Grant Proposal: Funding a Program Evaluation of the Healing Foods Program at UCSD Moores Cancer Center

Transcription

1 Grant Prpsal: Funding a Prgram Evaluatin f the Healing Fds Prgram at UCSD Mres Cancer Center by Viveca Taylr A paper submitted t the faculty f the University f Nrth Carlina at Chapel Hill in partial fulfillment f the requirements fr the degree f Master f Public Health in the Department f Nutritin Chapel Hill, NC December 7, 2017 Apprved by: Melinda A. Beck, PhD Date

2 UCSD MOORES CANCER CENTER HEALING FOODS PROGRAM GRANT APPLICATION: PAR ABSTRACT The Healing Fds Prgram (HFP) seeks t link patients and caregivers at University f Califrnia at San Dieg (UCSD) Mres Cancer Center with evidence-based nutritin infrmatin thrugh infrmatinal seminars, fd demnstratins and a nurishment cart fr patients receiving therapies in the infusin and radilgy centers. The bjective f this prgram is t imprve quality f life fr patients underging cancer treatment. Mre specifically, the prgram has established the fllwing specific aims: 1. Increase the number f active HFP participants (thse wh have attended at least ne class ver the last six mnths) t 300% f the number f active participants at baseline (targeted cmpletin date f June 30, 2019). 2. Cmplete a frmal evaluatin f the HFP that assesses the prgram s ability t imprve subjective quality f life measures fr patients in treatment (targeted cmpletin date f June 30, 2020). In rder t achieve these bjectives, the HFP plans t expand its participant reach thrugh new prgram fferings, a targeting marketing campaign, and a weekly nurishment cart fr patients receiving therapies at the cancer center. In additin, the HFP plans t cnduct a frmal evaluatin f its efficacy at meeting its stated bjectives. This evaluatin will invlve administering the WHO-5 well-being screener, a validated tl fr assessing subjective quality f life measures, t patients attending classes. Surveys will be administered at baseline (at the start f each class) and three weeks after the classes via an nline survey platfrm. The results f the surveys will be analyzed t assess whether the HFP is making prgress tward meeting its lngterm bjectives, as well as t generate lessns learned fr ther cancer centers lking t develp nutritin educatin prgrams fr patients and caregivers. PROJECT NARRATIVE The evaluatin f the Healing Fds Prgram (HFP) prject seeks t cntribute t the field f public health by prviding guidance fr ther cancer centers develping cmparable nutritin educatin prgrams. This will have the lng-term impact f imprving quality f life fr patients underging cancer treatment.

3 BUDGET JUSTIFICATION Persnnel Justificatin Prgram Directr: Christine Zumas, MS/RD Percent Effrt: 2.4 calendar-year persn-mnths Knwledge, Skills & Experience: Ms. Zumas btained her MS in Nutritinal Science frm Pennsylvania State University. She has verseen the Healing Fds Prgram (frmerly the Healthy Eating Prgram) at UCSD Mres Cancer Center since its inceptin. She als teaches nutritin science at varius San Dieg universities and clleges. Rles: The Prgram Directr is respnsible fr prgram versight and decisin-making; interfacing with the Bard f Visitrs and crprate partners; internal (within UCSD Health) and external utreach; and fr prviding direct supervisin t the Prgram Manager. The Prgram Directr will als teach at least ne nutritin seminar per week. Prgram Manager: Currently Hiring Percent Effrt: 6.0 calendar-year persn-mnths Desired Knwledge, Skills & Experience: The Prgram Manager will have an academic degree and/r prfessinal accreditatin in nutritin (preferably a Registered Dietitian). The Prgram Manager will als have previus experience in prgram management, preferably in a public r private healthcare cntext. Rles: The Prgram Manager is respnsible fr general prgram administratin, including managing registratin, marketing, preparatin fr classes (with the exceptin f the respnsibilities f the culinary instructr), and rganizing vlunteer staffing. The Prgram Manager will be respnsible fr teaching nutritin seminars nt taught by the Prgram Directr (based n an agreed-upn schedule). The Prgram Manager will versee the Research Assistant during the prgram evaluatin (Budget Perid 2). Culinary Instructr: Currently Hiring Percent Effrt: 2.4 calendar-year persn-mnths Desired Knwledge, Skills & Experience: The Culinary Instructr must have an academic degree in culinary arts. In additin, he r she must have experience and skills in grup educatin. Rles: The Culinary Instructr will be respnsibility fr develping the curriculum and preparing fr the fd demnstratins. He r she will teach at least fur fd demnstratins per mnth, and will be respnsible fr managing vlunteers assisting with the demnstratins. Research Assistant: Will Be Hired Prir t Budget Perid 2 Percent Effrt: 2.4 calendar-year persn-mnths Desired Knwledge, Skills & Experience: The research assistant will be a graduate student pursuing a degree in public health, nutritin, r a related field. The research assistant will be prficient at data entry and statistical analysis. Rles: The Research Assistant will be respnsible fr managing administratin f the baseline and fllw-up surveys (including cllecting infrmed cnsent frm participants), as well as fr data entry and analysis. He r she will reprt t the Prgram Manager and Prgram Directr. Vlunteers Percent Effrt: N/A Desired Knwledge, Skills & Experience: The HFP will recruit vlunteers thrugh Mres Cancer Center Vlunteer Services. All vlunteers cmplete extensive nline training and an in-persn

4 rientatin that cvers prfessinalism, interacting with patients, and safety precautins, amng ther tpics. N additinal special skills are required. Rles: The vlunteers will assist the Culinary Instructr with the fd demnstratins, including preparatin, check-in and clean-up. In additin, the vlunteers will take the nurishment cart dwn t the infusins and radilgy centers t prvide snacks t patients and prmte the HFP s class fferings. Additinal Narrative Justificatin Equipment All kitchen equipment is prvided in-kind by Mres Cancer Center. Supplies A ttal f $5,400 per year is budgeted fr supplies. This includes $1,200 per year ($100 per mnth) fr ffice supplies, such as paper, binders, pens/pencils, envelpes, flders and printer cartridges. This als includes anther $1,200 per year ($100 per mnth) allcated fr prfessinal printing services t print ur mnthly marketing materials (including fliers, brchures and stackcards). The supplies ttal includes $600 per year ($50 per mnth) fr kitchen supplies, including dispsable dishes, utensils, napkins and glves; plastic bags, plastic wrap and fil fr string fd; and cleaning supplies. The supplies ttal includes $2,400 per year ($200 per mnth) fr ingredients needed fr the fd demnstratins. This is based n an estimate f $50 per class fr fur classes per mnth. Snacks fr the nurishment cart are prvided in-kind by ur crprate partners. Please see letters f supprt attached t this grant applicatin. Cmputers, printers and cpiers are prvided in-kind by Mres Cancer Center. Gas Mileage A ttal f $100 is budgeted fr mileage expenses. This is based n a calculatin f $0.50 per mile fr 200 miles, required fr purchasing ingredients and supplies fr the fd demnstratins, as well as cmmunity utreach and ther ff-site events. Other Expenses All ther expenses are prvided in-kind. This includes ffice space (wrkstatins), and facilities fr classes (cnference rm space fr seminars and kitchen space fr fd demnstratins). The WHO-5 screener is freely available fr public use. Nte: PHS 398 Mdular Budget Frm (fr prjects requesting less than $250,000 per budget perid) nly requires a Persnnel Justificatin, but fr the mck grant applicatin, a full budget justificatin was develped.

5 RESEARCH PLAN Specific Aims A 2012 systematic review f 26 studies fund a strng bdy f evidence supprting the crrelatin between pr nutritin status and impaired quality f life during cancer treatment. 1 Thus, cancer centers natinwide are taking steps t incrprate nutritin educatin and cunseling prgrams int their patient fferings, but very few ffer cmprehensive nutritin educatin and even fewer incrprate fd demnstratins int their nutritin educatin initiatives, nr d many ffer educatin thrugh all phases f cancer treatment and survivrship. The UCSD Mres Cancer Center Healing Fds Prgram seeks t pilt a prgram that fills these critical gaps in patient fferings. Our rtating curriculum includes nutritin seminars, fd demnstratins and ne-n-ne patient encunters via ur nurishment cart fr patients receiving therapies in the infusin and radilgy centers. We hypthesize, based n a grwing bdy f evidence supprting the use f nutritin interventins t imprve cancer patient utcmes 2,3,4,5, that ur unique prgram fferings will imprve subjective measures f wellbeing amng patients in treatment. We plan t cnduct a frmal prgram evaluatin t test these hyptheses and t publish the evaluatin results as guidance t ther cancer centers implementing cmparable prgrams t supprt the nutritin needs f patients as they g thrugh treatment. We have established the fllwing specific aims: Aim 1 will increase the number f active HFP participants (thse wh have attended at least ne class ver the last six mnths) by 300% relative t baseline (targeted cmpletin date f June 30, 2019). We currently estimate ur baseline participant ppulatin t be apprximately 300 and therefre aspire t increase active participatin t apprximately 900 participants. This will be accmplished thrugh new prgram fferings, a targeted marketing campaign, and a nurishment cart fr patients receiving therapies at the cancer center. Aim 1 will ensure that the HFP s participant base is sufficient in reach and representatin f ur target ppulatin in rder t supprt ur prgram evaluatin. Aim 2 will cmplete a frmal prgram evaluatin f the HFP (targeted cmpletin date f June 30, 2020). This will be accmplished thrugh baseline (prir t class attendance) and fllw-up (pst-class) assessments f subjective wellbeing measures amng patients currently in treatment. Aim 2 will test ur research hypthesis and generate lessns learned fr ther cancer centers lking t implement cmparable prgrams. The Healing Fds Prgram takes an innvative, hands-n apprach t educating cancer patients and caregivers n nutritin thrugh all phases f cancer treatment and survivrship. We anticipate that the prgram evaluatin will evidence meaningful imprvement in quality f life amng patients in treatment. The evaluatin will generate valuable assessment data t guide ther cancer centers with implementatin f cmprehensive nutritin educatin prgrams. Cnsequently, the expected impact f this prgram is cntributin f knwledge t the field f educatin n nutritin and cancer, with the lng-term gal f imprving the mental and physical wellbeing f cancer patients during treatment.

6 Research Strategy Significance The prevalence f malnutritin amng cancer patients is estimated t be between 15% and 80% f patients. 6 There is a strng bdy f evidence supprting the crrelatin between pr nutritin status during cancer treatment and impaired quality f life. Indeed, a 2012 systematic review fund a statistically significant inverse relatinship between quality f life measures and pr nutritin status in 24 f 26 studies cnsidered 1. Thus, it is critical that cancer centers implement accessible prgrams designed t address the nutritin needs f patients during treatment. The Healing Fds Prgram (HFP) at UCSD Mres Cancer Center ffers free nutritin educatin t patients and caregivers in an effrt t imprve quality f life during treatment. The prgram s missin is predicated n the strength f the evidence supprting the crrelatin between nutritin interventins fr patients prir t r during cancer treatment and imprved quality f life and health utcmes, particularly fr patients with clrectal 3,5, and head and neck cancers 2,4. The prgram seeks t cntribute t scientific knwledge by publishing the results f ur prgram evaluatin t guide ther cancer centers implementing cmparable prgrams t supprt the nutritin needs f patients receiving cancer treatment. Innvatin The HFP challenges current clinical practice paradigms fr nutritin and cancer. Unlike traditinal utpatient nutritin cunseling, participatin in the HFP des nt require a physician referral. This prvides patients with an increased perceptin f cntrl ver their clinical experience by allwing them t bypass sme f the bureaucratic challenges f the health system. In additin, by ffering fd demnstratins, the prgram seeks t prvide evidence-based nutritin educatin in a practical cntext. While many patients may have a general idea f what cmprises a healthy diet, many lack the self-efficacy r culinary knwledge t implement sund nutritin principles in the kitchen. Cnsequently, the prgram seeks t make nutritin educatin mre apprachable t patients and caregivers by prviding the knwledge and skills necessary t prepare simple, healthy recipes at hme. The HFP seeks t imprve in several ways current mdels fr nutritin educatin interventins fr cancer patients. The HFP ffers a multimdal apprach t nutritin educatin thrugh several different patient tuchpints: nutritin seminars, fd demnstratins and a nurishment cart fr patients receiving therapies in the infusins and radilgy center (an pprtunity fr shrt patient cnsultatins with a dietitian r dietetic intern). All f ur fferings are free, d nt require physician referrals and are lcated within the cancer center, mitigating ptential access issues. Finally, the prgram expands the breadth f typical nutritin educatin fferings with nutritin guidance fr all phases f cancer treatment and survivrship. There are numerus advantages t the HFP s nvel apprach t nutritin prgramming fr cancer patients. Bypassing the physician referral system increases patient autnmy and perceptin f cntrl ver their healthcare. Offering the classes at n cst (dnatin-based) t participants at a lcatin accessible via public transprtatin eliminates ptential sciecnmic barriers. The discussin-based class frmat is designed t encurage cnversatin, with the gal f fstering a supprt cmmunity between patients and facilitatrs. Finally, ffering fd demnstratins t supplement ur seminar fferings translates nutritin educatin frm knwledge t practical skillsets that can be applied in hme kitchens.

7 Apprach We plan t first grw the HFP s participant base (Aim 1) and then t evaluate the prgram s efficacy in imprving quality f life fr patients receiving treatment fr cancer (Aim 2). Aim 1 Increase Prgram Participatin: Strategy The prgram s grwth strategy is cmprised f the fllwing cmpnents: New fd demnstratin and nutritin seminar fferings Strategic marketing via mailing (via ) lists, prgram fliers, and cmmunity utreach events Nurishment cart fr patients receiving therapies at the cancer center We will cnduct an nging prcess evaluatin using ur registratin sftware t assess ur prgress in achieving Aim 1. Methdlgy Analysis Ptential Issues Experimental Design: We will use a nn-experimental pre-pst evaluatin design t assess ur prgress in achieving Aim 1. This evaluatin will be perfrmed ver a ne-year perid (June 30, 2018 t June 30, 2019). Feasibility: The primary high-risk aspect f ur chsen methdlgy is cncern ver HIPAA cnsideratins, which we will mitigate by annymizing all data nce it is dwnladed frm ur registratin sftware and ensuring adequate infrmatin security prtcls are in place t prtect cllected data. Rigr and Reprducibility: Scientific Premise: See Significance sectin abve. Scientific Rigr: Because ur Aim 1 evaluatin relies exclusively n quantitative registratin data directly frm the registratin sftware, there is a lwer risk f intrducing bias during the administrative and analytical prcedures. We will develp a standard prtcl fr data entry, data analysis and data interpretatin. We will ensure that all data is annymized and that data analysis is perfrmed and interpreted by tw independent parties. Relevant Variables: We plan t cllect the fllwing demgraphic infrmatin as part f ur class registratin prcess: whether the participant is a first time registrant (in rder t assess whether we are expanding ur reach); zipcde (as a prxy fr incme status); and whether the participant is a patient, caregiver r ther (as well as which San Dieg hspital they are being treated at because ur classes are nt limited t Mres Cancer Center patients). We will expand ur data cllectin during the registratin prcess t include age, gender and ethnicity. We feel that these additinal variables will infrm ur marketing strategy, as well as prvide a snapsht f the reach and representativeness f ur participant ppulatin fr ur prgram evaluatin (Aim 2). Data Cllectin: Our nline registratin sftware, HS Events, autmatically tracks registratin and class attendance, with additinal functinality t cllect demgraphic data (as utlined under Relevant Variables abve). Data Analysis: The registratin data is peridically dwnladed t a spreadsheet and added t ur database (this prcess is already in place at the HFP). T address HIPAA cncerns, all data will be annymized nce dwnladed frm HS Events. In rder t measure ur prgress twards meeting Aim 1, we will cllect participant data at baseline (June 30, 2018) and then mnitr ur grwth during the evaluatin perid. N additinal analysis is required. Data Interpretatin: An independent party frm the persn perfrming the cllectin and analysis will interpret the data. This prcess will be perfrmed n an nging basis t infrm the marketing campaign. We identified the issue f walk-ins and n-shws as a ptential challenge fr accurate mnitring f ur prgress twards meeting Aim 1. In rder t mitigate this issue, we have nted that HS Events has the functinality t mark class attendance fr pre-registered participants.

8 Fr walk-in participants, we have develped an alternative manual prcedure t cllect the demgraphic infrmatin we need; this infrmatin can be entered int HS Events t ensure that we have accurate class attendance data. Benchmarks fr Success Reach: Our first benchmark fr success will be expanding ur reach t meet the gal established in Aim 1: increasing the number f active HFP participants (thse wh have attended at least ne class ver the last six mnths) by 300% relative t baseline. Prgram reach will be assessed n an nging basis during the prgram grwth phase t ensure that we are n-track t meet Aim 1 by June 30, Representativeness: Our secnd benchmark fr success will be t maximize hw representative ur participant base is f ur target ppulatin (patients at Mres Cancer Center). While the HFP classes are available t the public, we are fremst a service fr Mres patients and caregivers. Cnsequently, we have set a gal t have 80% f ur active participant base be Mres patients and caregivers. Prgram representativeness will be assessed n an nging basis during the prgram grwth phase t infrm and tailr ur marketing campaign. Alternative Apprach Aim 2 Prgram Evaluatin If we are nt n-track t meet ur benchmarks fr success, ur alternative strategy will be t hld a fcus grup with ur target ppulatin t better understand the best way t increase prgram participatin, whether it be t change ur marketing strategy, adjust ur class schedule t better accmmdate patient needs r t change ur class fferings. If an adjustment in marketing strategy is needed, we will als cnsult with Prgram Develpment wh assist with develpment and grwth f Mres Cancer Center prgramming. Strategy We plan t cnduct a frmal prgram evaluatin f the HFP t assess whether it is leading t meaningful imprvement in subjective measures f wellbeing amng patients in treatment. This will be accmplished thrugh a survey fr prgram participants administered at baseline (beginning f class) and fllw-up (pst-class). Methdlgy Experimental Design: We will use a nn-experimental pre-pst evaluatin design t assess ur prgress in achieving Aim 2. This evaluatin will be perfrmed ver a ne-year perid (June 30, 2019 t June 30, 2020). Feasibility: The primary high-risk aspect f ur chsen methdlgy is cncern ver HIPAA cnsideratins, which we will mitigate by annymizing all data and ensuring adequate infrmatin security prtcls are in place t prtect cllected data. We will btain infrmed cnsent frm participants prir t survey administratin. Rigr and Reprducibility: Scientific Premise: See Significance sectin abve. Scientific Rigr: We will develp a standard prtcl fr baseline and fllw-up survey administratin, data entry, data analysis and data interpretatin (as well as prtcls fr nnrespnse fllw-up and ther cntingencies). T ensure the mst accurate results, we will be using the WHO-5, a validated tl 7 fr subject assessments f wellbeing. Survey administratin will be managed by a research assistant whse jb functins are independent f class administratin. Relevant Variables: We have identified the fllwing variables as ptentially relevant t interpretatin f ur results: age, gender, ethnicity, type and stage f cancer, type f therapy, number f runds f therapy received in the past (t assess whether previus experiences with therapy impact subjective wellbeing scres), type f class attended (seminar vs. fd demnstratin) and number f classes ver the ne-year perid. We will cllect infrmatin n demgraphics, as well as the type and stage f cancer and therapy, as fields n ur surveys. We will track the number f classes each participant has attended using data frm HS Events.

9 Analysis Data Cllectin: We will administer the survey t all participants at the beginning f each class nce we btain infrmed cnsent. Patients will cmplete the shrt five-questin WHO-5 screener. Three weeks after class, we will send cnsenting participants a fllw-up survey via an nline survey platfrm with the same five-questin screener t assess whether the classes lead t meaningful imprvement in subjective measures f wellbeing. This will be perfrmed fr all cnsenting participants fr all classes (fd demnstratins and seminars), which may prvide multiple data pints fr the same participant ver time. Data Analysis: Data will be entered and maintained in a centralized database by the research assistant. We will first filter fr surveys received fr patients (at Mres Cancer Center r anther facility). While we are cllecting baseline surveys frm all participants (t avid singling ut patients in class), ur target ppulatin is patients receiving treatment. Fr the target ppulatin, we will input the results f the survey, as well as the demgraphic data cllected. Fllw-up surveys will nly be sent t ur target ppulatin (current patients). Data Interpretatin: We will perfrm cmparisns between baseline and fllw-up data, as well as trends fr patients wh attend multiple classes. Additinally, we will examine hw ur relevant variables (type and stage f cancer, treatment type, rund f treatment, type f class and number f classes attended) impact ur results. We will use the results f ur data interpretatin t infrm lessns learned fr ther cancer centers lking t implement cmparable prgrams. Ptential Issues We identified the ptential issue f cllecting unnecessary data fr class participants that are nt in ur target ppulatin. T mitigate infrmatin security cncerns, all unused surveys will be immediately shredded in a HIPAA-cmpliant manner. T avid cllecting unnecessary fllw-up data, we will nly be sending the surveys t ur target ppulatin (patients). We als identified the issue f missing data as a ptential issue. We will fllw-up persnally with participants wh d nt cmplete fields n the manual baseline survey. Fr participants wh d nt cmplete the fllw-up survey, we will them a survey reminder three days later, fllwed up by a phne call an additinal three days later. If we are nt able t cllect a fllw-up survey within fur weeks f class attendance, we will discard the baseline survey. Benchmarks fr Success Our first benchmark fr success will be t cllect a rbust dataset t supprt ur prgram evaluatin. We have established a benchmark gal f 385 evaluatin participants (cmpleted bth baseline and fllw-up surveys) in rder t achieve 95% cnfidence with a 5% cnfidence interval. Given ur current participatin rate and number f classes ffered per mnth (typically eight t 10), as well as ur anticipated expansin with Aim 1, we believe this gal is realistic. Our secnd benchmark fr success will be t cmplete data analysis and interpretatin f the cllected data. Alternative Apprach Similar t ur alternative apprach fr Aim 1, if ur preliminary data is nt evidencing meaningful imprvement in wellbeing scres, we will hld fcus grups with survey participants t better understand what might be preventing the results we were anticipating. We will use the results f the fcus grup t identify the changes we need t make (t the prgram itself r t ur evaluatin apprach). Based n these findings, we will develp an alternative strategy t ensure that we meet the bjective established in Aim 2.

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