Manage the Symptoms, Support the Needs: Impacting Patient

Oncology Nursing Society 43nd Annual CongressMay 17–20, 2018 • Washington, DC 1Advanced Practice

1. Onco-Nephrology: A New Cancer Nursing SubspecialtyAmanda Hughes, ANP-BC, MSc, OCNMemorial Sloan Kettering New York City, NY

2. The Role of Nurse Clinicians and Advanced Practice Providers in the Management of Supportive Oncology Needs and Treatment- Related Side Effects for Women With Gestational Trophoblastic Neoplasia (GTN)Nancy Anderson, CNPRobert H. Lurie Comprehensive Cancer CenterChicago, IL

3. Hepatitis B Outbreak: Can We Prevent It?Patricia Karwan, DNP, APRN-BCCare New EnglandCranston, RI

4. Self-Care Support for Patients with Gastrointestinal Cancer: iCancerHealthNina Grenon, DNPDana-Farber Cancer InstituteBoston, MA

Manage the Symptoms, Support the Needs: Impacting Patient OutcomesSaturday, May 19 • 9:45–11 am

Note one action you’ll take after attending this session: ____________________________________________________

________________________________________________________________________________

ONS 43rd Annual Congress

Advanced Practice (Hughes) 1

Onco-nephrology: a New Cancer Nursing Subspecialty

Date: May 19th 2018

Presenter: Amanda Hughes ANP-BC, MSc, OCN

Nurse Practitioner Onco-Nephrology,

Memorial Sloan Kettering Cancer Center

[email protected]

Onco-Nephrology

• Review of renal function

• Review of nephrotoxicity, standard therapies

• Focus on novel therapies

• Case studies

• Future directions

Review of kidney function



Criteria for Kidney Injury: Discrepancies

• AKI can be diagnosed if any one of the following is present: KDIGO

• Increase in SCr by ≥0.3 mg/dl (≥26.5 μmol/l) within 48 hours; or

• Increase in SCr to ≥1.5 times baseline, which has occurred within the prior 7 days; or Urine volume <

0.5 ml/kg/h for 6 hours.

Stages of AKI• Stage 1: 1.5-1.9 times baseline or greater than or equal to 0.3mg/dl

increase in serum creatinine

• UOP <0.5mls/kg/hr for 6-12 hours

• Stage 2: 2.0 – 2.9 times baseline

• UOP <0.5mls/kg/hr great than or equal to 12 hours

• Stage 3: 3.0 times baseline or greater than or equal to 4mg/dl

• UOP <0.3mls/kg/hr for greater than or equal to 24 hours OR anuric for 12 hours

• OR initiation of renal replacement therapy

• <18 years old GFR<35mls/min

CKD Stages• Stage 1 Slightly diminished function; kidney damage with normal or

relatively high GFR (≥90 ml/min/1.73 m2) and persistent albuminuria. Kidney damage is defined as pathological abnormalities or markers of damage, including abnormalities in blood or urine tests or imaging studies.

• Stage 2 Mild reduction in GFR (60–89 ml/min/1.73 m2) with kidney damage. Kidney damage is defined as pathological abnormalities or markers of damage, including abnormalities in blood or urine tests or imaging studies.

• Stage 3 Moderate reduction in GFR (30–59 ml/min/1.73 m2): British guidelines distinguish between stage 3A (GFR 45–59) and stage 3B (GFR 30–44) for purposes of screening and referral.

• Stage 4 Severe reduction in GFR (15–29 ml/min/1.73 m2)Preparation for renal replacement therapy.

• Stage 5 Established kidney failure (GFR <15 ml/min/1.73 m2), permanent renal replacement therapy,] or end-stage kidney disease



RIFLE• The RIFLE criteria, proposed by the Acute Dialysis Quality Initiative

(ADQI) group, aid in assessment of the severity of a person's acute kidney injury. The acronym RIFLE is used to define the spectrum of progressive kidney injury seen in AKI

• Risk: 1.5-fold increase in the serum creatinine, or glomerular filtration rate (GFR) decrease by 25 percent, or urine output <0.5 mL/kg per hour for six hours.

• Injury: Two-fold increase in the serum creatinine, or GFR decrease by 50 percent, or urine output <0.5 mL/kg per hour for 12 hours

• Failure: Three-fold increase in the serum creatinine, or GFR decrease by 75 percent, or urine output of <0.3 mL/kg per hour for 24 hours, or no urine output (anuria) for 12 hours

• Loss: Complete loss of kidney function (e.g., need for renal replacement therapy) for more than four weeks

• End-stage kidney disease: Complete loss of kidney function (e.g., need for renal replacement therapy) for more than three months

CTCAE V4

• Consider CTCAE 4.0

• Grade 1 creatinine level increase of >0.3, or creatinine 1.5 – 2.0 above baseline

• Grade 2 creatinine 2-3 x above baseline

• Grade 3 Creatinine >3 x above baseline or >4mg/dl, hospitalization indicated.

• Therefore a baseline creatinine of 0.8 would need to rise to 1.6-2.4 before it was grade three in clinical trial work but would only need to be 1.2 to actually be AKI in nephrology

• Is nephrotoxicity under reported?

Nephrotoxicity of Common Agents

• Ifosfamide

• Nature of Injury: proximal tubular acidosis

• Presentation: Fanconi syndrome, glucosuria with normoglycemia, renal phos, mag and potassium wasting, hypouricemia

• Management: limit dose, consider risk factors such as prior platinum therapy, prior renal irradiation, nephrectomy or other renal injury.

• Discontinue drug, renal injury may progress after discontinuation leading to ESRD (Berns JS, Haghighat A et al. Severe

irreversible renal failure after Ifosfamide treatment. A clinicopathologic report of two patients. Cancer 76:479-500. 1995)




• Cisplatin

• Nature of Injury: Tubular

• Onset within 3 hours lasts up to two years.

• Presentation: elevated serum creat, bland UA, minimal proteinuria

• Magnesium wasting may be prolonged up to 6 years

• Renal salt wasting may present late at 2- 4 months after cisplatin

• Intrinsic renal condition FeNa >3%

• Muddy brown casts ATN

• Management: aggressive hydration may reduce incidence, mannitol and loop diuretics no clear benefit, amifostine limited due to cost and concerns for diminished anti tumor effect.

• (Yao X, PanichpisalK et al. Cisplatin nephrotoxicity: A review. Am j Med Sci 334:115-124, 2007

• Launay-Vacher, Rey JB et al. Prevention of cisplatin toxicity: State of the art and recommendations from the European Society pf Clinical Pharmacy Special Interest Group on cancer Care. Cancer ChemotherPharmacol, 61: 903-909, 2008)


• Methotrexate

• Nature of Injury: direct precipitation only in doses higher than !gm/m2

• Presentation: oliguric or non oliguric AKI, bland UA, no proteinuria

• Management: alkalinize urine, aggressive hydration 2.5-3.5L/24 hours, avoid PCN, sulfisoxazole, NSAIDS may potentiate nephrotoxicity,

• Leucovorin rescues until MTX level les than 100

• Consider Glucarpidase but little evidence and only effects extracelluar levels of methotrexate. Use only if standard therapies have failed. (Cavone JL, Yang D, Wang A. Glucarpidase intervention for delayed methotrexate clearance. Ann Pharmacother 48: 897-907, 2014)


• Gemcitabine

• Nature of Injury: thrombotic microangiopathy

• Presentation: new onset AKI, microangiopathic hemolytic anemia, new or worsening hypertension.

• Management: withdraw drug, 28% complete recovery 48% partial or stable renal function

• Options include plasmaphereses not shown to be better than conservative management

• Eculizumab response is similar to supportive care alone. (Stark M, Wendtner CM. Use of eculizutmab in refractory gemcitabine-induced thrombotic

microangiopathy. Br J Hematology 164: 894-896,2014

• Al Ustwani O, Lohr J et al. Eculizimab therapy for gemcitabine induced hemolytic uremic syndrome: Case series and concise review. J Gastrointestinal Oncolo 5: E30-E35, 2014

• Tsai HM, Kuo E. Eculizumab therapy leads to raid resolution of thrombocytopenia in atypical hemolytic uremic syndrome.Adv Hematol 2014: 295-323, 2014)

.




• Bevacizumab VEGF

• Nature of Injury: thrombotic microangiopathy

• Presentation: new or worsening hypertension, proteinuria, elevated creat, MAHA, low haptoglobin, high lactate dehydrogenase

• Management: before withdrawing drug consider that current evidence suggests HTN may be a marker of response, treat BP >140-90 or DBP >20mmHg above baseline

• Consider ACE/ARB if proteinuria

• Control BP and continue

• STOP for nephrotic syndrome, HTN with end organ damage, MAHA, renal insufficiency

• ( Rixe O, Billemont B, izzedine H. Hypertension as a predictive factor of Sunitinib activity. Ann Oncol 18: 1117, 2007

• Rixe O, Dutcher JP et al. Association between diastolic BP > 90mmHg and efficacy in patiens with metastatic renal cell cancer receiving axitinib. Ann Oncol 19 (supple 8): viii 189, 2008

Nephrotoxicity of Novel Agents

• Cetuximab

• Nature of Injury: Distal Convoluted Tubule

• Presentation: hypomagnesemia theory is that block EGFR in DCT leads to magnesium wasting.

• Severity of hypomagnesemia correlates to length of exposure to drug

• Management: DIFFICULT can require up to 6-10gms daily of IV magnesium but most cases resolved in 4 weeks after discontinuation of drug.

• Follow serum calcium, theory is that PTH resistance leads to hypocalcemia, will resolve as hypomagnesemia resolves

• (Schrag D et al. Cetuximab therapy and symptomatic hypomagnesemia. J Natl Cancer Inst 97 : 1221-1224, 2005

• Fakih MG, Wilding G, Lombardo J. Cetuximab-induced hypomagnesemia in patients with colorectal cancer. Clin Colorectal Cancer 6: 152-156, 2206)


• Imatinib (small molecule TKI)

• Nature of Injury: UNKNOWN thought to inhibit PDGFR

• Presentation: hypophosphatemia, theory is that this inhibits PDGFR leading to decreased calcium and phos efflux from bone, lower calcium egress leads to mild secondary hyperparathyroidism and increased renal phos losses,.

• In one study 51% of patients developed hypophosphatemia, even pts with low and normal serum phos had elevated urine fractional excretion of phos.

• Only those with low serum phos had elevated PTH levels.

• Management prompt phos repletion• (Berman E, Nicolaides M et al Altered bone and mineral metabolism in patients receiving imatinib mesylate.

N Eng J Med 354: 2006-2013, 2006)




• Ipilumumab CTLA 4 antibodies

• Fully human monoclonal antibody directed against cytotoxic T-lymphocyte antigen-4

• Nature of injury: immune mediated AKI, not common in kidney, but cases of granulomatous acute interstitial nephritis, and lupus nephritis have been reported.

• Presentation: AKI

• Management: Resolves with discontinuation of drug and steroids

• (Izzedine H, Gueutin et al. Kidney injuries related to ipilimumab. Investing in new drugs 32: 769-773, 2014

• Fadel F, El Karoui K, Knebelmann B. Anti-CTLA4 antibody-induced lupus nephritis. N Eng J Med 361: 211-212, 2009)


• Nivolumab PD1 - human programmed death receptor-1 (PD-1) inhibitor (PD-1L expressed on proximal tubular epithelial cells)

• Nature of injury: immune related

• Presentation: AKI, Acute Interstitial Nephritis

• Management: stop drug, steroids ? Duration• (OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and

periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients.)

Case study Bevacizumab

71 year old female with ovarian cancerThis is a 70 year old white female with a PMH of HTN, ulcerative colitis, stage IV high grade serous ovarian carcinoma Avastin induced nephrotoxicity manifesting as TMA and refractory HTN on multiple agents.Prior chemo includes carboplatin docetaxel May to October 2016Bevacizumab/liposomal Doxorubicin March to September 2017Admitted with Hypertensive urgency and TMA



Case study Nivolumab

69 year old male with GE junction tumor s/p PD1 inhibitor, stopped after two doses for AKI.

Creatinine from 1.3 to 3.7.

Renal biopsy showed diffuse active tubulointerstitial nephritis with focal granulomas

Case Study CART T

19 year old male with GCB DLBCLs/p CART T cell infusion

admitted to the ICU after cytokine release syndrome

Now with urine output of 10L in 24 hours

Summary

Novel therapies Watch for early signs of AKI a small rise in serum creatinine may be important.Nephrotoxicity may be under reported in novel therapies Data is emerging every dayCAR‐T ?


Advanced Practice (Anderson) 1

The Role of Nurse Clinicians & Advanced Practice Providers in the Management of Supportive Oncology Needs

and Treatment‐Related Side Effects for Women with Gestational Trophoblastic Neoplasia

Nancy J. Anderson CNP, Karen Novak CNP, Sara Covert, RN, John R. Lurain MD

John I. Brewer Trophoblastic Disease CenterRobert H. Lurie Comprehensive Cancer CenterNorthwestern University School of Medicine

Chicago, IL USA

Disclosures

• No Disclosures



Background

• Women diagnosed with gestational trophoblastic neoplasia (GTN) have an excellent prognosis with cure rates approaching 100%

• Despite the fact that full recovery is generally expected, these women are confronted with

– a potentially life‐threatening diagnosis– chemotherapy and/or surgical treatment– a delay in future pregnancy

Lurain JR Am J Obstet Gynecol 2011; 2014: 11‐18

BackgroundPsychosocial Stress

• Women with GTN experience increased levels of anxiety, anger, sadness, as well as shifts in feelings of self esteem, marital relationships, and attitudes towards future pregnancies

• Women with metastatic disease receiving multiagent chemotherapy are more likely to express emotional distress, physical problems, and concerns about fertility and pregnancy.

• The emotional impact of GTN may be protracted and lingering, combined with the fear of another gestational trophoblastic event in future pregnancy

Wenzel L., et al Gynecol Oncol 1992; 46-74

Wenzel L., et al J Reprod Med 1994; 9-163

Di Matttei VE, et al J Reprod Med 2014; 59-488

BackgroundTreatment-Related Side Effects

• Women receiving single-agent methotrexate or actinomycin D for low-risk GTN may experience stomatitis, nausea, eye dryness, rash, or pleuritis

• Women receiving multiagent chemotherapy (EMA-CO, EMA-EP, or platinum-containing regimens) for high-risk GTN experience alopecia, more fatigue and nausea, as well as occasional peripheral neuropathy and hearing loss

• Prevention strategies, early recognition, and appropriate intervention will result in minimization of toxicity, adherence to treatment, and improved quality of life

Lurain JR. Expert Opin Pharmacother 2003; 4: 1-13



Background

• An important component of treatment success in GTN is to address supportive oncology needs as well as disease and treatment-related side effects

• Patient education prior to and throughout treatment is most often the responsibility of advanced practice providers and nurse clinicians

Objectives

To provide each patient with verbal and written disease and treatment-specific education as well as employ institutional resources before, during, and after treatment of GTN which will:

• decrease stress/anxiety

• promote patient confidence in their case

• Increase compliance with treatment and follow-up

• Improve overall quality of life

Materials & Methods

• We reviewed patient educational materials available from other major trophoblastic disease centers as well as our own

• We analyzed evidence-based medicine regarding management of chemotherapy-related side effects

• We incorporated out own experiences as well as standards of care published by ONS, ASCO, and NCCN



ResultsWe developed a patient-directed, disease-specific educational binder regarding each GTN, chemotherapy treatment plan, nursing intervention for the management of treatment side effects, and supportive oncology resources, including psychological and oncofertility concerns, as well as standardized verbal communication tool

Results

Prior to initiation of treatment for GTN, the nurse clinician meets with the patient to review the booklet, go over the management plan, including possible chemotherapy-related side effects and prevention strategies, and discuss supportive oncology needs and available resources

GTN Educational Binder

My treatment• Patient-specific diagnosis (postmolar GTN, low-risk GTN, high-risk GTN, PSTT, ETT)• Plan of care

– Chemotherapy protocol– Surgery

Personal Notes/Documents• space to write notes/questions or journal • section for Power of Attorney for Healthcare




Treatment Side Effects• Signs, symptoms, and management tips for:

– Infection, fatigue, bleeding/clotting, nausea/vomiting, hair loss/thinning, eye disorders, diarrhea, constipation, mouth sores, peripheral neuropathy, skin and nail changes, diet and nutrition, cognitive changes, sexual health, fertility

• Medication check lists for: – Preventing allergic reactions to chemotherapeutic agents– Antiemetics– Constipation action plan– Pain management– Stomatitis prevention/treatment


Tests and ProceduresLabs and imaging results and how to interpret them

Patient RecordsSection dedicated for patient to keep records of hCG levels, nursing discharge instructions, and incidental

information

ScheduleCalendar for patients to keep track of appointments for clinic visits and chemotherapy


Supportive Resources Available at the Robert H. Lurie Comprehensive Cancer Center

• Social worker• Psychiatry team• Nutrition services• Fertility preservation program• Financial services• Support group / pastoral services / advance directive experts• Care for the care giver advice




Chemotherapy Regimens

Methotrexate

Actinomycin D

EMA-CO, EMA-EP

BEP, VIP, ICE, TP/TE

G-CSFs used to prevent neutropenia and treatment delays

Conclusions

Development of a patient-directed, disease specific booklet regarding each GTN, chemotherapy treatment plans, nursing interventions for the management of treatment related side effects, and supportive oncology resources:

• Improves patient outcomes

• Maintains consistency in treatment standards of care

• Diminishes patient anxiety related to treatment and outcomes

• Increases patient compliance with treatment and side effect management

Key Takeaways• APPs and nurses play a key role in the education of Gestational

Trophoblastic Neoplasia (GTN) patient's on their disease, chemotherapy regimens, symptom management, and fertility navigation.

• An important component of treatment success in the GTN GTN is to provide written and verbal disease and treatment-specific education as well as supportive oncology resources.

• An education booklet can decrease stress/anxiety, promote confidence in patient case, increase compliance with treatment and follow-up and especially improve overall quality of life.



ReferencesDi Matttei VE, et al. An investigative study into psychological & fertility sequelae of gestational trophoblastic disease: The impact on patients’ perceived fertility, anxiety, and depression. Journal of Reproductive Medicine (2014) http://doi.org/10.1371/journal.pone.o12. 59-488

Ireson, RGN., et al Evolution of a Specialist Gestational Trophoblastic Disease Service with a Major Nursing Component: The Sheffield, United Kingdom, Experience. Journal of Reproductive Medicine (2013); 195-198.

Lurain JR. Pharmacotherapy of gestational trophoblastic disease. Expert Opinion on Pharmacotherapy, (2003); 4: 1-13

Lurain JR Gestational trophoblastic disease I: epidemiology, pathology, clinical presentation and diagnosis of gestational trophoblastic disease, and management of hydatidiform mole. American Journal of Obstetrics & Gynecology, 2011; 2014: 11-18

Lurain JR. Gestational trophoblastic disease II: classification and management of gestational trophoblastic neoplasia. American Journal of Obstetrics & Gynecology, 2011; 11-18

Polovich, M., Olsen, M. & LeFebvre, K., Chemotherapy and Biotherapy Guidelines. Oncology Nursing Society (2014), 473 pages

Wenzel L., et al. The psychological, social, and sexual consequences of gestational trophoblastic disease. Gynecologic Oncology, (1992); 46:1 74-81.

Wenzel L., et al Quality of Life after Gestational Trophoblastic Diseases. Journal of Reproductive Medicine 1994; 9-163


Advanced Practice (Karwan) 1

Hepatitis B Screenings Prior to Initiation of Rituximab Treatment

Patricia Karwan DNP, APRN‐BC

Introduction

WHY LOOK AT HEPATITIS B AND RITUXIMAB?

Hepatitis B Virus (HBV) reactivation has occurred in patients with prior HBV exposure who are later treated with drugs classified as CD20‐directed cytolytic antibodies, including rituximab.

Some cases have resulted in fulminant hepatitis, hepatic failure, and death.



Disclosures Nothing to disclose

Objectives1. To evaluate patients receiving rituximab to see

if Hepatitis B titers are being checked prior to treatment initiation.

2. To evaluate if patients receiving rituximab that were tested, returned with a positive result‐potentially changing treatment protocols.

3. To evaluate need of policy change to ensure Hepatitis B titers are checked prior to ordering treatment

MethodsRetrospective chart review:

Assessing documentation related to any screening for Hepatitis B prior to initiation of rituximab therapy

Inclusion criteria: 1. gender

2. age

3. oncology or non‐oncology diagnosis

4. new patients seen in outpatient infusion unit that started treatment in 2016



Results Characteristics noted in chart review from 2016:

45 patients‐ 44 patients over age of 40

31 females and 14 males

14 patients were screened for Hepatitis B prior to initiation of treatment (9 female, 5 male)

12 of 14 patients had oncologic diagnosis

18 patients with oncologic diagnosis27 patients with non‐oncologic diagnosis

1 patient converted to a positive Hepatitis B result after initiation of Rituximab

Hepatitis B Screening prior to Rituximab

20‐29 30‐39 40‐49 50‐59 60‐69 70‐79 80‐89 90‐99

0

2

4

6

8

10

12

14

16

18Patient Age


Male Female

0

5

10

15

20

25

30

35

40Gender




012

345

678

910

Diagnosis

Conclusion There is an increased need to monitor and screen patients receiving rituximab due to the potential re‐activation of Hepatitis B for any patient with a prior exposure.

Data for 2016 showed that 12 of the 18 patients (67%) of patients with an oncology diagnosis were screened, but we still had 33% without screening.

Recommendations: Policy change to promote the need for all patients (oncologic or non‐oncologic) to be screened for Hepatitis B titers prior to initation of rituximab for treatment.

Key Takeaways Hepatitis B reactivation has occurred with drugs classified as CD 20 directed cytolytic antibodies.

Some of the drugs that are CD 20 directed antibodies include Rituximab.

Hepatitis B screening should be performed prior to the administration of the commonly used drug Rituximab.



References Tsutsumi, Y., Ogasawara, R., Kamihara, Y., Ito, S., Yamamoto, Y., Tanaka, J., Asaka, M., & Imamura, M. (2010). Rituximab administration and reactivation of HBV. Hepatitis Research and Treatment, Article 182067. doi:10.1155/2010/182067

Hay, A. E., & Meyer, R. M. (2012). Hepatitis B, rituximab, screening, and prophylaxis: Effectiveness and cost effectiveness. Journal of Clinical Oncology, 30(26), 3155‐3157.


Advanced Practice (Grenon) 1

Self-care Support for Patients with Gastrointestinal Cancer:

iCancerHealth PromotingNina Grenon, DNP, AOCN

Adult Geriatric Nurse PractitionerDana-Farber Cancer Institute

Disclosures

• “No commercial or financial interest to disclose”

Our Team

• Co-Investigators– Nadine J. McCleary, MD, MPH – Nina Grenon, DNP

• Principal Investigator – Donna L. Berry, PhD, RN,

FAAN, AOCN

• Statistician – Traci Blonquist, MS

• Project Director – Manan Nayak, MA

• Research Staff– Tha’er Momani, PhD, RN

• Partial funding– Medocity, Inc.



What’s Been Done Before?• Standardized symptom and quality of life (SxQOL)

assessments/interventions have been developed and used widely in research studies to measure outcomes of treatments and interventions

• Clinical benefits– Increase the depth and breadth of discussions of SxQOL and patient-reported

emotional well-being during clinic visits– Increase treatment of psychosocial issues and symptoms– Reduce cancer symptom distress when combined with self care patient

education and monitoring. – Lengthen survival in advanced stage patients

Technology

• Patient-centered technologies have been developed and tested for both point of service and remote (home) use– Computers– Tablets– Smart phones

What Do We Want to Learn?• Can we add a direct patient-to-clinician messaging component?• Which features of such a program are utilized remotely most

often?• How often will patients use it?• What do patients and clinicians think about it?



Participants• Eligible patient participants were seen in gastrointestinal (GI)

oncology clinic

− 18 years or older− Any stage malignant

gastrointestinal disease− Receiving or planning therapy

with the GI oncology service

− Speak and read English − Remote access via either a

personal computer web browser, iOS device (smart phone or tablet), or Android (phone only)

Participants, cont. • Patients were excluded from enrollment if they had a

documented diagnosis of a psychiatric depressive or cognitive impairment

• Eligible clinician participants – Nurses, physicians or physician assistants– Performed consults/exams in the GI oncology clinic

• IRB approved minimal risk study

Study Design

• Design: Single arm, pilot study

• The purpose of the study was to explore implementation, feasibility and impact of the iCancerHealth® intervention



Study Procedures• Participants engaged with the iCancerHealth® application (app)

at home • All participants registered and used the platform to complete the

symptom assessment in clinic at baseline, either on a personal device or on a study iPad

• From home, participants reported symptoms, received management information tailored to level of symptom severity and communications from clinicians as needed

Study Procedures, cont.• Clinicians received alerts and communication through the

provider side (Medocity MD®) of the application• Participants were called weekly, or met in person during a

regular clinic visit, and reminded to use the app and finally, to perform a last symptom report 4-6 weeks after enrollment

iCancerHealth® Landing Page



iCancerHealth® Symptom Display Selector

Planned Outcome Evaluation• A total of 70 patient participants were planned and a 15% attrition rate was

expected. With 60 evaluable patient participants and complete T1-T2 data, the 95% Confidence Interval (CI) was planned to be no wider than 26%.

• With 60 evaluable participants, we needed to observe 13 accessing iCancerHealth to have the upper bound of the 95% CI covering 34% (previous study unprompted access rate). Therefore, iCancerHealth will be considered feasible if at least an 80% enrollment rate is observed and at least 13 of 60 patients remotely access the tool.

Results• A total of 64 patients were approached to participate in the

study, of which 57 enrolled.• Two participants withdrew on the day of the final T2, declining

the final symptom assessment and acceptability survey. Of the remaining 55, four participants chose not to respond to the final survey, stating they had not used the app sufficiently at home to answer the acceptability survey.



Participant DemographicsN %

Age in years

> 60 29 50.88

Gender

Male 33 57.89

Race

White 50 87.72

Working

Yes 30 52.63

Married/Partnered

Yes 40 70.18

Education

Some college or higher 52 91.23

Technology Use DemographicsN %

Computer use

Sometimes 6 10.53

Often 12 21.05

Very often 39 68.42

Smartphone use

Never 6 10.53

Rarely 1 1.75

Sometimes 6 10.53

Often 5 8.77

Very often 39 68.42

Ever downloaded a health app?

No 27 47.37

Yes 30 52.63

Results, cont. • If a participant entered at least 1 module (calendar, community,

dashboard, health tracker, medical diary, inbox, medications, profile, nutrition, scrapbook, or settings), then that access was considered remote use

• 53 (93%; 95% exact CI 85-99%) accessed at least 1 feature, at least once



Results, cont.• Favorite feature of the application?

– Patient-clinician communication function (n=10)

– Symptom tracking function (n=9) – Daily medication reminder (n=5) – Information about side effects (n=2) – Medical diary (n=2)– Monitor trends (n=2)– Pill box (n=1)– Community forum (n=1)

ModuleOverall

N %

Calendar 7 12

Community 25 44

Dashboard 24 42

Symptom Tracker 49 86

Medical Diary 18 32

My Inbox 36 63

My Medications 34 60

My Profile 30 53

Nutrition 26 46

Scrapbook 23 40

Settings 8 14

Acceptability Details

High AcceptabilityTotal+

Version

Version 1 Version 2

N %* N %* N %*

Easy 45 88 35 87 8 89

Understandable 48 94 38 95 8 89

Enjoy 29 58 21 54 7 78

Helpful 23 46 16 41 6 67

Amount of time 45 88 34 85 9 100

Satisfaction 34 67 25 62 7 78*Percentage of those answering these items+Includes those participants who used both version 1 and 2 and both

The proportion of 51 participants indicating >4 on core acceptability items at T2

Was This Acceptable?Patient Participants• The overall median E-

acceptability scale score (easy, understandable, enjoy, helpful, amount of time, and satisfaction) was 25.5 (range 12-30; maximum possible 30)

Clinician Participants• All clinicians accessed the following features at

least once after enrollment and orientation: community, dashboard, inbox, medication and health alerts, my inbox, my profile, and participant dashboard

• Two of the three clinicians accessed: participant record, settings, and symptom management

• One of the clinicians viewed the medical diary



Clinician Comments

• Ease of use, visuals easy to understand• Direct emails were helpful at expanding care• Requires integration in EMR

Study Limitations

• Single arm study• Limited to one disease center (gastrointestinal cancer

center)• Small sample of providers

Conclusion

In a sample of patients actively undergoing treatment for gastrointestinal cancer, and who had Internet access on a personal device, we found a high percentage of remote users and adequate acceptability with the iCancerHealth® application. Our criteria for patient participant success in this pilot study were met. Clinician users were satisfied with most aspects of the app.



Key Takeaways

• The technology is feasible, it can educate patients to become more confident and empower self management of symptoms.

• The technology needs to be embedded within specific electronic medical records.

• The technology needs testing in the elderly and other high risk population

References Berry DL, Hong F, Halpenny B, et al. The electronic self report assessment and intervention for cancer:

promoting patient verbal reporting of symptom and quality of life issues in a randomized controlled trial. BMC cancer. 2014;14(1):513.

Berry DL, Hong F, Halpenny B, et al. Electronic Self-Report Assessment for Cancer and Self-Care Support: Results of a Multicenter Randomized Trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2014;32:199-205.

Halfdanarson TR, Jatoi A. Oral cancer chemotherapy: the critical interplay between patient education and patient safety. Curr Oncol Rep. 2010;12(4):247-252.

American-College-of-Surgeons. Cancer Program Standards 2012: Ensuring Patient-Centered Care. Vol 1.1. Chicago, IL: American College of Surgeons; 2012: http://www.facs.org/cancer/coc/

Roter DL, Hall JA. Physician gender and patient-centered communication: a critical review of empirical research. Annu Rev Public Health. 2004;25:497-519.

Surbone A. Cultural aspects of communication in cancer care. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2008;16(3):235-240.

References, cont. Ong LM, de Haes JC, Hoos AM, Lammes FB. Doctor-patient communication: a review of the literature. Soc Sci

Med. 1995;40(7):903-918. Kinnersley P, Edwards A, Hood K, et al. Interventions before consultations for helping patients address their

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