bits. All researc h pers o n nel wit h patie nt 
c o ntact will be trai ne d b y Dr. Diefe n bac h a n d t he C o -Is t o be vi gila nt a n d se nsiti ve t o 
e x pressi o ns of distress. All partici pa nts will be e nc o ura ge d t o c o ntact t he PI if a n y 
c o ncer ns arise.  
  
T he ris ks t o s u bjects are reas o na ble i n t hat t his is a mi ni mall y i n vasi ve st u d y, n o s u bject’s 
treat me nt will be altere d i n a n y wa y a n d t he o nl y p ote ntial ris k is t hat of distress wit h 
q uesti o ns bei n g as ke d w hic h t he y are free t o s ki p. T he ris ks are o ut wei g he d b y t he 
a ntici pate d be nefits a n d k n o wle d ge t o be gai ne d t hat ma y hel p H N C s ur vi v ors  i n a d diti o n 
t o pr o vi di n g s u bjects wit h e n ha nce d k n o wle d ge a n d a ware ness of t he ris ks of alc o h ol 
c o ns u m pti o n after ca ncer treat me nt.   
  
T he pr oce d ures t o pr otect s u bjects a gai nst or mi ni mize t he descri be d ris ks i n a d diti o n t o 
ris ks t o c o nfi de ntialit y i ncl u de all o wi n g partici pa nts t o s ki p or c h o ose n ot t o res p o n d t o a n y 
q uesti o ns t hat ma y ca use t he m distress. C o nfi de ntialit y will be pr otect e d b y e ns uri n g t hat 
all patie nt i nf or mati o n gat here d will be ke pt o n N ort h well’s sec ure d ser ver a n d i n 
pass w or d pr otecte d files t hat o nl y t he researc h tea m has access t o. F urt her, i nf or mati o n 
will o nl y be accesse d w he n nee de d a n d t he researc h tea m will be trai ne d t o e ns ure 
c o nfi de ntiall y a n d t he c orrect pr oce d ures w he n accessi n g a n d sa vi n g patie nt i nf or mati o n 
are use d.  
 
I n t he f ut ure, we ma y p u blis h res ults of t his st u d y o n data s hari n g we bsites (e. g., O pe n 
S cie nce Fra me w or k),  i n scie ntific j o ur nals, a n d ma y prese nt it at scie ntific meeti n gs. If we 
d o we will n ot i de ntif y t he s u bject.   All data i ncl u de d i n t he p u blicati o n will be de -
i de ntifie d. 
 
 
 
 
 
1 8.  R E S E A R C H R E L A T E D H A R M/I N J U R Y  

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 2 3  of 3 2  
•  Descri be t he av ail a bility of me dic al or psyc h ol o gic al res o urces t h at s u bjects mi g ht 
nee d as a res ult of a ntici p ate d pr o ble ms t h at m ay be k n o w n t o be ass oci ate d wit h t he 
rese arc h. 
•  If t he rese arc h is gre ater t h a n mi ni m al risk, ex pl ai n a ny me dic al tre at me nts t h at are 
av ail a ble if rese arc h -rel ate d i nj ury occ urs, w h o will pr ovi de it, w h at will be pr ovi de d, 
a n d w h o will p ay f or it.   
 
T his st u d y prese nts n o greater t ha n mi ni mal ris k t o partici pa nts, t h us researc h relate d 
har m/i nj ur y is n ot e x pecte d.   
 
P atie nts ma y be at ris k f or sli g ht e m oti o nal distress, w hic h mi g ht res ult fr o m bei n g as ke d 
q uesti o ns a b o ut pers o nal ca ncer a n d treat me nt e x perie nces. P artici pa nts will be i nf or me d 
d uri n g t he i nter vie w sessi o ns a n d at t he be gi n ni n g of t he assess me nt t hat p ote ntiall y 
se nsiti ve t o pics will be disc usse d a n d t hat t he y ma y s ki p a n y part t hat w o ul d ma ke t he m 
u nc o mf orta ble.  I n acc or da nce wit h M o nter ’s sta n dar d of care pr oce d ur es, a n y partici pa nt 
w h o e x presses distress  t hr o u g h o ut t he d urati o n of t his st u d y, f or a n y reas o n, will be 
referre d b y t he st u d y tea m  t o a lice nse d s ocial w or ker fr o m o ur i nstit uti on . P atie nts will  
als o  be referre d t o s ocial w or k if t he y are cli nicall y de presse d or f o u n d t o ha ve se vere 
s u bsta nce a b use, as e val uate d b y o ur baseli ne assess me nt of sta n dar dize d meas ures   
 
 
1 9.  P O T E N TI A L B E N E FI T T O S U B J E C T S  
 
•  E x pl ai n w h at be nefits mi g ht be derive d fr o m p artici p ati o n i n t he st u dy, n oti n g i n 
p artic ul ar t he be nefit over st a n d ar d tre at me nt (e. g. a o nce -a -d ay a d mi nistr ati o n 
i nste a d of f o ur ti mes a d ay, a n or al f or m ul ati o n over a n I V a d mi nistr ati o n).  
•  Als o st ate if t here are n o k n o w n be nefits t o s u bjects, b ut det ail t he v al ue of k n o wle d ge 
t o be g ai ne d 
 
 T his researc h is desi g ne d t o test t he acce pta bilit y of t his t y pe of i nter ve nti o n pr o gra m.  We 
als o wa nt t o test h o w well it w or ks s o we ca n tr y t his a p pr oac h wit h m ore pe o ple i n a 
lar ger researc h st u d y.  Beca use we are l o o ki n g at h o w well t his w or ks, partici pa nts ma y 
i n directl y be nefit fr o m lear ni n g m ore a b o ut alc o h ol a n d its effect o n ca ncer s ur vi v ors.  
I nf or mati o n we gat her fr o m partici pa nts’ res p o nses ma y hel p f ut ure ca ncer a n d H N C 
patie nts t o c ut d o w n (re d uce) t heir alc o h ol dri n ki n g.  
 
 
2 0.  P R O VI SI O N S T O P R O T E C T P RI V A C Y I N T E R E S T S O F S U B J E C T S  
 
•  Descri be t he met h o ds use d t o i de ntify p ote nti al rese arc h s u bjects, o bt ai n c o nse nt a n d 
g at her i nf or m ati o n a b o ut s u bjects t o e ns ure t h at t heir priv acy is n ot i nv a de d .  
•  I n a d diti o n c o nsi der priv acy pr otecti o ns t h at m ay be nee de d d ue t o c o m m u nic ati o ns 
wit h s u bjects (s uc h as p h o ne mess a ges or m ail).   
 
T he researc h ers ta ke t he iss ue of pri vac y  ver y seri o usl y. St u d y  i nf or mati o n will be st ore d 
i n a N ort h well-a p pr o ve d data base dri ve t o st ore P HI, a n d it will o nl y be accessi ble t o 
resear c h staff liste d o n t he a p pr o ve d I R B pr ot oc ol. Na mes or ot her i de ntif yi n g i nf or mati o n 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 2 4  of 3 2  
will n ot be s hare d wit h t h ose o utsi de t he researc h tea m, e xce pt as i n dicate d i n t he “ Data 
Ma na ge me nt a n d C o nfi de ntialit y” secti o n a b o ve f or t he p ur p oses of se n di n g researc h 
c o m m u nicati o ns. P h o ne n u m bers a n d e mail will o nl y be use d f or st u d y -relate d 
c o m m u ni cati o ns. A n y p h o ne calls or e mails will be se nt t o partici pa nts t hr o u g h t he 
res pecti ve st u d y site’s sec ure d ser ver a n d calls ma de at eac h st u d y l ocati o n i n a sec ure d 
area.  
 
 
 
 
2 1.   C O S T S T O S U B J E C T S  
 
•  Descri be  a ny f oresee a ble c osts t h at s u bjects m ay i nc ur t hr o u g h p artici p ati o n i n t he 
rese arc h 
•  I n dic ate w het her rese arc h pr oce d ures will be bille d t o i ns ur a nce or p ai d f or by t he 
rese arc h st u dy.   
 
T his  st u d y uses te xt messa gi n g t o deli ver  n otificati o ns, re mi n ders, a n d st u d y 
q uesti o n naires. C o m pleti n g t he s ur ve ys will re q uire cell ular data  if a partici pa nt is n ot  
c o n necte d t o  Wi -Fi.  Sta n dar d messa ge a n d data rates fr o m  t he partici pa nt’s wireless carrier 
ma y a p pl y. St u d y partici pa nts will n ot be  c o m pe nsate d f or a n y c osts relate d t o data usa ge 
or se n di n g or recei vi n g te xt messa ges b y t he st u d y or b y me m bers of t he st u d y tea m.   
If referre d f or c o u nseli n g or me dical care, the st u d y will n ot be res p o nsi ble f or a n y c osts 
ass ociate d f or f ut ure c o u nseli n g or me dical care nee de d b y partici pa nts.  
 
 
 
2 2.  P A Y M E N T T O S U B J E C T S  
 
•  Descri be t he a m o u nt of p ay me nt t o s u bjects, i n w h at f or m p ay me nt will be receive d 
a n d t he ti mi n g of t he p ay me nts.   
 
P atie nts partici pati n g o n t he a da ptati o n i nter vie ws  ( Ai m 1) will recei ve u p t o $ 1 2 5  f or t heir 
partici pati o n via a C li nC ar d deli vere d at t he e n d of Ai m 1 acti vities (i. e. all i nter vie ws are 
c o m plete). P atie nts partici pati n g i n t he pil ot  R C T ( Ai m 2) will recei ve u p t o $ 1 0 0  f or t heir 
partici pati o n  via a C li nC ar d u p o n c o m pleti o n of Ai m 2  assess me nt s ( $ 2 5 baseli ne, $ 2 5 3-
m o nt h, $ 5 0 6 -m o nt h) . 
 
 
2 3.   C O N S E N T P R O C E S S  
 
If o bt ai ni n g c o nse nt f or t his st u dy, descri be: 
•  W h o will be o bt ai ni n g c o nse nt  
•  W here c o nse nt will be o bt ai ne d  
•  A ny w aiti n g peri o d av ail a ble bet wee n i nf or mi n g t he pr os pective p artici p a nt a n d 
o bt ai ni n g c o nse nt  
•  Ste ps t h at will be t ake n t o ass ure t he p artici p a nts’ u n derst a n di n g  

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 2 5  of 3 2  
•  A ny t o ols t h at will be utilize d d uri n g t he c o nse nt pr ocess  
•    I nf or m ati o n a b o ut h o w t he c o nse nt will be d oc u me nte d i n writi n g.  If usi n g a  
st a n d ar d c o nse nt f or m, i n dic ate s uc h.   
•  Pr oce d ures f or m ai nt ai ni n g i nf or me d c o nse nt.   
 
Eac h s u bject will recei ve writte n e x pla nati o ns of t he p ur p oses, pr oce d ures, a n d ris ks of 
t his st u d y i n la n g ua ge a p pr o priate f or t he i n di vi d ual’s le vel of u n dersta n di n g. All 
q uesti o ns will be a ns were d via e mail or p h o ne, a n d if all i ncl usi o n criteria are me t, a n d 
t he s u bject v ol u nteers t o partici pate, di gital writte n i nf or me d c o nse nt will be o btai ne d.  
 
C o nse nt ma y be o btai ne d i n pers o n ( har dc o p y c o nse nt f or m) or electr o nicall y  ( writte n, 
electr o nic c o nse nt via R E D Ca p).  
 
F or i n  pers o n c o nse nt: T he site researc h c o or di nat ors, w h o ha ve e x perie nce o btai ni n g 
i nf or me d c o nse nt at N W H will descri be t he st u d y i n detail, a ns wer q uesti o ns, a n d 
o btai n writte n i nf or me d c o nse nt. T he st u d y i n vesti gat or or researc h c o or di nat or will 
n ot e nr oll a p ote ntial s u bje ct u ntil t he pers o n a d mi nisteri n g t he c o nse nt is satisfie d t hat 
t he s u bject u n dersta n ds all parts of t he st u d y. A c o p y of t he i nf or me d c o nse nt will be  
pr o vi de d t o t he patie nt at t he e n d of t he c o ns ultati o n pr ocess.  
 
F or e C o nse nt : T he e-c o nse nt d oc u me nt will c o ntai n all of t he ele me nts of i nf or me d 
c o nse nt re q uire d b y a p plica ble fe deral re g ulati o n f or t he pr otecti o n of h u ma n s u bjects 
a n d ele me nts of a ut h orizati o n re q uire d b y t he HI P A A Pri vac y R ule, a n d will be gi n 
wit h a c o ncise a n d  f oc use d prese ntati o n of t he ke y i nf or mati o n t hat is m ost li kel y t o 
assist partici pa nts i n u n dersta n di n g t he reas o ns w h y he/s he mi g ht or mi g ht n ot wa nt t o 
partici pate i n t he researc h. Beca use c o nse nt will be o btai ne d re m otel y, t he electr o nic 
c o nse nt f or m will be desi g ne d s uc h t hat t he f or m is eas y t o na vi gate. T he s yste m will 
als o i nc or p orate electr o nic strate gies t o e nc o ura ge partici pa nts t o access all of t he 
c o nse nt material bef ore d oc u me nti n g his/ her c o nse nt  via electr o nic si g nat ure .  
 
I n t he e ve nt a partici pa nt e x perie nces diffic ult y na vi gati n g o ur electr o nic c o nse nt f or m, 
t he st u d y tea m will mail a writte n c o p y of t he c o nse nt f or m t o t he partici pa nt . If t he 
partici pa nt a grees t o partici pate, t he y will be directe d t o si g n t he c o nse nt f or m a n d 
ret ur n bac k t o t he st u d y tea m. T his ca n be acc o m plis he d electr o nicall y (i. e., sca n ne d 
c o p y of c o nse nt f or m se nt t o t he st u d y tea m) or via mail (i. e., st u d y tea m pr o vi des 
sta m pe d ret ur n e n vel o pe f or partici pa nts t o mail bac k c o nse nt f or m).   
 
Researc h c o or di nat ors will re vie w na mes a n d si g nat ures of all c o m plete d c o nse nt 
f or ms. P D F c o pies of si g ne d c o nse nt f or ms will be st ore d i n a HI P A A-sec ure d, 
N ort h well a p pr o ve d st ora ge dri ve wit h pr otecte d access t o o nl y t he PI a n d researc h 
pers o n nel liste d  o n t he st u d y pr ot oc ol. A c o p y of t he si g ne d f or m will be ma de 
a vaila ble t o partici pa nts.  
 
P artici pa nts ma y c o ntact a me m ber of t he researc h tea m wit h q uesti o ns a b o ut t he 
resear c h. Eac h pa ge of c o nse nt materials will c o ntai n a direct n u m ber t o a researc h 
p h o ne a n d a desi g nate d e ncr y pte d e mail i n b o x. B ot h t he resear c h p h o ne a n d e mail 
i n b o x will be m o nit ore d dail y b y c o nse nti n g c o or di nat ors.  
 
 
 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 2 6  of 3 2  
 
I n t he st ate of N Y, a ny p artici p a nts u n der t he a ge of 1 8 are c o nsi dere d c hil dre n.  If y o ur 
st u dy i nv olves c hil dre n, a d diti o n al i nf or m ati o n s h o ul d be pr ovi de d t o descri be:  
•  H o w p are nt al per missi o n will be o bt ai ne d  
•  Fr o m h o w m a ny p are nts will p are nt al per missi o n be o bt ai ne d  
•  W het her per missi o n will be o bt ai ne d fr o m i n divi d u als ot her t h a n p are nts, a n d if 
s o, w h o will be all o we d t o pr ovi de per missi o n.  T he pr ocess us e d t o deter mi ne 
t hese i n divi d u al’s a ut h ority t o c o nse nt f or t he c hil d s h o ul d be pr ovi de d 
•  W het her or n ot asse nt will be o bt ai ne d fr o m t he c hil d  
•  H o w will asse nt be d oc u me nte d  
•  W het her c hil d s u bjects m ay be ex pecte d t o att ai n le g al a ge t o c o nse nt t o t he 
pr oce d ures f or res e arc h pri or t o t he c o m pleti o n of t heir p artici p ati o n i n t he 
rese arc h.  If s o, descri be t he pr ocess t h at will be use d t o o bt ai n t heir le g al 
c o nse nt t o c o nti n ue p a rtici p ati o n i n t he st u dy.  I n dic ate w h at will occ ur if c o nse nt 
is n ot o bt ai ne d fr o m t he n o w-a d ult s u bjects.   
 
N A  
 
 
If t he st u dy i nv olves c o g nitively i m p aire d a d ults, a d diti o n al i nf or m ati o n s h o ul d be 
pr ovi de d t o descri be:  
•  T he pr ocess t o deter mi ne w het her a n i n divi d u al is c a p a ble of c o nse nt  
•  I n dic ate w h o will m ake t his assess m e nt 
•  T he pl a n s h o ul d i n dic ate t h at d oc u me nt ati o n of t he deter mi n ati o n  a n d 
assess me nt will be pl ace d i n t he me dic al rec or d, w he n a p plic a ble, i n a d diti o n t o 
t he rese ar c h rec or d. 
•  If per missi o n of a le g ally a ut h orize d re pres e nt ativ e will be o bt ai ne d, 
o   list t he i n divi d u als fr o m w h o per missi o n will be o bt ai ne d i n or der of pri ority 
o  Descri be t he pr ocess f or asse nt of s u bjects; i n dic ate w het her asse nt will be 
re q uire d of all, s o me or n o ne of t he s u bjects.  If s o me, w hic h s u bjects will be 
re q uire d t o asse nt a n d w hic h will n ot. 
o  If asse nt will n ot be o bt ai ne d fr o m s o me or all s u bjects, pr ovi de a n 
ex pl a n ati o n as t o w hy n ot  
o  Descri be w het h er ass e nt will be d oc u me nte d a n d t he pr ocess t o d oc u me nt 
asse nt  
o  I n dic ate if t he s u bject c o ul d re g ai n c a p acity a n d at w h at p oi nt y o u w o ul d 
o bt ai n t heir c o nse nt f or c o nti n ue d p artici p ati o n i n t he st u dy  
 
N A  
 
 
If t he st u dy will e nr oll n o n-E n glis h s pe aki n g s u bjects:  
•  I n dic ate w h at l a n g u a ge(s) ot her t h a n E n glis h are u n derst o o d by pr os pectiv e 
s u bjects or re prese nt atives 
•  I n dic ate w het her or n ot c o nse nt f or ms will be tr a nsl ate d i nt o a l a n g u a ge ot her 
t h a n E n glis h 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 2 7  of 3 2  
•  Descri be t he pr ocess t o e ns ure t h at t he or al a n d writte n i nf or m ati o n pr ovi de d 
t o t h ose s u bjects will be i n t h at l a n g u a ge 
•  If n o n-E n glis h s pe aki n g s u bjects will be excl u de d, pr ovi de a j ustific ati o n f or 
d oi n g s o  
 
A pri mar y g oal f or t his pil ot researc h st u d y is t o test virt ual researc h 
deli ver y ca pa bilities a n d use of m o bile messa gi n g a n d c oac hi n g t o hel p 
H N C s ur vi v ors st o p a n d/ or re d uce dri n ki n g. T his st u d y b uil ds u p o n t he 
w or k ori gi nall y d o ne b y J o n M or ge nster n, P h. D. u n der pr ot oc ol 1 7 -0 3 9 0 
( B ottle Ca p) a n d is of hi g h si g nifica nce f or militar y a n d vetera n p o p ulati o ns 
f or w h o m b ot h alc o h ol dri n ki n g a n d H N C is ele vate d. H N C s ur vi v ors w h o 
c o nti n ue t o dri n k alc o h ol are at ris k f or p o or p h ysical a n d me ntal healt h 
o utc o m es, w hic h i m pe des missi o n rea di ness f or t he m a n d t heir fa mil y 
me m bers. We are f oc use d o n s oliciti n g fee d bac k fr o m partici pa nts o n t he 
ease of platf or m use, if t he researc h deli ver y was satisfact or y, if t he 
messa gi n g was dee me d usef ul, etc. C urre ntl y, B ottl e Ca p is a vaila ble i n 
E n glis h o nl y. Ha vi n g a platf or m ca pa ble of acc uratel y dis pla yi n g researc h 
re q uir e me nts a n d st u d y relate d material is es peciall y i m p orta nt f or s pea kers 
w h ose la n g ua ge i n v ol ves c haracters t hat ma y n ot be easil y dis pla ye d 
electr o nicall y or ma y i ntr o d uce f or matti n g err ors. We ai m t o be tr a ns pare nt 
t hat f urt her researc h is nee de d t o assess feasi bilit y i n t he sa me deli ver y wit h 
n o n -E n glis h s pea ki n g i n di vi d uals. Prese ntl y we h o pe t o c ollect e n o u g h 
i nf or mati o n t o j ustif y a f ut ur e e x pa nsi o n of t he B ottle Ca p pr o gra m t o ot her 
disease gr o u ps (e. g., hea d a n d nec k ca ncer patie nts or ot her at -ris k ca ncer 
patie nts). F u n ds f or s uc h a n e x pa nsi o n ca n t he n als o be use d t o e x pa n d t o 
S pa nis h. Please n ote t hat a si m ple tr a nslati o n of messa ges i nt o S pa nis h is  
n ot s ufficie nt t o ge nerate a n effecti ve alc o h ol cessati o n pr o gra m. Alc o h ol 
c o ns u m pti o n be ha vi or is tri g gere d b y c ult ural a n d i n di vi d ual fact ors, w hic h 
nee d t o be t h or o u g hl y e x pl or e d, bef ore te xt messa ges i n a n ot her la n g ua ge 
ca n be crafte d. He nce, t his re q uir es a s u bsta ntial i n vest me nt i n ti me a n d 
res o urces. Wit h re gar d t o t he c urre nt st u d y, we are a ware t hat  lac k of 
re prese ntati o n u n der mi nes ge neraliza ble res ults a n d i m pacts p u blic tr ust i n 
scie nce, t h us we are c o m mitte d t o e nr olli n g a raciall y a n d et h nicall y di verse 
p o p ulati o n i n t his pr ot oc ol. H o we ver, n ote t hat t he maj orit y of patie nts 
dia g n ose d wit h hea d a n d nec k ca ncer are W hite. We will ma ke all eff orts t o 
i ncl u de mi n orit y patie nts i nt o t he st u d y a n d we i nte n d t o a d vertise t he 
researc h wit h o ut restricti o n. Race a n d et h nicit y ( n ot j ust E n glis h 
pr oficie nc y) are str o n gl y c orrelate d wit h i nc o me, e m pl o y me nt, a n d ot her 
s ocial deter mi na nts of healt h, w hic h, b y defi niti o n, affect healt h o utc o mes 
a n d s uccess wit h alc o h ol cessati o n. We will c ollect i nf or mati o n o n all of 
t hese fact ors t o hel p i nf or m t he researc h desi g n. We d o n ot belie ve t hat 
f oc usi n g o n nati ve E n glis h-s pea ki n g partici pa nts i n t his pil ot st u d y - t h ose 
t hat ma y be fr o m et h nicall y a n d raciall y di verse p o p ulati o ns - will 
ne gati vel y i m pact e q uita ble a ccess, partici pa nt c o m pr e he nsi bilit y or 
a p plica bilit y t o  t he di verse p o p ulati o ns t hat ma y be s olicite d f or 
partici pati o n i n  f ut ur e cli nical trials usi n g B ottle Ca p. 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 2 8  of 3 2  
 
 
2 4.   W AI V E R O R A L T E R A TI O N O F T H E C O N S E N T P R O C E S S        
 N/ A           
 
C o m plete t his secti o n if y o u are see ki n g a n alter ati o n or c o m plete w aiver of t he c o nse nt   
pr ocess.  
•  Descri be t he p ossi ble risks of h ar m t o t he s u bjects i nv olve d i n t his st u dy a n d 
ex pl ai n w hy t he st u dy i nv olves n o m ore t h a n mi ni m al risk t o t he s u bject:   
•  E x pl ai n w hy t he w aiver/ alter ati o n will n ot a dversely affect t he ri g hts a n d welf are 
of s u bjects  
•  E x pl ai n w hy it is i m pr actic a ble t o c o n d uct t his rese arc h if i nf or me d c o nse nt is 
re q uire d   
•  E x pl ai n w hy it is n ot p ossi ble t o c o n d uct t his rese arc h wit h o ut usi n g t he 
i nf or m ati o n or bi os peci me ns i n a n i de ntifi a ble f or m 
•  If a p pr o pri ate, ex pl ai n h o w t he s u bjects will be pr ovi de d wit h a d diti o n al perti ne nt 
i nf or m ati o n after p artici p ati o n.   If n ot a p pr o pri ate t o d o s o, ex pl ai n w hy.  
 
 
 
C o m plete t his secti o n if y o u are o bt ai ni n g i nf or me d c o nse nt b ut y o u are re q uesti n g a 
w aiver of t he d oc u me nt ati o n of c o nse nt (i. e., ver b al c o nse nt will be o bt ai ne d ). T o 
pr ocee d wit h a w aiver b ase d o n t hese criteri a, e ac h s u bject m ust be aske d w het her t hey 
wis h t o h ave d oc u me nt ati o n li nki n g t he m t o t his st u dy.  O nly c o m plete s u bsecti o n 1 O R  
s u bsecti o n 2.  
 
  S U B S E C TI O N 1  
 
•  E x pl ai n h o w t he o nly rec or d li nki n g t he s u bject t o t he rese ar c h w o ul d be t he 
c o nse nt d oc u me nt.  
•  E x pl ai n h o w t he pri nci p al risk of t his st u dy w o ul d be t he p ote nti al h ar m res ulti n g 
fr o m a bre ac h i n t he c o nfi de nti ality 
•  In dic ate w het her or n ot s u bjects will be pr ovi de d wit h a writte n st ate me nt 
re g ar di n g t he rese arc h. 
 
  
 
S U B S E C TI O N 2  
•   Descri be t he p ossi ble risks of h ar m t o t he s u bjects i nv olve d i n t his st u dy a n d 
ex pl ai n w hy t he st u dy i nv olves n o m ore t h a n mi ni m al risk.   
•  C o nfir m t h at t he rese arc h o nly i nv olves pr oce d ure f or w hic h c o nse nt is n ot 
n or m ally re q uire d o utsi de t he rese arc h c o ntext.  
•  In dic ate w het her or n ot s u bjects will be pr ovi de d wit h a writte n st ate me nt 
re g ar di n g t he rese arc h. 
 
 
 
. 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 2 9  of 3 2  
 
2 5.  W AI V E R O F HI P A A A U T H O RI Z A TI O N  
 
 
 
 N/ A        
 
C o m plete t his secti o n if y o u see k t o o bt ai n a f ull w aiver of HI P A A a ut h oriz ati o n t o use 
a n d/ or discl ose pr otecte d he alt h i nf or m ati o n.  
•  Descri be t he ris ks t o priv acy i nv olve d i n t his st u dy a n d ex pl ai n w hy t he st u dy 
i nv olves n o m ore t h a n mi ni m al risk t o priv acy:   
•  Descri be  y o ur pl a n t o pr otect i de ntifiers fr o m i m pr o per use or discl os ure a n d t o 
dest r oy t he m at t he e arliest ti me. 
•   I n dic ate w hy it is n ot p ossi ble t o seek s u bjects’ a ut h oriz ati o n f or use or 
discl os ur e of P HI.  
•  I n dic ate w hy it is n ot p ossi ble t o c o n d uct t his rese arc h wit h o ut  use or discl os ure 
of t he P HI.   
•  I n dic ate if P HI will be discl ose d o utsi de N S LIJ He alt h Syste m, a n d if s o, t o w h o m.   
N ote:  P HI discl ose d o utsi de N S LIJ He alt h Syste m, wit h o ut HI P A A a ut h oriz ati o n 
nee ds t o be tr acke d. Ple ase see g ui d a nce at w w w. nslij. c o m/ir b  f or i nf or m ati o n 
a b o ut tr acki n g discl os ures.  
 
We re q uest a wai ver of a ut h orizati o n f or rec or d re vie w a n d scree ni n g p ur p oses 
o nl y f or b ot h Ai m # 1 a n d Ai m # 2.   
 
T he descri pti o n of t he P HI f or w hic h use or access is as f oll o ws: Patie nt, date of 
birt h ( D O B ), me dical rec or d n u m ber ( M R N ), Pr o vi der, Pr oce d ure, Pr oce d ure 
Date/ E nc o u nter Date , ca ncer t y pe, details, etc.  
 
C ollecti o n of t his i nf or mati o n is necessar y f or recr uit me nt/scree ni n g 
pr oce d ures.   T he use of t his  pr otecte d healt h i nf or mati o n i n v ol ves n o m ore 
t ha n a mi ni mal ris k t o t he pri vac y of i n di vi d uals, base d o n o ur a de q uate pla n t o 
pr otect t he i de ntifiers fr o m i m pr o per use a n d discl os ure as descri be d a b o ve.   
 
T he healt h i nf or mati o n c ollecte d f or t his recr uit me nt/scree ni n g p ur p ose will n ot 
be re use d or discl ose d t o a n y ot her pers o n or e ntit y, e xce pt as re q uire d b y la w, 
f or a ut h orize d o versi g ht of t he researc h st u d y. T he researc h c o ul d N O T 
practica bl y be c o n d ucte d wit h o ut t he wai ver or alterati o n f or 
eli gi bl y/r ecr uit me nt/scree ni n g. I n a d diti o n, t he researc h c o ul d N O T practica bl y 
be c o n d ucte d wit h o ut access t o a n d use of t he pr otecte d healt h i nf or mati o n.  
 
T he st u d y tea m is a ware t hat wai ver of a ut h orizati o n d oes n ot a ut h orize s u bject 
c o ntact. Treati n g  pr o vi ders  will be c o ns ulte d  pri or t o c o ntact. T he st u d y tea m is 
als o a ware t hat HI P A A re g ulati o ns re q uir e t hat acc o u nti n g l o gs be mai ntai ne d 
w he n researc hers access patie nt rec or ds u n der a wai ver of a ut h orizati o n 
i ncl u di n g t h ose a p pr o ve d f or recr uit me nt p ur p oses.   
 

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 3 0  of 3 2  
C o m plete t his secti o n if y o u see k t o o bt ai n a p arti al w aiver of t he p atie nt’s 
a ut h oriz ati o n f or scree ni n g/recr uit me nt p ur p oses  (i. e., t he rese arc her d oes n ot h ave 
access t o p atie nt rec or ds as s/ he is n ot p art of t he c overe d e ntity)  
N ote: I nf or m ati o n c ollecte d t hr o u g h a p arti al w aiver f or recr uit me nt c a n n ot be s h are d 
or discl ose d t o a ny ot her pers o n or e ntity.  
•  Descri be h o w d at a will be c ollecte d a n d use d:  
•  I n dic ate w hy y o u nee d t he P HI (e. g. P HI is re q uire d t o deter mi ne eli gi bility, 
i de ntifiers are necess ary t o c o nt act t he i n divi d u al t o disc uss p artici p ati o n, ot her) 
•  I n dic ate w hy  t he rese arc h c a n n ot pr actic a bly be c o n d u cte d wit h o ut t he p arti al 
w aiver (e. g. n o access t o me dic al rec or ds or c o nt a ct i nf or m ati o n of t he t ar gete d 
p o p ul ati o n, n o tre ati n g cli nici a n t o assist i n recr uit me nt of t he st u dy p o p ul ati o n, 
ot her)  
 
 
 
2 6.   V U L N E R A B L E P O P U L A TI O N S:  
 
I n dicate w het her y o u will i ncl u de a n y of t hese v ul nera ble p o p ulati o ns. If i n dicate d, 
s u b mit t he a p pr o priate a p pe n di x t o t he I R B f or re vie w: 
 
  C hil dre n or vi a ble ne o n ate  
  C o g nitively i m p aire d  
  Pre g n a nt W o me n, F et uses or ne o n ates of u ncert ai n vi a bility or n o nvi a ble  
  Pris o ners  
  N S LIJ E m pl oyees, resi de nts, fell o ws, etc  
  p o or/ u ni ns ure d  
  St u de nts  
  Mi n orities  
  El derly  
  He alt hy C o ntr ols  
 
If a ny of t hese p o p ul ati o ns are i ncl u de d i n t he st u dy, descri be a d diti o n al s afe g u ar ds t h at 
will be use d t o pr otect t heir ri g hts a n d welf are.  
 
Ai m 1 will e nr oll healt h care w or kers t o partici pate i n i nf or mati o nal i nter vie ws. 
P ote ntial  partici pa nts will be gi ve n d oc u me nts e x plai ni n g t hat partici pati o n i n t his 
researc h will n ot i m pact t heir e m pl o y me nt or sta n di n g wit h N ort h well Healt h. 
I n di vi d uals wit h a s u per vis or y relati o ns hi p o ver a n e m pl o yee will n ot e nr oll a n y 
i n di vi d ual w h o re p orts t o t he m i n t his st u d y. E m pl o yee partici pati o n or n o n-
partici pati o n i n t his st u d y will ha ve n o beari n g o n a n i n di vi d ual’s p ositi o n at N ort h well 
Healt h.    
 
 
2 7.   M U L TI -SI T E H U M A N R E S E A R C H ( C O O R DI N A TI N G C E N T E R)  
 

Versi o n Date: 9 .9 .2 0 2 5  
P a ge 3 1  of 3 2  
If t his is a m ulti-site st u dy w here y o u are t he le a d i nvesti g at or, descri be t he m a n a ge me nt 
of i nf or m ati o n (e. g. res ults, ne w i nf or m ati o n, u n a ntici p ate d pr o ble ms i nv olvi n g risks t o 
s u bjects or ot hers, or pr ot oc ol m o dific ati o ns) a m o n g sites t o pr otect s u bjec ts. 
T he ce ntral site i n vesti gat or, Mic hael A. Diefe n bac h, P h. D., is res p o nsi ble f or t he o verall 
o versi g ht of t he data c ollecte d at N W H a n d Br o o kl y n V A i n  a d diti o n t o t he m o nit ori n g of t he 
data, ass uri n g pr ot oc ol c o m plia nce, a n d c o n d ucti n g t he safet y re vie ws d uri n g re g ular meeti n gs 
or m ore fre q ue ntl y if nee de d. T he ce ntral site i n vesti gat or will als o be res p o nsi ble f or 
c o m pili n g t he data s heets, da y t o da y o versi g ht of researc h a n d e ns uri n g t he i nte grit y a n d 
pri vac y of t he data.  D uri n g t he re vie w pr ocess t he pr i nci pal i n vesti gat ors, al o n g wit h t he ot her 
i n vesti gat ors, will e val uate w het her t he st u d y s h o ul d c o nti n ue u nc ha n ge d, re q uire 
m o dificati o n/a me n d me nt, or be cl ose d t o e nr oll me nt. T o ai d i n t his st u d y pr o gress, data a n d 
safet y c o ncer ns will be re vie we d after e ver y m o nt h a n d will i ncl u de t he researc h tea m. O utsi de 
of t hese sc he d ule d meeti n gs, safet y c o ncer ns ca n be raise d at a n y ti me a n d b y a n y o ne. T he 
pri nci pal i n vesti gat ors or t he I nstit uti o nal Re vie w B oar d (I R B) ha ve t he a ut h orit y t o st o p or 
s us pe n d t he st ud y or re q uire m o dificati o ns.  
All researc h data i ncl u di n g a n y s u bject c o ntact i nf or mati o n a n d pr otecte d healt h i nf or mati o n 
o btai ne d b ot h fr o m t he baseli ne a n d f oll o w -u p meas ures will be hel d i n strict c o nfi de nce i n a 
c o de d f or mat, i de ntifie d o nl y b y a st u d y I D n u m ber. After data e ntr y, s u bject i nf or mati o n will 
n ot ha ve t he patie nt’s na me, b ut will be i de ntifie d o nl y b y a st u d y I D n u m ber. T he data base, 
t hat will be pass w or d-pr otecte d, st ore d, a n d bac ke d u p dail y o n a pr otect e d ser ver, will be 
desi g ne d usi n g R E D Ca p, a sec ure we b -base d a p p licati o n desi g ne d t o s u p p ort data ca pt ure f or 
resear c h st u dies. All data o btai ne d i n t he st u d y will be use d e xcl usi vel y f or t he p ur p oses of t he 
pr o p ose d researc h, w hic h are clearl y o utli ne d i n t he i nf or me d c o nse nt si g ne d b y t he patie nt. 
O n g oi n g pr otecti o n of c o nfi de ntialit y will be a d here d t o t hr o u g h o ut t he st u d y peri o d a n d 
t hereafter. I n a d diti o n, t he PI, Dr. Diefe n bac h will meet wit h t he st u d y staff at N W H o n a 
re g ular basis t o e ns ure data acc urac y a n d pr ot oc ol a d here nce. F urt her a n d as me nti o ne d pri or,  
meeti n gs wit h t he Br o o kl y n V A st u d y tea m will als o e ns ure pr ot oc ol a d here nce. T o e ns ure t he 
vali dit y a n d i nte grit y of st u d y data, Dr. Diefe n bac h will als o o versee all data ma na ge me nt 
res p o nsi bilities a n d will disc uss all data ma na ge me nt iss ues wit h t he st ud y tea m at b ot h sites.   
T he V A site will pr o vi de a c o p y of t he researc h data c ollecte d t o N ort h well  at t he c o ncl usi o n of 
t he st u d y.   
2 8. R E F E R E N C E S/ BI BI O G R A P H Y
Pr ovi de a re as o n a ble list of refere nces directly rel ate d t o t he st u dy. A ny di a gr a ms f or 
ne w me dic al devices or brief re pri nts fr o m j o ur n als mi g ht als o pr ove usef ul.  
1.  Marzilia n o, A., Tec kie, S., & Diefe n bac h, M. ( 2 0 2 0). Alc o h ol -relate d Hea d a n d Nec k 
Ca ncer: A S u m mar y of t he Literat ure. Hea d a n d Nec k, 4 2, 7 3 2 -7 3 8. A vaila ble fr o m: 
htt ps:// p u b me d. nc bi. nl m. ni h. g o v/ 3 1 7 7 7 1 3 1/  
2.
W ot ma n, M., Tec kie, S., Marzilia n o, A., Or ner, D., Yi, J., M ul va n y, C., G hal y, M.,
P aras har, B., & Diefe n bac h, M. ( 2 0 2 1). P atter ns of alc o h ol use a m o n g earl y hea d a n d
nec k ca ncer s ur vi v ors: A cr oss -secti o nal s ur ve y st u d y usi n g t he Alc o h ol Use Dis or ders
I dentificati o n Test ( A U DI T). Oral O nc ol o g y. A vaila ble fr o m:
htt ps:// p u b me d. nc bi. nl m. ni h. g o v/ 3 4 0 7 7 8 1 3/

Versi o n Date: 9 .9 .2 0 2 5   
 
P a ge 3 2  of 3 2  
3.  Mea d o ws, S. O., E n gel, C. C., C olli ns, R. L., Bec k ma n, R. L., Bresla u, J. Lit vi n Bl o o m, 
E., D u n bar, M. S., Gil bert, M., Gra nt, D., Ha wes -Da ws o n, J., Br o o ks H olli da y, S., 
Mac Cart h y, S., P e derse n, E. R., R o b bi ns, M. W., R ose, A.J., R ya n, J., S c hell, T. L., & 
Si m m o n s, M. M. ( 2 0 1 8). De part me nt of Defe nse Healt h Relate d Be ha vi ors S ur ve y 
( H R B S): Res ults f or t he Acti ve C o m p o ne nt. S a nta M o nica, C A: R A N D C or p orati o n. 
A vaila ble fr o m: htt ps:// w w w.ra n d. or g/ p u bs/researc h _re p orts/ R R 4 2 2 2. ht ml  
4.  M ue nc h, F., K. va n St ol k -C o o ke, A. K uer bis, G. Sta dler, A. Ba u mel, S. S ha o, J. R. 
Mc Ka y & M or ge nster n, J. ( 2 0 1 7). A Ra n d o mize d C o ntr olle d Pil ot Trial of Differe nt 
M o bile Messa gi n g I nter ve nti o ns f or Pr o ble m Dri n ki n g C o m pare d t o Wee kl y Dri n k 
Trac ki n g. P L o S O ne, 1 2, e 0 1 6 7 9 0 0. A vaila ble fr o m: 
htt ps:// p u b me d. nc bi. nl m. ni h. g o v/ 2 8 1 4 6 5 6 0/  
5.  Ze vall os J. P., Kra mer J. R., S a n d ulac he V. C., Massa, S. T., Hart ma n, C. M., Maz ul, 
A. L., Wa hle, B. M., Ger n dt, S. P., St ur gis, E. M, & C hia o, E. Y. ( 2 0 2 1). Nati o nal tre n ds 
i n or o p har y n geal ca ncer i nci de nce a n d s ur vi val wit hi n t he Vetera ns Affairs Healt h 
Care S yst e m. Hea d & Nec k. 2 0 2 1; 4 3: 1 0 8 – 1 1 5. A vaila ble fr o m: 
htt ps:// o nli neli brar y. wile y. c o m/ d oi/e p df/ 1 0. 1 0 0 2/ he d. 2 6 4 6 5