Development and evaluation of the usefulness, usability, and feasibility of iNNOV breast cancer

O iginal Pape De elopmen and E alua ion o he Use ulness, Usabili y, and Feasibili y o iNNOV B eas Cance : Mixed Me hods S udy C is ina Mendes-San os1,2,3,4, PhD; F ancisco Nunes5, PhD; Elisabe e Weide pass6, MSc, MD, PhD; Rui San ana3,4, PhD; Ge ha d Ande sson7,8,9, PhD 1Depa men o Cul u e and Socie y, Linköping Uni e si y, Linköping, Sweden 2Expe imen al Pa hology and The apeu ics G oup, Po uguese Ins i u e o Oncology, Po o, Po ugal 3Public Heal h Resea ch Cen e, NOVA Na ional School o Public Heal h, Uni e sidade No a de Lisboa, Lisbon, Po ugal 4Comp ehensi e Heal h Resea ch Cen e , Po ugal 5F aunho e Po ugal AICOS, Po o, Po ugal 6In e na ional Agency o Resea ch on Cance , Lyon, F ance 7Depa men o Beha iou al Sciences and Lea ning, Linköping Uni e si y, Linköping, Sweden 8Depa men o Biomedical and Clinical Sciences, Linköping Uni e si y, Linköping, Sweden 9Depa men o Clinical Neu oscience, Psychia y Sec ion, Ka olinska Ins i u e , S ockholm, Sweden Co esponding Au ho : C is ina Mendes-San os, PhD Depa men o Cul u e and Socie y Linköping Uni e si y Linköping, 581 83 Sweden Phone: 46 917890798 Email: [email p o ec ed] Abs ac Backg ound: Despi e he e icacy o psychosocial in e en ions in minimizing psychosocial mo bidi y in b eas cance su i o s (BCSs), in e en ion deli e y ac oss su i o ship is limi ed by physical, o ganiza ional, and a i udinal ba ie s, which con ibu e o a men al heal h ca e ea men gap in cance se ings. Objec i e: The aim o his s udy is o de elop iNNOV B eas Cance (iNNOVBC), a guided, in e ne -deli e ed, indi idually ailo ed, accep ance and commi men he apy–in luenced cogni i e beha io al in e en ion p og am aiming o ea mild o mode a e anxie y and dep ession in BCSs as well as o imp o e a igue, insomnia, sexual dys unc ion, and heal h- ela ed quali y o li e in his g oup. This s udy also aims o e alua e he use ulness, usabili y, and p elimina y easibili y o iNNOVBC. Me hods: iNNOVBC was de eloped using a use -cen e ed design app oach in ol ing i s p ima y and seconda y end use s, ha is, BCSs (11/24, 46%) and men al heal h p o essionals (13/24, 54%). We used mixed me hods, namely in-dep h semis uc u ed in e iews, labo a o y-based usabili y es s, sho - e m ield ials, and su eys, o assess iNNOVBC’s use ulness, usabili y, and p elimina y easibili y among hese a ge use s. Desc ip i e s a is ics we e used o cha ac e ize he s udy sample, e alua e pe o mance da a, and assess su ey esponses. Quali a i e da a we e eco ded, ansc ibed e ba im, and hema ically analyzed. Resul s: O e all, pa icipan s conside ed iNNOVBC highly use ul, wi h mos pa icipan s epo ing on he pe inence o i s scope, he digi al o ma , he ele an con en , and he app op ia e ea u es. Howe e , a ious usabili y issues we e iden i ied, and pa icipan s sugges ed ha he p og am should be e ined by simpli ying na iga ion pa hs, using a mo e dynamic colo scheme, including mo e icons and images, displaying in o ma ion in di e en o ma s and e sions, and de eloping sma phone and able e sions. In addi ion, pa icipan s sugges ed ha ables should be con e ed in o plain ex boxes and da a isualiza ion dashboa ds should be included o acili a e he acking o p og ess. The possibili y o using iNNOVBC in a lexible manne , ailo ing i acco ding o BCSs’changing needs and along he cance ca e con inuum, was ano he sugges ion ha was iden i ied. Conclusions: The s udy esul s sugges ha iNNOVBC is conside ed use ul by bo h BCSs and men al heal h p o essionals, con igu ing a p omising poin -o -need solu ion o b idge he psychological suppo i e ca e gap expe ienced by BCSs ac oss he su i o ship ajec o y. We belie e ha ou esul s may be applicable o o he simila p og ams. Howe e , o ul ill hei ull suppo i e ole, such p og ams should be comp ehensi e, highly usable, and ailo able and mus adop a lexible ye in eg a ed s uc u e capable o e ol ing in acco dance wi h su i o s’changing needs and he cance con inuum. JMIR Cance 2022 | ol. 8 | iss. 1 | e33550 | p. 1h ps://cance .jmi .o g/2022/1/e33550 (page numbe no o ci a ion pu poses) Mendes-San os e alJMIR CANCER XSL • FO Rende X (JMIR Cance 2022;8(1):e33550) doi: 10.2196/33550 KEYWORDS accep ance and commi men he apy; anxie y; b eas cance su i o s; cogni i e beha io al he apy; dep ession; digi al men al heal h; e-men al heal h; use -cen e ed design; in e ne in e en ions; usabili y; mobile phone In oduc ion Backg ound Since 2020, b eas cance has been he mos diagnosed cance wo ldwide and he leading cause o cance mo ali y in women. In Po ugal, as many as 7041 women a e diagnosed pe yea wi h b eas cance , and in 2020, a o al o 1864 women died owing o he condi ion [1,2]. Ne e heless, owing o imp o emen s in ea ly diagnosis, umo molecula cha ac e iza ion, and inno a i e sys emic ea men s, b eas cance p ognosis has signi ican ly imp o ed ac oss he globe, wi h 5-yea su i al a es eaching app oxima ely 90% in high-income coun ies [3]. In Po ugal, he 5-yea p e alence o b eas cance was es ima ed a 27,051 in 2020, making b eas cance su i o s (BCSs) he la ges g oup o cance su i o s in he coun y [1,2]. In spi e o a posi i e p ognosis, he su i o ship ajec o y is equen ly cha ac e ized by di icul ies associa ed wi h sequelae o cance and i s ea men and la e physical and psychosocial e ec s ha hinde BCSs’heal h- ela ed quali y o li e (HRQoL) [4]. Anxie y, dep ession [5,6], ea o ecu ence [7], a igue [8], sleeping p oblems [9], and sexual dys unc ion [10,11] a e among he mos common p oblems BCSs expe ience ac oss su i o ship and can mani es up o se e al yea s a e p ima y ea men comple ion [12]. In he pas decades, se e al in e en ions ha e been de eloped o minimize psychosocial mo bidi y in BCSs. Recen me a-analyses demons a ed he e icacy o such in e en ions in imp o ing a ange o psychosocial ou comes [13,14]. Cogni i e beha io al he apy (CBT) has been iden i ied as he mos e ec i e in e en ion o ea anxie y and dep ession in BCSs, o en showing signi ican small- o-mode a e ea men e ec s in pa ien s wi h hese condi ions [13,14]. O he psychosocial in e en ions such as psychoeduca ional ea men s [14], mind ulness-based in e en ions [15], and accep ance and commi men he apy (ACT) ha e been es ed among BCSs wi h success as well [16]. ACT, owing o i s model o heal hy adap a ion o di icul ci cums ances and ansdiagnos ic app oach, has been appoin ed as pa icula ly use ul in add essing he high le els o psychological and medical como bidi ies ha mani es in cance popula ions [17,18]. Reg e ably, he deli e y o such in e en ions ac oss he su i o ship ajec o y is limi ed owing o dis ance om heal h ca e se ices, heal h ca e sys em limi a ions, men al heal h illi e acy, and a i udinal ba ie s, all o which con ibu e o a men al heal h ca e ea men gap in cance se ings [19]. In e ne in e en ions—sel -help echnology-enabled in e en ions ha p o ide synch onous o asynch onous heal h- ela ed and men al heal h– ela ed assis ance based on es ablished psycho he apy models [20]—p o ide an oppo uni y o ul ill he men al heal h ca e gap wi hin oncology and o e BCSs wi h pa ien -cen e ed suppo a a dis ance. Ne e heless, despi e in e ne in e en ions’a es ed e icacy [21] in ea ing a ious men al heal h condi ions and i s po en ial cos -e ec i eness [22,23], in e ne in e en ions a ge ing cance su i o s a e scan [24]. Al hough p omising e ec s o such in e en ions ha e been documen ed conce ning anxie y, dep ession [25,26], dis ess [27], a igue [28], physical ac i i y [29], symp om managemen [30], insomnia [31,32], sexual dys unc ion [33], and quali y o li e [34,35], he o e all bene i o such in e en ions o BCSs is s ill unclea . Mos s udies in his domain epo on dissimila in e en ions o p esen high me hodological he e ogenei y, which makes hei compa ison di icul and inconsis en [30,36]. Mo eo e , in e en ions’ design p ocesses a e a ely epo ed, and he absence o e idence-based easoning behind i s de elopmen [36] con ibu es o a esea ch-p ac ice gap in he in e ne in e en ions domain, whe ein e idenced-based ea men s s uggle o be adop ed in ou ine ca e [37]. Ano he cause o he low up ake o in e ne in e en ions in clinical se ings is he pe iphe al posi ion end use s a e o en e e ed o du ing de elopmen [38]. In e en ion p og ams a e equen ly planned by neglec ing end use s’ pe spec i e (eg, indi idual’s goals, needs, skills, and con ex s) and esea che s o en ail o in ol e end use s in he de elopmen p ocess [37,38]. This lack o human-cen e edness in he de elopmen pa ly explains he high a i ion a es and poo engagemen o en epo ed in clinical ials and con igu es a limi a ion ha needs o be add essed o e ec i ely impac su i o ship suppo i e ca e p o ision [39,40]. The aim o his s udy is o epo on he de elopmen , use ulness, usabili y, and p elimina y easibili y o iNNOV B eas Cance (iNNOVBC), a guided, in e ne -deli e ed, indi idually ailo ed, ACT-in luenced CBT p og am de eloped o ea mild o mode a e anxie y and dep ession in BCSs, as well as o imp o e a igue, insomnia, sexual dys unc ion, and HRQoL in his g oup. Besides in o ming iNNOVBC’s u he de elopmen and e inemen , he con ibu ion o his pape esides in he desc ip ion o men al heal h p o essionals’(MHPs’) and BCSs’ pe spec i es on he use o digi al echnology o suppo cance su i o s and he design implica ions ha a ise om conside ing hese. iNNOVBC O e iew iNNOVBC (Figu es 1 and 2) is a guided, in e ne -deli e ed, indi idually ailo ed, ACT-in luenced CBT p og am and was de eloped wi h a use -cen e ed design app oach [37]. The p og am was c ea ed o add ess he psychosocial needs o BCSs ha we e p e iously iden i ied ia li e a u e e iew, namely, anxie y, dep ession, a igue, insomnia, sexual dys unc ion, and HRQoL. The in e en ion s uc u e and con en build up on p io CBT- and ACT-inspi ed in e en ions de eloped by he Depa men o Beha iou al Sciences and Lea ning a Linköping Uni e si y, a ge ing o he popula ions [41-45]. The applicable JMIR Cance 2022 | ol. 8 | iss. 1 | e33550 | p. 2h ps://cance .jmi .o g/2022/1/e33550 (page numbe no o ci a ion pu poses) Mendes-San os e alJMIR CANCER XSL • FO Rende X p e iously a ailable con en was ansla ed om Swedish and English o Po uguese and e iewed by ex e nal expe s (ie, an oncologis , a nu se, a psychologis , and a BCS). Addi ional con en was de eloped based on pee - e iewed sou ces [46-50], as well as mixed me hods esea ch conduc ed by he esea ch eam and in ol ing iNNOVBC’s p ima y and seconda y end use s [51,52]. iNNOVBC is composed o 10 ea men modules (Mul imedia Appendix 1), namely, i e manda o y modules (li ing wi h b eas cance and beyond, dep ession, anxie y, elaxa ion, and key poin s summa y, and planning o he u u e) and i e op ional modules (beha io al ac i a ion pa s I and II, sleep a igue, and in e pe sonal ela ionships, sex, and in imacy), o be comple ed in 10 weeks. An in oduc o y module p o ides gene al in o ma ion abou he p og am. Each module is designed o be comple ed in app oxima ely 60 minu es and includes w i en ex , images, ideos, audio iles, quizzes, ACT- and CBT-based exe cises, homewo k assignmen s, and espec i e wo kshee s. The p og am adop s a ansdiagnos ic s uc u e, ea u ing psychoeduca ion, accep ance, cogni i e de usion, connec ing wi h alues, commi ed ac ion, exposu e, beha io al ac i a ion, and elaxa ion as cen al componen s. Sleep managemen , ene gy conse a ion, p oblem sol ing, and sensa e ocusing echniques a e complemen a y componen s o he p og am. To gua an ee op imal use o he p og am, he s udy in e en ion was de eloped acco ding o he ollowing pe suasi e sys em p inciples ca ego ized by Oinas-Kukkonen and Ha jumaa [53]: esponsi eness, unneling, ailo ing, pe sonaliza ion, eminde s, and p o essional suppo . A he onse o he in e en ion, BCSs using he p og am should ailo hei ea men wi h he suppo o hei assigned he apis and acco ding o hei baseline assessmen and p e e ences. Once hey each an ag eemen , he selec ed modules should be p esc ibed and made a ailable weekly o he BCSs. Then, BCSs a e p omp ed o comple e he modules in app oxima ely 1 week. Wi hin 24 hou s o module comple ion, he he apis s assess he BCSs’ p og ess based on he epo ed ou comes and de e mine whe he hey should p oceed o he nex module. When a new module is made a ailable, BCSs ecei e an email no i ying hem. I no , he apis s should ins uc hem on wha needs o be comple ed o be able o ad ance o he nex module. In eg a ed 2-way communica ion ea u es such as email, cha , SMS ex messaging, and ideocon e ence suppo he in e en ion. The p og am is deli e ed ia iTe api, a web-based ea men pla o m de eloped a Linköping Uni e si y [54]. Figu e 1. The landing page o he iNNOV B eas Cance p og am. JMIR Cance 2022 | ol. 8 | iss. 1 | e33550 | p. 3h ps://cance .jmi .o g/2022/1/e33550 (page numbe no o ci a ion pu poses) Mendes-San os e alJMIR CANCER XSL • FO Rende X Figu e 2. The in oduc o y and 10 ea men modules o he iNNOV B eas Cance p og am. Me hods S udy Design Mixed me hods (Figu e 3), namely in-dep h semis uc u ed in e iews, usabili y es s, sho - e m ield ials, and su eys, we e combined o ul ill he ollowing speci ic goals: (1) e alua e iNNOVBC’s use ulness, (2) assess iNNOVBC’s usabili y, and (3) explo e iNNOVBC’s pe cei ed easibili y and accep abili y among i s a ge use s. The s udy was app o ed by he e hical commi ees o Ins i u o Po uguês de Oncologia do Po o, F ancisco Gen il, EPE; Cen o Hospi ala Uni e si á io do Po o; Cen o Hospi ala São João; Unidade Local de saúde–Ma osinhos; Hospi al CUF Po o; O dem dos Psicólogos Po ugueses; and he Po uguese Da a P o ec ion Commi ee (app o al numbe : 10727/2017). W i en in o med consen was ob ained om all pa icipan s. JMIR Cance 2022 | ol. 8 | iss. 1 | e33550 | p. 4h ps://cance .jmi .o g/2022/1/e33550 (page numbe no o ci a ion pu poses) Mendes-San os e alJMIR CANCER XSL • FO Rende X Figu e 3. S udy design. BCS: b eas cance su i o ; iNNOVBC: iNNOV B eas Cance ; MHP: men al heal h p o essional. Sampling and Rec ui men The s udy a ge ed BCSs and MHPs, who a e iNNOVBC’s p ima y and seconda y end use s. Eligibili y c i e ia o BCSs consis ed o women, aged >18 yea s, wi h a his o y o his ologically con i med b eas cance , who had comple ed p ima y adju an ea men (excep ho monal he apy), and we e capable o eading and w i ing in Po uguese. MHPs we e egis e ed psychologis s o psychia is s, capable o eading and w i ing in Po uguese. A nonp obabilis ic sample o BCSs and MHPs was ec ui ed ollowing e e als om he esea che s and p o essionals wo king a ea men cen e s in Po o (Po ugal) and ia snowball sampling. Pa icipan s we e pu posi ely sampled o di e si y in age, academic deg ee, and digi al echnology p o iciency. A o al o 28 MHPs and 16 BCSs we e in i ed o pa icipa e in he s udy in pe son, ia email, o by elephone. O he in i ed indi iduals, 54% (15/28) o he MHPs and 88% (14/16) o he BCSs ag eed o pa icipa e. Meaning sa u a ion was used as a s opping c i e ion, which mean ha new pa icipan s would no be en olled once no el ieldwo k insigh s s opped changing analysis signi ican ly [55]. Da a collec ion ended a e 87% (13/15) o he MHPs and 69% (11/16) o he BCSs comple ed he esea ch p o ocol, as meaning sa u a ion was eached du ing he las in e iews and usabili y es s. Da a Collec ion P ocedu es Da a we e collec ed be ween No embe 2019 and Feb ua y 2020 (ie, be o e he COVID-19 pandemic). Up o 2 o 3 in e iewe s o mode a o s (CMS, Ana Al es, and Elsa Oli ei a) pa icipa ed in da a collec ion. The esea ch p o ocol included an explo a o y semis uc u ed in e iew (N=24; ie, 11/24, 46% BCSs and 13/24, 54% MHPs; Mul imedia Appendix 2), a labo a o y-based usabili y es (Mul imedia Appendix 3), ollowed by he comple ion o a sel - epo ed usabili y su ey [56] (N=24; ie, 11/24, 46% BCSs, and 13/24, 54% MHPs), and a deb ie ing pos usabili y es in e iew (N=24; ie, 11/24, 46% BCSs, and 13/24, 54% MHPs; Mul imedia Appendix 4). The explo a o y in e iew aimed o in es iga e he use ulness o iNNOVBC and ga he equi emen s o u he e inemen o he p og am. The usabili y es assessed he pa icipan s’ pe o mance while execu ing a se ies o ep esen a i e p ede ined asks on dis inc pa s o he pla o m. The hink-aloud p o ocol was implemen ed o enable pa icipan s o oice hei hough s and issues [57]. The deb ie ing in e iew ocused on pa icipan s’ expe ience wi h using he pla o m, issues hinde ing hei expe ience, and changes o be pe o med o achie e be e e ec i eness, e iciency, and sa is ac ion wi h he p og am. These ac i i ies occu ed in pe son a F aunho e Po ugal–Cen e o Assis i e In o ma ion and Communica ion Solu ions mee ing ooms. Pa icipan BCSs willing o u he assess iNNOVBC we e in i ed o pa icipa e in an addi ional 2-week ield ial (8/11, 73% BCSs; Mul imedia Appendix 5) JMIR Cance 2022 | ol. 8 | iss. 1 | e33550 | p. 5h ps://cance .jmi .o g/2022/1/e33550 (page numbe no o ci a ion pu poses) Mendes-San os e alJMIR CANCER XSL • FO Rende X mimicking he expe ience o using he p og am, and o ill ou a su ey h ough he pla o m on he pe cei ed use ulness and easibili y o he p og am (Mul imedia Appendix 6). In e iews and usabili y es s we e audio and ideo eco ded, espec i ely. App oxima ely 36 hou s o audio eco dings and 9 hou s o ideo eco dings we e c ea ed. The a e age du a ion o p e es in e iews was 49 minu es ( ange 26-81 minu es) o MHPs and 74 minu es o BCSs ( ange 39-106 minu es). Usabili y es s we e comple ed on a e age in 20 minu es and ollowed by 28 minu es ( ange 10-46 minu es) o deb ie ing in e iews. In e iew eco dings we e ansc ibed e ba im (CMS and Ana Al es) in pa allel o da a collec ion, using oT ansc ibe (c ea ed by Ellio Ben ley; a p ojec o he MuckRock Founda ion) [58]. Usabili y es s we e assessed using p ede eloped obse a ion g ids and by egis e ing pa icipan s’ oiced ema ks. Da a we e s o ed in a pseudoanonymized o ma in a secu e passwo d-p o ec ed loca ion. Measu es Clinical, Sociodemog aphic, and In e ne -Rela ed Cha ac e is ics Backg ound ques ionnai es ailo ed o each a ge g oup collec ed clinical, sociodemog aphic, and in e ne - ela ed cha ac e is ics. BCSs we e inqui ed abou age, gende , educa ion le el, ma i al s a us, occupa ion, p o essional s a us, dis ance be ween esidence and ea men cen e , ime since diagnosis, ype o ea men pe o med, su i o ship s a us, p o iciency using digi al echnology, and expe ience in using digi al men al heal h (DMH) p og ams. MHPs we e inqui ed abou age, gende , educa ion le el, ma i al s a us, occupa ion, p o essional s a us, wo k con ex , p o essional expe ience (in yea s), heo e ical o ien a ion, p o iciency in using digi al echnology, and expe ience in using DMH p og ams. Use ulness Semis uc u ed in e iew guides (Mul imedia Appendix 2) we e de eloped based on a li e a u e e iew o assess pa icipan s’ pe cei ed use ulness o he p og am. The in e iew guides co e ed he ollowing domains: (1) su i o ship main challenges, unme ca e needs, and sel -ca e s a egies de eloped o add ess hose challenges and needs; (2) he p o ision o psychosocial su i o ship ca e o BCSs and he main ba ie s impac ing i ; (3) knowledge and use o DMH; and (4) a i udes owa d DMH p og ams aimed a p o iding su i o ship suppo . In addi ion, a ques ionnai e de eloped o assess he quali y o iNNOVBC’s ea men modules was used o his pu pose (Mul imedia Appendix 6). Usabili y We conduc ed usabili y es s and analyzed he pe o mance and accep ance o he sys em. To assess pe o mance, ask analysis was conduc ed and he numbe o comple ed asks, e o s, and assis ances we e eco ded in obse a ion g ids (Mul imedia Appendix 3). Accep ance was measu ed using he Po uguese e sion o he Sys em Usabili y Scale [56], whe e a sco e <68 is conside ed below a e age. The deb ie ing in e iews also in o med abou accep ance and con ibu ed o iden i ying con en and design changes o be pe o med o imp o e use expe ience and sa is ac ion (Mul imedia Appendix 4). Feasibili y The p elimina y easibili y o he p og am was assessed ia deb ie ing semis uc u ed in e iews and assessmen ques ionnai e in iNNOVBC’s ea men modules (Mul imedia Appendix 6). The pa icipan BCSs who used he sys em a home also p o ided w i en commen s. Analysis A combina ion o quan i a i e and quali a i e me hods was applied o assess iNNOVBC’s use ulness, usabili y, and pe cei ed easibili y. Desc ip i e s a is ics, namely, coun s, pe cen ages, medians, and IQRs, we e used o cha ac e ize he s udy sample, e alua e pe o mance da a, and assess p e e ence da a collec ed ia he Sys em Usabili y Scale and he ea men modules’assessmen ques ionnai e. No e iciency me ics we e compu ed because he hink-aloud me hod was applied. Mic oso Excel was used o compu e quan i a i e a iables. Quali a i e da a esul ing om he in e iews and BCSs’w i en commen s we e ansc ibed e ba im and analyzed using he hema ic analysis me hod o B aun and Cla ke [59]. Fi s , a deduc i e app oach was adop ed based on h ee p ede e mined high-le el hemes: use ulness, usabili y, and easibili y. Subsequen ly, induc i e analysis was pe o med on he da a collec ed wi hin hose hemes, and salien sub hemes we e coded. Ini ial coding was pe o med by he i s au ho (CM). Regula discussions we e p omo ed be ween esea che s (CMS and FN) o discuss esul s and coding ees. Da a pa e ns we e hen iden i ied and i e a i ely o ganized (CMS and FN) un il consensus be ween esea che s was achie ed and no addi ional insigh s we e esul ing om he analysis o he da a. Sc i ene so wa e [60] was used o suppo he coding p ocess. Resul s Pa icipan s’Cha ac e is ics The sample comp ised 24 pa icipan s (Table 1), including 11 (46%) BCSs and 13 (54%) MHPs. The median age o BCSs was 48 yea s (IQR 14; minimum 32, maximum 68). Mos su i o s we e ma ied (7/11, 64%) and college-educa ed (7/11, 64%). App oxima ely 55% (6/11) o he su i o s we e p o essionally ac i e. Mos BCSs had been ea ed wi h su ge y (11/11, 100%), chemo he apy (9/11, 82%), adio he apy (8/11, 73%), and ho monal he apy (9/11, 82%). Conside ing he su i o ship s a us [61], he sample was he e ogeneous, including pa icipan s a acu e (2/11, 18%), ex ended (3/11, 27%), and pe manen (6/11, 55%) su i o ship s ages. No pa icipan had p e ious expe ience in using DMH p og ams, bu he majo i y epo ed medium (4/11, 36%) o s ong (5/11, 45%) skills in using digi al echnology. The subsample o MHPs was composed o 15% (2/13) psychia is s and 85% (11/13) clinical psychologis s. Mos p o essionals we e emale (11/13, 85%), and hei median age was 35 yea s (IQR 11; minimum 25, maximum 56). The median o MHPs’ p o essional expe ience was 11 yea s (IQR 11). Mo eo e , 92% (12/13) o p o essionals we e ac i e, and 30% (4/13) wo ked in psycho-oncology se ices. App oxima ely JMIR Cance 2022 | ol. 8 | iss. 1 | e33550 | p. 6h ps://cance .jmi .o g/2022/1/e33550 (page numbe no o ci a ion pu poses) Mendes-San os e alJMIR CANCER XSL • FO Rende X hal o ou sample (7/13, 54%) held a CBT o ien a ion. Conside ing pa icipan s’p o iciency in using digi al echnology, mos p o essionals (11/13, 85%) classi ied hei skills as medium. App oxima ely hal o p o essionals (7/13, 54%) epo ed p e ious expe ience in using DMH p og ams. Table 1. Pa icipan s’cha ac e is ics (N=24). BCSb(n=11)MHPa(n=13)Va iables Sex, n (%) 11 (100)11 (85)Female 0 (0)2 (15)Male Age (yea s), n (%) 0 (0)3 (23)23-30 4 (36)7 (54)31-40 4 (36)2 (15)41-50 2 (18)1 (8)51-60 1 (9)0 (0)61-70 Highes academic deg ee, n (%) 2 (18)0 (0)Basic deg ee (≤9 school yea s) 2 (18)0 (0)Seconda y deg ee (12 school yea s) 7 (64)13 (100)Uni e si y deg ee Sel - epo ed p o iciency in using digi al echnology, n (%) 2 (18)1 (8)Poo 4 (36)11 (85)Medium 5 (45)1 (8)S ong Sel - epo ed use o digi al men al heal h, n (%) 11 (100)6 (46)None 0 (0)4 (31)Occasional 0 (0)3 (23)Regula aMHP: men al heal h p o essional. bBCS: b eas cance su i o . Use ulness iNNOVBC’s pe cei ed use ulness was assessed du ing he in e iews conduc ed be o e and a e he usabili y es s and by su eying ield ial pa icipan s on he use ulness and adequacy o he p og am’s modules. Du ing he ield ials, he con en o he modules li ing wi h b eas cance and beyond (4/11, 36%), anxie y (1/11, 9%), elaxa ion (1/11, 9%), sleep (1/11, 9%), and a igue (1/11, 9%) we e app aised, wi h all being a ed wi h 5 (ou o 5) s a s by BCSs e alua ing i . O e all, pa icipan s ound he p og am’s app oach, con en , and ea u es as highly ele an and use ul. BCSs classi ied he con en o he modules as e y use ul (3/8, 36%) o ex emely use ul (5/8, 63%) and e y adequa e (3/8, 36%) o ex emely adequa e (4/8, 50%) in add essing hei di icul ies and needs. Only 13% (1/8) o he pa icipan s epo ed ha he elaxa ion module was nei he adequa e no inadequa e o he needs. All su i o s (8/8, 100%) epo ed ha hey would ecommend he modules o a iend o amily membe going h ough he same condi ion. Conside ing he ole iNNOVBC could play in BCSs suppo i e ca e, bo h su i o s and p o essionals conside ed iNNOVBC could ha e a signi ican impac in suppo ing BCSs h oughou he cance con inuum: The e we e a lo o doub s, e e s, discom o s, disquie udes... he e s ill a e...and i I had his ype o esou ce, I could ha e used i ins ead o googling o looking in o pa ien g oups, o some kind o answe ...Because you do eel he need o go o o ums and ask, does anyone eel like his? Wha ha e you done? And i he e we e a pla o m like his, he ype o suppo p o ided would be di e en , mo e c edible and app op ia e. [BCS11] Simila o BCS11, mos pa icipan s alued he possibili y o accessing “ us wo hy” (BCS6) sel -ca e in o ma ion p o ided “any ime, anywhe e” (BCS7) ia iNNOVBC. The in e iewed BCSs had sea ched on he web o in o ma ion on ea men s’ ad e se e en s, p ac ical s a egies, and emo ional challenges hey we e aced wi h, bu hei sea ches we e leng hy and equi ed hem o assess he quali y o in o ma ion hey we e JMIR Cance 2022 | ol. 8 | iss. 1 | e33550 | p. 7h ps://cance .jmi .o g/2022/1/e33550 (page numbe no o ci a ion pu poses) Mendes-San os e alJMIR CANCER XSL • FO Rende X p esen ed wi h. Bo h BCSs and MHPs conside ed ha ha ing “easy access o e idence-based eady o use psycho-educa ional con en ” (MHP10) could help su i o s be e manage hei condi ion and p oblems. Acco ding o he pa icipan s, he su i o ship ajec o y is cha ac e ized by many biopsychosocial challenges ha deeply impac su i o s’ well-being. Se e al pa icipan s desc ibed he pe asi e and long-las ing impac ha ea men ’s ad e se e en s o sequelae had on hei physical and men al heal h, unde lining he impo ance o ecei ing accu a e and comp ehensi e in o ma ion abou i . E ec s such as alopecia, onycholysis, pain, menopausal symp oms, a igue, ca dio oxici y, lymphedema, os eopo osis, in e ili y, and memo y loss we e o en discussed by in e iewees as key in o ma ion poin s o add ess in a nuanced and dynamic manne . Du ing he cou se o ea men , a ious su i o s ecei ed lye s and bookle s abou ea men s’ ad e se e ec s, bu mos complained abou hei unappealing design and low in elligibili y and ocus on he ac i e ea men s age, he e o e ailing o p o ide a con inuous pe spec i e on i s managemen a e ea men comple ion. The ac ha iNNOVBC app oached many o hose hemes “in a ch onological way” (BCS1) was app ecia ed by a ious BCSs because i enabled hem o p epa e and cope wi h i in he long e m. The impac o cance and i s ea men s on su i o s’emo ional heal h was ano he ma e o conce n. Bo h MHPs and BCSs unde lined he impo ance o p o iding psychological suppo o BCSs h oughou he cance con inuum, pa icula ly du ing he ansi ion om ac i e ea men o ollow-up ca e: Ge ing psychological suppo is e y impo an a all s ages...a he diagnosis, du ing ea men and a e ea men ...People a e no awa e o his, hey end o say “Ah, ha ’s o e now!” and expec us o e u n o whom we used o be...Bu ha ’s no possible...you s ill need suppo . This eels almos like...a pos - auma ic si ua ion...and by saying ha i ’s almos like hey’ e aking away you legi imacy o eel he pain, so i can eel e y isola ing o c oss ha pa h. [BCS2] I ’s an ab up shi om being ex emely ca ed o , om ha ing ha uncondi ional suppo du ing chemo o s opped being ca ed o ...As soon as you hai s a s o g ow, e e yone assumes ha e e y hing is ine. Bu i ’s no . I will ne e be able o say again ha I’m ine. I’m no healed, I’m ull o ea s, anxie y, and so ow. So...i was ex emely ha d o me o deal wi h ha because I el abandoned...people had pulled he ug ou om unde me. [BCS7] Simila o BCS2 and BCS7, a ious pa icipan s discussed he expe ience o eeling in dis ess and unsuppo ed a e inishing he p ima y ea men . P oblems such as “dealing wi h low mood” (BCS11), “ eeling anxious all he ime” (BCS2), “ ea ing ha cance had e u ned” (BCS8), o ea o “dying” (BCS9) we e common, o en impac ing BCSs’ sleep and in e pe sonal ela ionships. Di icul ies in adap ing o a “sca ed body image” (BCS5) we e also p e alen in in e iewees’ na a i es and a ious pa icipan s epo ed on he p o ound impac i had on hei sel -es eem, sexuali y, and in ima e ela ionships: Losing my b eas shook my sel -es eem, i shook e e y hing...i ’s ha d o li e wi hou i , I’m a woman. I...I’m incapable o being naked in on o my husband. I eel emba assed...I’m no able o hug him anymo e. I’m a aid he eels ha i ’s no my b eas , ha i isn’ eal. I sleep...wi hou he p os hesis, bu I always y o sleep wi h my back o him and when I ealize I’m acing him, I u n o e igh away...I’m a aid ha i he sees me, he migh lose his in e es in me, ha he s ops desi ing me. ...We s ill ha e sex bu i ’s no he same. I’m always a aid ha he ouches whe e he’s no supposed o...I do no lean agains him...I a oid his ouch. I ’s di icul and...I know ha he e a e women ha deal wi h his well, bu I...I do no . [BCS9] Simila o BCS9, a ious pa icipan s alked abou no being able o adap o hei changed sel , eeling like a ake e sion o hemsel es, incapable o es o ing los in imacies, and isola ed by he “ abu cance had become” (BCS2) in hei inne ci cles. Coping wi h such p oblems was highly demanding, and many s uggled o discuss such opics wi h iends, amily, and p o essionals owing o hei sensi i e na u e. Thus, many in e iewees app ecia ed he “asse i eness o he hemes” (BCS6) explo ed a iNNOVBC and he possibili y o ecei ing p o essional suppo a a dis ance o wi hou ace- o- ace con ac : I ’s impo an o ha e suppo bu i ’s uncom o able o alk abou hese issues ace- o- ace...Maybe h ough his pla o m, i could be easie ...I belie e I could eel mo e com o able o ask some ques ions i I knew his was anonymous, i I didn’ ha e o iden i y me...I belie e i would be much easie o app oach in ima e opics ia cha o e-mail han in-pe son. [BCS3] Pa icipan s such as BCS3 app ecia ed he ac ha iNNOVBC allowed di ec communica ion be ween MHPs and BCSs. Bo h p o essionals and su i o s conside ed ha ing cha , email, and ideocon e ence communica ion al e na i es o be help ul. By o e ing synch onous and asynch onous communica ion channels associa ed wi h di e en deg ees o exposu e, pa icipan s conside ed ha iNNOVBC “could p omo e su i o s’ sel -disclosu e” (MHP6) and acili a e he “ imely discussion” (MHP4) o sensi i e opics, ul ima ely, “bene i ing he he apeu ic p ocess” (MHP12). They also saw ad an ages in he possibili y o au oma ically sending psychoeduca ional con en and scheduling and no i ying BCSs abou asks and ques ionnai es o be comple ed along he implemen a ion o he p og am: The unc ionali ies a e well hough and he ac ha e e y hing is in eg a ed is awesome... his combines a modula ea men app oach wi h ideocon e ence and cha ...i allows you o ake no es...and he ins umen s a e embedded...Tha ’s awesome and exac ly wha I need in my p ac ice! [MHP5] The ac ha iNNOVBC combines e idence-based con en wi h communica ion, moni o ing, and documen a ion ea u es was JMIR Cance 2022 | ol. 8 | iss. 1 | e33550 | p. 8h ps://cance .jmi .o g/2022/1/e33550 (page numbe no o ci a ion pu poses) Mendes-San os e alJMIR CANCER XSL • FO Rende X p aised by a ious p o essionals. The in e iewed MHPs conside ed ha i could educe he ime and e o hey need o in es in inding, p epa ing, and assessing ma e ials, enabling hem o wo k mo e e icien ly. iNNOVBC was also conside ed use ul o p omo e “con inui y o he ela ionship es ablished be ween he he apis and he clien ” (MHP7) beyond appoin men s. Mos impo an ly, by doing so, iNNOVBC could con igu e a poin -o -need se ice ha could suppo BCSs along he su i o ship ajec o y. Ne e heless, i is impo an o say ha iNNOVBC’s use ulness could be comp omised by i s “lack o in ui i eness” (MHP9). Usabili y Bo h he quan i a i e and quali a i e da a collec ed du ing he usabili y es s and in e iews iden i ied design and unc ionali y issues ha could be imp o ed o enable mo e e ec i e and e icien use o iNNOVBC and inc ease use s’sa is ac ion wi h he p og am. In gene al, pa icipan s’e ec i eness, as measu ed by comple ion a es, was high in bo h g oups ( ange 69.2-100; Tables 2 and 3), bu he Sys em Usabili y Scale median sco e was 65 (IQR 35) o BCSs and 47.5 (IQR 25) o MHPs, which may be conside ed below a e age in e ms o usabili y. These esul s a e aligned wi h he usabili y issues iden i ied du ing he usabili y es s. Table 2. MHPalabo a o y-based usabili y es esul s. Assis ances, mean (SD) E o , mean (SD)Task pe o mance, %Task g oups and asks A: Log-in 0.1 (0.3)0.2 (0.4)100 1. Log in o he iNNOVBCb B: No i ica ions 0.4 (0.6)0.8 (1.2)84.62. Check no i ica ions 0.7 (0.8)2.3 (2.6)1003. Comply wi h he no i ica ions’ins uc ions by accessing he pa ien ’s ile C: T ea men p esc ip ion 0.7 (1.1)3.2 (5.1)1004. Click on he pa ien ’s link o sea ch o he pa ien 0.2 (0.4)1.1 (1.2)1005. Check he modules p esc ibed o he pa ien 0.1 (0.3)0.6 (1.1)1006. Assign he sleep module o he pa ien 0.3 (0.8)0.4 (0.7)69.27. Send a no i ica ion o he pa ien 0.2 (0.4)0.1 (0.3)1008. Sa e he p e ious p ocedu e 1 (1.3)3.2 (6.6)1009. Check he a ailable clinical ials 0.4 (1.1)0.6 (1.3)10010. P esc ibe iNNOVBC o he pa ien and schedule he onse o he ea men 0.1 (0.3)0 (0)10011. Sa e he p e ious p ocedu e D: T ea men p og ess assessmen 1.1 (1.2)3.8 (5.1)10012. Send eedback o he pa ien abou he homewo k assignmen 0.4 (0.7)0.7 (1.4)10013. Access he pa ien ’s ile 1.4 (1.4)3.8 (3.0)10014. Click on ques ionnai es 0.4 (0.8)1.6 (3.4)10015. Check he ques ionnai es a ailable o p esc ibe 0.6 (0.8)1.5 (2.4)10016. Assign he weekly ques ionnai e o he pa ien 0 (0)0 (0)10017. Sa e he p e ious p ocedu e E: Con e sa ions 0.5 (0.6)1.6 (2.1)10018. W i e an email o he pa ien 0 (0)0 (0)10019. Send he email 0 (0)1.5 (2.8)10020. S a a cha con e sa ion wi h he pa ien 0.1 (0.4)0.1 (0.3)10021. S a a ideocon e ence appoin men wi h he pa ien 0.8 (1.2)4.4 (5.2)10022. Upda e he pa ien 's clinical dia y 0.1 (0.3)0.6 (0.8)10023. Schedule he nex appoin men and se an ala m aMHP: men al heal h p o essional. biNNOVBC: iNNOV B eas Cance . JMIR Cance 2022 | ol. 8 | iss. 1 | e33550 | p. 9h ps://cance .jmi .o g/2022/1/e33550 (page numbe no o ci a ion pu poses) Mendes-San os e alJMIR CANCER XSL • FO Rende X [DOCX File , 24 KB-Mul imedia Appendix 2] Mul imedia Appendix 3 B eas cance su i o s’and men al heal h p o essionals’iNNOV B eas Cance usabili y es p o ocol and obse a ion ables. [DOCX File , 35 KB-Mul imedia Appendix 3] Mul imedia Appendix 4 B eas cance su i o s’and men al heal h p o essionals’deb ie ing in e iew sc ip s. 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New Yo k: Associa ion o Compu ing Machine y; 1993 P esen ed a : CHI '93; Ap il 24-29, 1993; New Yo k p. 206-213 URL: h ps://doi.o g/10.1145/169059.169166 [doi: 10.1145/169059.169166] Abb e ia ions ACT: accep ance and commi men he apy BCS: b eas cance su i o CBT: cogni i e beha io al he apy DMH: digi al men al heal h HRQoL: heal h- ela ed quali y o li e iNNOVBC: iNNOV B eas Cance MHP: men al heal h p o essional Edi ed by A Ma agani; submi ed 12.09.21; pee - e iewed by M P i cha d, T Cai; commen s o au ho 05.01.22; e ised e sion ecei ed 07.01.22; accep ed 12.01.22; published 15.02.22 Please ci e as: Mendes-San os C, Nunes F, Weide pass E, San ana R, Ande sson G De elopmen and E alua ion o he Use ulness, Usabili y, and Feasibili y o iNNOV B eas Cance : Mixed Me hods S udy JMIR Cance 2022;8(1):e33550 URL: h ps://cance .jmi .o g/2022/1/e33550 doi: 10.2196/33550 PMID: ©C is ina Mendes-San os, F ancisco Nunes, Elisabe e Weide pass, Rui San ana, Ge ha d Ande sson. O iginally published in JMIR Cance (h ps://cance .jmi .o g), 15.02.2022. This is an open-access a icle dis ibu ed unde he e ms o he C ea i e Commons A ibu ion License (h ps://c ea i ecommons.o g/licenses/by/4.0/), which pe mi s un es ic ed use, dis ibu ion, and ep oduc ion in any medium, p o ided he o iginal wo k, i s published in JMIR Cance , is p ope ly ci ed. The comple e bibliog aphic in o ma ion, a link o he o iginal publica ion on h ps://cance .jmi .o g/, as well as his copy igh and license in o ma ion mus be included. JMIR Cance 2022 | ol. 8 | iss. 1 | e33550 | p. 20h ps://cance .jmi .o g/2022/1/e33550 (page numbe no o ci a ion pu poses) Mendes-San os e alJMIR CANCER XSL • FO Rende X