Implementation of the Dance Head and Neck Clinical Pathway

Transcription

1 Implementation of the Dance Head and Neck Clinical Pathway Barbara Messing, MA, CCC-SLP, BCS-S, FASHA & Head and Neck Team GBMC Head and Neck Grand Rounds

2 Acknowledgements

3 Acknowledgements

4 Background Evidence supporting prophylactic swallowing exercises for patients with head & neck cancer (HNC) is inconsistent. Positive results (Carnaby-Mann et al. 2012; Carroll et al. 2008; Duarte et al. 2013; Hutcheson et al. 2013; Kotz et al. 2012; Kulbersh et al. 2006; van der Molen et al 2011; van der Molen et al. 2014) Few changes (Mortensen et al. 2015) Issues with studies Retrospective studies, small cohorts Randomized controlled trials underpowered Inconsistent exercise protocols Variable positive effects different time points

5 The value of interventions Increased awareness of the importance of early supportive care for dysphagia management. Recent literature confirms that access to services and management of dysphagia during and post treatment continues to be an issue for patients nationally and internationally. Logeman et al 1997, Krisciunas et al 2012, Roe & Ashforth 2011, Wall et al 2013,

6 RCT: AIMS Primary aim was to determine if patients who adhered to an intensive prophylactic swallow exercise protocol would have better oral intake as measured by the FOIS rating scale (Crary, 2005). Secondary aim: was to determine if participants in the exercise group would report better quality of life as measured on EORTC QOL scales. compared to control group

7 Study Design Randomized Controlled Trial 2013 (closed to recruitment) Exercise Group vs. Control Group Powered: 30pts /group based on FOIS at 3 months Study timepoints: Baseline, [1, 2 months-exercise group only], 3, 6, 12, 24 months Inclusion criteria Individuals over age 21 diagnosed Staging (Stage III & IV) Biopsy Proven Squamous Cell Carcinoma Site of Lesion: Head and Neck

8 GBMC's Organ Preservation Treatment Stage III-IV Cancer Hyperfractionated radiation therapy 5 days per week for 6-7 weeks, 1 week break mid-tx. Radiation therapy was delivered at the following doses: 7,000 cgy to primary site 6,000 cgy to involved neck 5,000 cgy to uninvolved neck and supraclavicular nodes At the 4,000 cgy point there is a 1 week treatment break. Concurrent chemotherapy Cisplatin or 5-fu and cisplatin Neck dissection 8-12 weeks post CXRT. - N2 (or greater) neck disease Prophylactic PEG placement prior to treatment all patients

9 Primary Outcome Variable Functional Oral Intake Scale (FOIS) (Crary, 2005) Analyzed using a binary classification functional / normal diet dysphagic

10 Secondary Outcome Variables Modified Barium Swallow (MBS) [pre & 3 months post only] Features of Swallowing and Dysphagia (FOSAD) Oral-pharyngeal swallow efficiency (OPSE) Penetration-Aspiration Scale (PAS) Dysphagia Outcome and Severity Scale (DOSS)

11 Secondary Outcome Variables Rating of Oral Motor Skills (ROMS) Oropharyngeal strength and range of motion Incisal opening Oral Cavity Assessment (OCA) NCI Common Toxicity Criteria, Version 3.0 (CTCAE) Common Terminology Criteria for Adverse Events (CTCAE) Clinical exam (C/E) & Function/symptom (F/S) mucositis scales Quality of Life: EORTC QLQ-C30 general quality of life QLQ-H&N35 Head and Neck cancer quality of life module

12 Adherence Patient s completed an exercise checklist journal during treatment and up to 3 months post treatment. Adherence monitored: participants recorded: # of days per week exercises were completed Total # of exercise sets performed Speech Pathologists collected, review and checked exercise journals

13 Exercise Group Protocol Exercise protocol: baseline, weekly during CXRT, 1, 2, 3 up to 24 months Oropharyngeal strength/stretch exercises and swallow maneuvers. Completed twice daily, 7 days per week during CXRT (exception CXRT break week in week 4) and up to 3 months post. Home practice: daily practice of swallow exercises and therabite TheraBite exercise (daily) Swallow therapy frequency to ensure adherence During CXRT: weekly swallow therapy session Baseline, weekly during CXRT, 1, 2 and again at 3 months

14 Control Group Baseline & reassessment times only (baseline, 3, 6, 12 & 24 months) TheraBite prophylactically as per institution standard of care. Exceptions to protocol 4 referred for dysphagia management 3 months post CXRT -average 2.75 therapy sessions

15 Results

16 Figure 1. Consort Chart Assessed for eligibility (n = 135) Enrollment Excluded Declined or missed study participation (n = 75) Accrued and randomized (n = 60) Allocation Allocated to control group (n = 30) Received no intervention [therabite only] (n = 30) Allocated to exercise group (n = 30) Instructed on swallow exercise protocol and therabite (n = 30) Lost to follow-up after randomization (n = 1) Patient deceased (n = 1) Baseline Lost to follow-up (n = 1) Patient deceased (n = 1) During CXRT Lost to follow-up (n = 1) Patient recurred (n = 1) Lost to follow-up (n = 9) 6 months (n = 1) Patient recurred (n = 1) 12 months (n = 2) Patient withdrew (n = 1) Patient recurred (n = 1) 24 months (n = 6) Patient withdrew (n = 4) Patient recurred (n = 1) Patient deceased (n = 1) Follow-Up Lost to follow-up (n = 7) 3 months (n = 3) Patient withdrew (n = 1) Patient recurred (n = 1) Metastasis (n = 1) 12 months (n = 1) Patient deceased (n = 1) 24 months (n = 3) Patient withdrew (n = 3)

17 Table 1: Demographics Demographics Characteristics Control N=30 Exercise N=30 p-value Age at enrollment median(range) 58(39, 79) 55(44, 78) Gender: Male, N(%) 26(86.7%) 28(93.3%) Weight at enrollment median(range) 190(116, 315) 196(144, 330) 0.63 Alcohol use, N(%) 18(60%) 23(82.1%) Tobacco use, N(%) 17(56.7%) 13(44.8%) Stricture, N(%) 3(10%) 6(20%) Web, N(%) 3(10%) 4(13.3%) 1 Stricture or Web, N(%) 6(20%) 10(33.3%) 0.382

18 Tumor Characteristics Characteristics Control N=30 Exercise N=30 p-value Tumor location, N(%) Larynx 2(6.7%) 4(13.3%) Supraglottis 1 3 Glottic 1 1 Pharynx 28(93.3%) 26(86.7%) Oropharynx Hypopharynx 2 2 Both 1 0 T stage (16.7%) 4(13.3%) 2 13(43.3%) 11(36.7%) 3 10(33.3%) 12(40%) 4 2(6.7%) 3(10%) Nodes, N(%) 27(90%) 22(73.3%) 0.181

19 Primary Outcome Variable: FOIS % of worse outcome Timepoint Control Group FOIS 1-5 Exercise Group FOIS 1-5 Significance Pre-treatment 10% 0% months 60% 50% months 33% 27% months 4% 12% months

20 Secondary Variables Table 2. Analysis 1 of Clinician and Patient Reported Outcomes across time points Parameter Pre-treatment 3 months post CXRT 6 months post CXRT 12 months post CXRT 24 months post CXRT Control vs. Exercise p- value Control vs. Exercise p- value Control vs. Exercise p- value Control vs. Exercise p- value Control vs. Exercise p- value Oromotor and toxicities Oromotor 16%; 13% %; 9% %; 5% %; 8% %; 9% 0.88 assessment 4 Incisal opening 46.4(9.5); 50.7(5.9) (8.4); 43.2(8.5) (7.3); 43.9(8.5) (7.0); 46.7(7.4) (6.3); 48.6(8.8) 0.04 OCA 5 32%; 43% %; 7% %; 5% %; 4% %; 14% 0.72 CTCAE/CE 6 0%; 4% - 68%; 93% %; 42% %; 16% %; 10% - CTCAE/FS 7 0%; 7% - 58%; 86% %; 37% %; 4% %; 10% - Pain 8 70%; 76% %; 46% %; 43% %; 33% %; 33% 1.0 Weight (pounds) 195(42); 203(44) (35); 174(20) (31); 167(24) (33); 177(25) (33); 180(27) 0.56

21 Swallow physiology Table 3. Analysis of swallow physiology at baseline and 3 months Parameter MBS Baseline 3 months post CXRT Control Exercise p-value Control Exercise p-value Dysphagia Outcome Severity 11% 7% % 40% 0.29 Scale OPSE OTT (seconds) 18% 11% % 15% 0.62 OPSE PTT (seconds) 29% 14% % 20% 0.08 OPSE % bolus swallowed 43% 25% % 20% 0.05 OPSE total score 29% 11% % 15% 0.04 Oral phase impairments 25% 10% % 10% 0.13 Pharyngeal phase impairments 61% 41% % 42% Esophageal phase impairments 56% 38% % 47% 0.87 PAS Penetration % 10% % 21% 0.33 PAS Aspiration 6-8 7% 7% 1.0 9% 0% 0.49

22 Figure 2: Status of PEG tube p = 0.17 Not sig. Duration PEG tube was in place. Not duration of PEG use.

23 Quality of life outcomes Parameter Pre-treatment 3 months post CXRT Control vs. Exercise p- value Control vs. Exercise p- value 6 months post CXRT Control vs. Exercise p- value 12 months post CXRT Control vs. Exercise p- value 24 months post CXRT Control vs. Exercise p- value QOL: EORTC 9 QLQ-C30 function 77.9(18.1); 76.3(16.5) (18.6); 85.2(12.8) (13.4); 82.1(22.7) (10.7); 89.3(15.7) (5.4); 92.3(9.9) 0.75 global health 73.9(17.6); 71.0(15.0) (17.4); 84.0(10.9) (15.9); 77.8(22.4) (13.5); 80.3(17.4) (13.7); 88.4(12.8) 0.98 symptom 18.8(14.5); 21.0(12.1) (11.9); 14.0(14.2) (10.5); 13.4(13.0) (9.7); 10.1(12.5) (6.7); 8.5(7.6) 0.97 QLQ-H&N (16.7); 15.1(9.0) (10.5); 23.2(14.0) (12.0); 17.8(11.3) (8.5); 17.5(16.0) (7.6); 14.4(10.7) 0.33 HN Swallowing 23.7(33.7); 11.1(13.5) (17.8); 16.0(22.3) (17.1); 18.9(23.6) (13.0); 12.3(22.6) (7.5); 11.1(12.1) 0.65 HN Social eating 17.9(27.0); 6.7(10.1) (23.2); 11.4(11.3) (15.9); 23.0(30.2) (11.1); 18.3(25.9) (6.8); 12.0(18.8) 0.13

24 Adherence Data available for 66% of cohort No participant was fully adherent to maximum treatment dose Good adherence. influenced by week of CXRT Week 2: 56% practicing every day, 100% 4 times/week Ave 64% of exercises completed Week 5: 41% practicing every day, 53% 4 times/week Ave 30% of exercises completed (26% week 6; 17 % week 7)

25 RCT Summary Some evidence for positive early effects Swallow physiology better in the exercise group at various time points. Oromotor function OPSE % bolus swallowed OPSE total score Pharyngeal phase impairments Trend for shorter pharyngeal transit times

26 RCT Summary Some positive early effects The current study failed to demonstrate any substantial or sustained benefits. Future: Implement new assessment and therapy approaches. Further research studies designed to examine appropriate prophylactic swallowing exercises implemented with adequate frequency, intensity and long-term practice for maximum functional gain and recovery. Standardized type, intensity & duration of swallow exercise protocols.

27 Messing, B. P., Ward, E. C., Lazarus, C. L., Kim, M., Zhou, X., Silinonte, J.,... & Neuner, G. (2017). Prophylactic Swallow Therapy for Patients with Head and Neck Cancer Undergoing Chemoradiotherapy: A Randomized Trial. Dysphagia, 1-14.

28 Driving the RCT Swallow Study forward into Clinical Practice: Dance Head and Neck Clinical Pathway D-HNCP

29 Translating evidence into a head & neck multidisciplinary clinical pathway The D-HNCP was implemented at the Milton J Dance in 2011 All HNC patients receive regular MDT appointments pretreatment, during treatment and up to 24 months post treatment in the D-HNCP. Within the pathway, routine Clinical Reported Outcomes (CROs) & Patient Reported Outcomes (PROs) are collected to monitor outcomes. Evolution of the D-HNCP is ongoing and involves team interaction, coordination of care, and the ability to tolerate changes in response to system changes

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31 Multidisciplinary Team (MDT) Services Delivery of multidisciplinary team (MDT) services through a coordinated head and neck clinical pathway (HNCP) maximize results increase efficiency in care delivery reduce costs shorten the length of hospital stay improve overall patient outcomes 1,2,

32 Multidisciplinary Team (MDT) Services Implementing a clinical pathway in today s complex healthcare environment is fraught with roadblocks and pitfalls.

33 Multidisciplinary team: Identify Key Stakeholders Systems Analyst Clinical Research Coordinator Nurses Oncology Dietitians Administrative Staff Patient and family Referring Physician What it takes to make it happen: planning, evidence based protocols and support from all team members, most especially the patient and family members. HN oncology physicians Plastic Surgery Radiation oncologists Medical oncologists Dentist Maxillofacial Oncology social workers Speech-language pathologists

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35 Data Collection

36 V: Compensatory swallow strategy: i.e, Super Supraglottic swallow, as indicated. Postural changes, as indicated: Diet modifications, as indicated: Other compensatory strategies: Nutritional supplements:

37 Adherence

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39 Gaps & Barriers to Service Delivery Under utilization of rehabilitation services multifactorial Failure to refer Financial and insurance issues Patient factors Identify team leads Identify champions Advocate for your patients and profession

40 DISCUSSION/CONCLUSION o Keep patients needs primary focus. o Evidence quality, networks/communication, culture, and implementation climate were constructs identified as facilitators. o Barriers are the complex nature of the pathway & impact on staff. o Core elements included identifying champions for patient navigation to ensure patient follow up, maintaining and sustaining o Consistency & stability of patient tracking and data collection (electronic data capturing systems) using a well-designed platform. o Patient attendance at all appointments was high both years with low rates of non-compliance. o PRO/CRO reporting improved between 2013 to 2014, however, requires further improvement, particularly at 3, 6 & 12 months.overall, the complexity of designing, implementing and sustaining a Clinical Pathway for HNC patients using a systematic approach is essential. o Long term follow of HNC patients proves to be challenging. It is important to consider reasons for adherence rate changes post treatment and adjust, modify, plan.

41 Thank you