Canadian Cancer

today, we have the pleasure of dr. sylvielambert who will be presenting to us “you need something like this to give you guidelineson what to do” development and initial evaluation of a self-directed coping skills trainingresource for patients with cancer and their partners. so, sylvie, i’ll turn it overto you. you give a presentation and we’ll give time for questions of all the participantstoday afterwards great, well thank you catherine. good afternooneverybody, i’m really happy to be here today, have the opportunity to present on the developmentand initial evaluation of a self-directed coping skills training resource for patientswith cancer and their partners that we call “coping together”. i’m originally frommontreal from mcgill university; i graduated

from the phd program, the school of nursingin phd program in 2008. shortly thereafter, i would marry an aussieand getting a 2 year post-doc position with the university of newcastle in australia.then i join the university of new south wales. i’ve been asked for help in medical researchcouncil fellow and that took an additional two and a half years. so i lived in australiafor almost 5 years and most of the work that i’ll be presenting…well all of the workthat i’ll be presenting today was conducted during back in time. i moved back to canada,i am back in montreal…actually back in mcgill. i joined the school of nursing faculty a yearand half ago the projects that are part of my psychosocialoncology program of work mainly focused on

better understanding of substantial impactof cancer on patients and their caregivers and i’m particularly interested in interdependenciesamong patients and caregivers outcomes. a few of my projects also focus on developingand evaluating self-care and self-management interventions for patients and their caregiversincluding evaluating different health services delivery model that has more potential tobe translated in clinical practice and also evaluating the methods that we use in psychosocialresearch particularly using either response theory to evaluate the measures that we commonlyuse. so for the n ext 35 minutes, i’ll be presenting some of the key findings from australiafirst, longitudinal partners and caregivers wellbeing study. that was conducted mainlyin the first few years that i was there as

part of my post-doc and the findings fromthis study, particularly in terms of anxiety and depression, really informs or really guidedus in developing our ‘coping together intervention’. so then, i’ll focus on how we went aboutdeveloping and some initial evaluations. this program works because the together programwork is still ongoing in australia. so my program work and most of my projectthat i conduct are focused very much on partners and caregivers or have a dyadic focus. andalthough research has traditionally focused on negative impacts of cancer on patients,during the past decade has seen a in the attention, even the ripple effects of diagnosis and treatmenton patients’ primary support person and that is their partners and their caregiverscancer is actually the second most common

condition in canada requiring help from theircaregivers and the reliance on them is only expected to continue to grow particularlyas the course of cancer is changing from acute to chronic disease and the is shifting fromthe hospital to the home. and although support reduces the demand on the healthcare system,that is well documented, and the support positively impacts on how well patients adjust to theillness and that’s come at a particularly high cost to caregiver’s own health andfunctioning. a number of studies have shown that partners and caregivers experience manyhealth problems as a consequence of their roles. most problems include fatigue, pain,and loss of physical strength. partners and caregivers experience changes in expectationsand family responsibilities, they often feel

stretched in many directions and struggleto remain in flow of their own main priorities. it is not uncommon that, partners and caregiverseach reduce the number of hours that they work which impact then, on their financialstatus. and depending on the patients’ diagnosis, partners and caregivers also face a numberof complex illness management tasks and a point here is that, they typically face thesewith little to no formal training. a number of studies have also found out that partnersand caregivers experience many emotional challenges that are analogous to those reported by patients– including shock, anxiety and depression. but these are actually experienced more intenselyin partners and caregivers the responsibilities that the cancer caregiverstake on has in turn prompted much interest

in the kind of support that they need. thisis also referred to as ‘supportive care needs’ and our chain has just recently completeda systematic review, examining their unmet supportive care needs. where do partners andcaregivers need more support? this review found that actually up to 68% of caregiversreport needing more support. and of note, these rates actually exceed those reportedby other systematic review examining that supportive care needs on patients. our reviewactually identified 6 domains of unmet needs. the first one - comprehensive cancer care,where, prominent needs within this domain included awareness and available resourcesand having a sympathetic relationship with healthcare professionals. the second domain- emotional and psychological prominent unmet

needs were needing emotional support and guidanceon dealing with not only one’s own emotional distress but also patients’ emotional distress.financial support and knowing how to maintain a sense of control over the situation withtwo prominent needs in the third domain of partner and caregiver impact in the activities.and most prominent unmet needs were in the vicinity of the three domains but we alsoidentified an important unmet need within the relationship, within the relationshipdomain, information, and spirituality. and the most prevalent ones were health communicationabout illness, information about what to expect and feel there is some hope in the future.so, although we know quite a bit about what are some of the challenges that partners andcaregivers face and how they adjust to the

cancer diagnosis and the roles and responsibilities.there are a number of gaps in the literature that remain and warrant additional studies.particularly that more studies are cross-sectional, have a small sample – so we’re talkingabout less than 150 often, and focus on particular subgroups of partners and caregivers – particularlythose of women with breast cancer and men with prostate cancer. and it is because ofthese limitations, that are there embarked upon the first longitudinal study of partnersand caregivers of patient’s diagnosis. one of the most common cancers in australia. andthe main aim of this study was to describe changes in anxiety, depression, quality oflife and unmet needs and identify variables associated with these outcomesour participants were given a survey at 6

months, 1 year, 2 years, 3.5 years, and 5years. this survey was quite comprehensive and included a number of well known surveysto measure the desirable variable and moving into the intervention, i’ll focus on theanxiety and depression because it’s very much that initial…those variables that theninforms the focus of our ‘coping together intervention’ and i’ll focus on the firstthree data collection time points. the demographics of our participants in thisstudy are comparable to those reported in other studies. at baseline, more than twothirds of the participants were females, the mean age was 56.6, and those participantswere actually the partner of the patients and living with the patientsthe three most common diagnosis of the cancer

patients were prostate, melanoma or breastcancer. so, in terms of the findings, what did we learn for anxiety? well we learnedthat at baseline, the prevalence of anxiety, so the blue bar and this is defined at a scoreof 8 or more in the hospital anxiety depression scale that was the scale that we used. theprevalence of anxiety among partners and caregivers, as you can see, it exceeded population norm– measured by the hads. although there was a significant decrease in anxiety over time,at each time point, the prevalence of anxiety reported by caregivers significantly exceededthe rate reported by the patients themselves. so although, we expected that with time, weprobably would see a decrease in anxiety, we definitely expect that, at each time pointthere would be anxiety among partners and

caregivers significantly exceed what was reportedby patients for depression, both at 6 and 12 months, theprevalence of depression among partners and caregivers also exceeded the population norm.and similarly, there was a significant decrease in depression over time. but only at 12 months,the prevalence of depression reported by partners and caregivers significantly exceeded therate reported by the patients. so, although the data that i presented onthe previous two slides indicate that, as a group, partners and caregivers – anxietyand depression. however, we can hypothesize that in some subgroups, it’s possible thattheir anxiety or depression does not get resolved. or others might experience an increase inanxiety over time. you don’t get that from

a lot of the summary data but our presentlongitudinal study and definitely what i’ve presented in the past 2 slides. and what wewanted to do is definitely be able to tease out these different subgroups because theseare probably some of the subgroups that most are concerned about. and to be able to dothis, we conducted what’s called a trajectory analysisand i’ll be presenting the results of this trajectory analysis now. so these are ourfindings for anxiety. so, just as a reminder, we use the hospital anxiety and depressionscale where scores of 8 – 10 are categorized as borderline anxiety and scores of 11 ormore are categorized as clinical anxiety. so what we found - again we have the 3 collectiondata time points – is that two groups of

partners and caregivers did not experienceanxiety at a level that was of concern. so, where you see the group 1 and the group 2.so that data represents almost 50% of the sample. so, where we’re concerned is, wedo have a group and it still represents a third of the sample and they experience whatwe labeled as chronic levels of borderline anxiety. and even more concerning, we have14% of caregivers experiencing chronic levels of clinical anxiety – and it’s chronicbecause as you’ll see for the third trajectory and the fourth trajectory, these are almostflat lines. although, the fourth trajectory, there is a steady decline, it’ll be somethingthat will be further analyzed data to see whether decline becomes more pronounced withtime but despite that decline, they still

remain above that cut-off point for clinicalanxiety and i do want to emphasize - this at the end of 2 years.for depression, similarly, we have two groups recording levels of depression below the borderlinecut-off score but they represent a much larger proportion of the sample. we do have abouta quarter of the sample reported close to the borderline cut-off point across time.and 4% of participants - recognize that it is a smaller subgroup - reported chronic depression.so these analyses led us to conclude that distressed partners and caregivers do notrecover easily. our next set of analysis focus on ‘what are those risk factors of beingin the trajectories and being in those trajectories of chronic levels of clinical anxiety or depressionwe looked at a number of demographic variables;

we also looked at psychosocial variables.none of the demographic variables predicted membership to chronic levels of anxiety ordepression using logistic regressions. but however, in terms of psychosocial variables,we noted that, higher avoidant coping, low social support, high caregiver burden andhigh unmet supportive care needs, predictive memberships to chronic anxiety and/or depression.and so, with those early analysis or our longitudinal partners and caregivers studies, we were slowlythinking about ‘what are some of the potential interventions that we should be putting inplace?’ and given some of our analysis, we definitely knew that we wanted to implementan intervention early on to really try to help with partners’ and caregivers’ recoveryin terms of anxiety so as much as possible,

within the first 6 months, post-diagnosis.but an intervention that could be sustained over time.we knew the risk factors that we would want to target, recognizing that these are riskfactors that have also been identified to impact on patients’ adjustments and outcomes.and also back in time, so talking about 2009, there was some literature emerging documentsin that patients and partners reacted to cancer diagnosis as an interdependent emotional system.their anxiety and depression are moderately positively correlated. so, although we’reconducting a longitudinal study, the intent was to develop caregiver intervention. wereally then shifted our minds to think about a dyadic coping skills training interventionand that would then focus on our intervention

workat that time, when we the literature to see “do we need to develop our own or do weneed to think about adapting an intervention?” we and we found that there were about 12 studiesthat had been already published. these studies were very encouraging in terms of the impactof these dyadic interventions for both patients and their caregivers in terms of increasingquality of life and self-efficacy, increasing adaptive coping, relationship functioningand social adjustment, positive illness or caregiving appraisal as well as decreasingphysical and psychological distress. so that was encouraging and further pursued the ideaof focusing on a dyadic intervention but we also realize that these interventions havea number of limitations with the ultimate

goal of being highly translated clinical practice.the fact that a lot of these interventions more delivered by highly trained healthcareprofessionals, really limited their long-term sustainability. all of the interventions thatwe reviewed, to our knowledge, had not been reviewed in to the practice mainly becauseof their high cost and limited availability of qualified health professionals. a reviewthat we conducted also revealed that the uptake of couple-based intervention are often loweven the patients’ and their partners’ given by the format that are being used. andoften because they’re not willing to travel for the intervention or the intervention isoffered at a time that caregivers are not available particularly when this does requiretaking time off, it’s just not feasible

for them to make it to the intervention. sothen we thought well we really need to think about an intervention, a couple-based dyadicintervention that is cost-effective, sustainable and efficacious. so we’re trying to worka number of alternative 19:29 format for our interventions. there was definitely some discussionsabout a group-based intervention, however, our meta-analysis found, among patients, amongcaregivers, that individual treatment approaches had significantly larger effects than groupapproaches for distress so we were wondering whether this was an efficacious format foran intervention but more importantly we thought that this did not resolve some of the caregiverbarriers previously identified in terms of accessing our intervention. telephone basedintervention was also something that was proposed

and whether we should go about that way, it’sa format that is extremely popular in australia given that a lot of the population are ruraland remote area so people are used to that intervention format but still mixed efficacystudies, mixed evidence in terms of their efficacy really put into questions formatand also we weren’t convinced that some of the data that i mentioned previously interms of still having to be on the phone at a specific time would really resolve someof the access or barriers – accessibility barriers.we then got very interested in self-directed or self-administered format. particularlywith some of the work of jacobson and uh… paul jacobson and in the u.s among patientsand found that you know, this wasn’t acceptable

format to patients and increased accessibilityand sustainability as well. there were no self-directed couple-based intervention atthat point in time so we felt that what the caregivers are indicating in the literaturein terms of access barriers we felt that this was probably the most promising delivery formatfor our intervention. so therefore, we developed a self-directedcoping skills training intervention for patients with cancer and their partnersthe core components of coping together is a series of 6 booklets which translates themost up-to-date evidence on adaptive coping strategies and presents these to couples as“suggestions” to address specific challenges across 6 topics. the topics are: 1) gettingon top of symptoms 2) dealing with stress

and worries 3) supporting each other 4) gettingwhat you need from your healthcare team 5) making your treatment decisions, and 6) gettingthe support you need. now at this point in time you might be wondering “do we reallyneed these series of booklets? is this necessary?” we definitely, most of these, at that pointin time in australia, most of the resources that were available very much address ‘whatis cancer?’, ‘what is treatment?’ as do a lot of the resources do here in canada.so there’s definitely a lack in terms of really presenting to the couples some of thestrategies that were evidence based that we knew to make a difference in their daily lives.so the focus was really on translating that evidence base to easily accessible to patientand partners.

so the booklet, every booklet starts witha flow chart as you see on this slide that’s up right now and this is getting what youneed from your healthcare team booklet and on the left hand side you see that, withinthis booklet, we address 6 different challenges related to this topic and the second columnright away on the right hand side, matching strategy and every booklet starts the sameway. challenges are quickly identified as well as our suggestions of how to addresseach of the challenges in addition to the booklets, the coping togetherintervention includes a dvd which features clinicians who explains the aspects of thebooklets and also includes role plays with couples. not giving a testimonial but reallydemonstrating specific coping skills and often

you give a scenario of how using that copingskills went well or didn’t go well and what are some strategies to overcome barriers implementingsome of these coping skills. there’s also a learning to relax cd and this was made availablethrough the canadian cancer council which is equivalent to canadian cancer society.there’s a very good booklet with a very good cd which provide step-by-step for keyrelaxation strategies described in the dealing with stress and worry booklet. we also havea website that really acts like a repository for the booklets – the pdfs of the booklets– and videos for the dvds. it does not take advantage as much as it could of the onlineplatform. that’s because in our feasibility testing, participants told us that they didnot want a web based intervention. so the

website is there and will be further developedas we move on along in terms of testing online platform now you know, it’s 5 years laterwhen we started developing the intervention in 2009. so as we move forward we are goingto use it either platform to develop and take advantage of the online platform but it’snot there at this point so what you saw on the previous slide is reallythe final version of coping together. it did not start out that way. coping together isa program of work that has 3 phases. we began the development of the program in 2009. wethen embarked pilot studies with men with prostate cancer and their wives. and recentlywe began the recruitment for a large randomized-controlled trial. so for the purpose of today, the secondpart of my presentation, i will be focusing

on phases 1 and 2. i do hope that within ayear or so i can come back and present some of the data for the randomized-controlledtrial but the recruitment is very much ongoing for that phase.so in terms of phase 1, as soon as we began the development of the booklet, we presentedthese to couples to obtain their feedbacks on the appropriateness and to gain the sensethat they were willing to use the booklets to learn about coping strategies and how doesthat works within a dyadic context. so this initial qualitative feasibility study included27 patients and 12 of their partners. across the patients and partners that interviewedfor this feasibility study, we did get quite a bit of variability in terms of time of diagnosis.it’s really ranging from a few weeks…few

months sorry, to well into long term survivorship.variability in terms of cancer type is also noteworthy to a certain extent.our study structured interviews identified three strengths of our intervention design.the first strength was really that it was a self-directed format that was clear notonly for the partners but for the patients. after both patients and partners, that wasin preference to for example, attending a support group. so we were quite encouragedthat, not only for the primary population which is the partners, we were reaching asubgroup that normally would not have accessed additional service but this is also true forthe patients. p: the second strength of the booklet wasthat we were targeting both patients and their

partners. and for many of the partners, theyhad not received any of the other resources that was statistically meant for them. theyoften read what was given to the patients but partners and caregivers are often secondaryfocus event of many of these resources and it was quite comforting for the patients toknow that their partner now is receiving something that was meant for them.the third strength of our intervention identified through the initial qualitative feasibilitytesting was its focus on practical coping strategies and we hypothesized that this wasthe feature that was setting us apart from what was existing now and patients and partnersconfirmed that for us. so they have received from cancer council ‘what is cancer?’‘what is treatment?’ and healthcare professionals

had given them information but also they’reoften told “you need to relax, you need to communicate with your partner and you needto this…and you need to do that” but nobody were telling them how to do these activitiesor any strategies. and that’s where coping together picks up for many of the patientsand the partners. the strategy we proposed were felt to be plainly spelled out. theywere doableand that sufficient details have been provided to understand the strategies.and on this slide… i’m just giving you some examples in termsof the some of the strategies that were popular among patients and partners. so for thoseparticipants that were previously unaware of the strategies definitely our interventionseemed to actually develop their repertoire

of coping skills. whereas for those alreadyusing the proposed strategies or those that had used them in another context, coping togetherreally confirmed that they were on the right track that these weren’t neither strategiesthat even if they were using other context, can be used in the current context – indifferent cancer context. so they have the skills but mainly, the participants were actuallynot sure whether it also applied to this current context – to their current context. so theprimary purpose of coping together, based on the qualitative study, seemed to be feasible.it seemed to be feasible that we can expect couples to learn through our resource someof the coping skills that they need to address their challenges. so we were quite encouragedby this initial testing but there were through

these interviews, there were also a numberof secondary benefits that were identified by using this resource.this included having a sense of the…these resource provided a sense of normancy or hopethat something can be done to pull through. so just knowing that someone else went throughthe same situation or is going through the same situation and recognizing that theseissues – that’s not you that’s experiencing these issues was comforting for many of ourparticipants. and coping together also have the secondary benefits of connecting patientsand partners to services so we always had a resource page and it was interesting tofind that patients and partners often did not know the roles of different healthcareprofessionals or did not know some of the

community resources that were available tothem but coping together really really emphasized who they can go and talk about these issuesand also what are some of the potential community resources that they can call upon. and thelast secondary benefit is that in many cases, the booklet complemented information participantshad received from their health professionals but it provided more details of how thesecoping strategies can be implemented. often healthcare professionals had mentioned thesecoping strategies but very much in passing and had not really provided the informationthat needed to be able to implement these. so these findings are from uh…really encouragedfor us in terms of the benefits but i should note that this comes from about 50% of oursample. it should be noted that the other

50% of our sample did not really use the interventionat the time that we introduced them. and so we actually spent a lot of time talkingto them “what were some of the barriers in using this intervention?” and i thinkthat’s main…one of the disadvantage of self-directed format in terms of if it doesrequire a lot of motivation from the patients and their partners to open the envelope, readthrough the booklet, identify when they have a challenge that is relevant for the copingskills that we are trying to communicate, then learn the coping skills, implement thecoping skills. so it’s a lot of steps and in some situations, the way we tried to facilitatethat process was not successful. and so a lot of the barriers were identified duringthese interviews but also a lot of strategy.

and we spent a lot of time then modifyingintervention, integrating strategies that patients and partners had mentioned. and ijust want to review a few of these with you because they did seem to make a differencein the end. so although we were going 100% self-directed format, our participants reallyfelt that if they had been provided with initial workshop or an orientation session whetherit was face-to-face or over the phone that would’ve made the difference. people receiveda lot of mails, a lot of packages. they were receiving packages from cancer council atthat point in time - depending on their diagnosis they might’ve been receiving something fromthe australian breast cancer foundation. and so they were receiving a lot of informationand the benefits of coping together was not

apparent by the package. so receiving a phonecall that would really emphasize those benefits would’ve really helped with use. a secondstrategy that was mentioned was to tailor the information to their characteristics.now, this is challenging in a manual based format when this was raised with us, we didtalk about whether an online format would be more relevant but in a feasibility testing,it was almost 100% from patients and partners that an online format was not favored. sohaving to tailor the information is challenging for printing resource. so what we did wasthat, we actually developed those flow charts. so the flow charts really came out of thefeasibility testing. that we make it really easy to self-tailored. a second…a thirdstrategy was to present the information in

a concise way. be very very point formed.so initially in each section of the booklet we might have had 7 – 10 pages, we thencalmed it down right away to 3 – 5 pages and so as soon as partners and caregiversgo on the first page of the section, they would have access right away to the informationthat they need. they also suggested that we should have a dvd which we did produce. aswell as page turner the booklets were felt to be too clinical, unattractive. people feltthat they were in a therapy session reading the booklet. so we suggested that we havea page turner which included for them which meant for them having testimonial and cartoonswith huge captions. and there’s actually evidence that has shown that including cartoonswith captions in print-based materials actually

enhances comprehension and retention. so wedid exactly that and our cartoons actually illustrate the coping skills that were talkingabout in a given section and so as we integrated all of those strategies, we did take quitea bit of time especially to produce the dvd and once we were ready, we finally embarkedupon our pilot testing our pilot testing focused on examining theacceptability of evaluating of the message to evaluate coping together in a larger trialthat we were aiming for and collect preliminary efficacy and cost data. in this study convenientsample of 42 men diagnosed with early stage prostate cancer and their partners were recruitedacross 6 sites in australia and randomized to what’s called a ‘minimal ethical carecondition’ which is referred to as mec or

to coping together. the patient inclusioncriteria were: 1) diagnosed in the past 4 months 2) receiving or planning to receivetreatment and this included for our pilot 3) active surveillance 4) having no previouscancer diagnosis and having a partner willing to participate. for us a partner was a styleof boyfriend/girlfriend or be facto. in addition, to be eligible for this study, the patientor the partner have to score 4 or more under the stress thermometer at the time of recruitment.all couples completed a baseline survey and they were asked to complete a survey 2 monthslater. they were also asked to complete a cost diary and participate in a series ofphone interviews so this is the flow chart to illustrate thestudy method. coping together couples received

the intervention materials within 2 weeksof returning their baseline survey and for our pilot, we had 4 of the 6 coping togetherbooklets available so it focused on 1) getting on top of the symptoms 2) getting what youneed from the healthcare team 3) supporting each other and 4) dealing with stress andworry. couples did receive the relaxation cds, that was the first time they got thecd and a dvd which featured only one of the booklet which was the ‘getting what youneed from the healthcare team. so, 1 to 2 weeks after receiving the coping together,we did call them, we did institute the orientation phone calls for this pilot and couples alsoreceived a follow up phone call every 2 weeks to really monitor use. so we were very muchfocused on process evaluation as well in terms

of knowing the extent to which couples wereusing the booklets particularly given all the changes that we had to make. mec couplesare control group. they were mailed 2 booklets that were already available in the communitythrough the cancer council and this was ‘understanding prostate cancer’ and ‘caring for someonewith cancer’. they received the same number of phone calls and they were all similar inintent and content. none of the phone calls had a therapeutic context, they were conductedby a trained research assistant in terms of the interview guide but this was not a researchassistant that was trained in terms of any therapeutic interventionso the close monitoring of the couples use of coping together, we found that, in ourpilot and i’m still analyzing this data

in terms of characterizing patterns of useand understanding that it is a different sample but we are quite encouraged because 70% atthis point in time of our couples actually used coping together in a way uh…in theway that in which coping together was designed. so that is encouraging to usthis is phase 2 pilot so i can only present trends in efficacy. i do really want to emphasizethat. this table does show that, for coping together partners, there are a number of potentialbenefits of our larger trial will hopefully confirm some of these but definitely in termsof sharing with you some of the potential benefits, these include increasing relationshipsatisfaction and self-caring initiative and reduced caregiver burden and negative appraisalof caregiving. so to a certain extent, that

is encouraging to our patients. so phase 3,our large randomized-controlled trial is ongoing at this point in time. i do hope that in thenear future, i have the opportunity to present these to you so thank you very much.