1. Breast Cancer Rehabilitation A Case Study in Prospective Surveillance
Nicole L. Stout MPT, CLT-LANA Kaiser Permanente Rockville, Maryland

2. Inherent in cancer treatment…
Known sequelae that have a deleterious impact on function, impacting a majority of patients
An aggregate burden of impairment
Short and long term impact on function
Risk for impairment and recurrent disease
Low risk today ≠ Low risk tomorrow
Patients want and need information to help them stay functional and active

3. Inherent in cancer treatment
Economic burden of cancer morbidity
World-wide cancer morbidity creates the largest economic burden on society
**This does NOT include the cost of treating cancer
20% > heart disease
Greater than morbidity with HIV/AIDS and TB
ACS and LAF The Global Economic Cost of Cancer. Presented at UICC Cancer Congress

4. Why prospective surveillance?
Cancer treatment causes functional deficits
Physical therapists are experts in movement and function and have reliable and valid tools to detect and treat many cancer-related impairments
Surveillance enables early detection of and intervention for treatment-related impairments
Surveillance and intervention will decrease severity or prevent impairment and functional loss at all stages of disease management

5. Is it effective? YES!
Stout, NL. Pfalzer, L. Springer, B. Levy, E. McGarvey, C. Danoff, J. Gerber, L. Soballe, P. Breast Cancer Related Lymphedema: Comparing a Prospective Surveillance Model to A Traditional Model of Care. Phys Ther
Stout NL, Pfalzer L, Levy E, McGarvey C, Springer B, Gerber L, Soballe P. Segmental Limb Volume Changes as a Predictor of the Onset of Lymphedema in Women with Early Breast Cancer. PM&R 2011. 
Morehead-Gee A, Pfalzer L, Levy E, McGarvey C, Springer B, Soballe P, Gerber L, Stout N. Racial disparities in physical and functional domains in women with early breast cancer
Springer, B. Levy, E. McGarvey, C. Pfalzer, L. Stout, NL. Gerber, L. Soballe, P. Danoff J. Pre-operative Assessment Enables Early Diagnosis and Recovery of Shoulder Function in Patients with Breast Cancer. Br Ca Res & Treat
Gerber, L. Stout, NL. McGarvey, C. Soballe, P. Shieh, C. Diao, G. Springer, B. Pfalzer, L. Clinically Significant Fatigue in Women with Primary Breast Cancer. Support Care Cancer
Stout Gergich, N. Pfalzer, L. McGarvey, C. Springer, B. Gerber, L. Soballe, P. Pre-operative assessment enables early diagnosis and successful treatment of lymphedema. Cancer

6. A Vision for Prospective Surveillance
“The only thing worse than being blind is having sight but having no vision.” - Helen Keller What if we could promote an evidence-based standard of care that improves the quality of life for cancer survivors by reducing the potential for functional decline that is known to be associated with disease treatment?

7. Stout, Binkley, Schmitz et al. Cancer 2012

8. Clinical Diagnostic Standardization
Pre-operative assessment and prospective surveillance
Subjective assessment
Reliable and valid tools
Sensitive diagnostic threshold
Without each of these, we introduce error

9. Pre-operative Assessment Establishing the Baseline
Strength
ROM
Physical, Recreational and Social activity levels
Inter-limb volume measurement
Weight consideration increases/decreases over time
Normal limb variance – 3% to 10% in normal healthy individuals Gebruers 2007
Weight
Prior history of trauma or surgery
Comorbid conditions

10. Ongoing Surveillance Regular intervals of post-op follow-up
enable early identification of LE and other physical impairments (Balzarini 2006, Albert 2010, Springer 2010)
Interval follow-up should continue for 1st post-op year, or longer
Progression of lymphedema can occur at any time post treatment (Armer 2010, Johansson 2011, Bar Ad 2009)
We recommend pre-operative assessment with post-operative follow-up, using standardized measurement techniques, as the most effective means to diagnose sub-clinical LE.
Pre-operative assessment is vital to a surveillance protocol as it identifies normal inter-limb variance allowing for an accurate assessment of post-operative volume changes consistent with LE.
Regular intervals of post-op follow-up enable early identification of LE and other physical impairments resulting from BC related treatment67.
Interval follow-up should continue for the first post-op year, or longer as the average time to onset of BC-LE is within 3 years of the initial treatment.68

11. Cochran Systematic Review McNeeley et al. 2010
24 studies involving 2132 participants
10 studies examined the effect of early versus delayed implementation of post operative upper-limb exercise
14 studies examined the effect of structured upper-limb exercise compared to usual care/comparison
Synopsis of findings
PT based exercise results in a significant and clinically meaningful improvement in shoulder ROM and restoration of strength after breast cancer treatment
There was no evidence of increased risk of lymphedema from exercise at any time point

12. Post operative exercises
Upper –limb exercise (shoulder ROM and stretching) is helpful in recovering upper-limb movement following BC surgery
Starting exercise day 1 to day 3 post op may result in better shoulder movement (WMD: 10.6 degrees ; 95 % CI: 4.51 to 16.6) however there is no long term detriment to ROM if exercise is started more than 7 days post op.
Early exercise results in more wound drainage (SMD: 0.31; 95 % CI: 0.14 to 0.49) and requires drains to be in place longer (WMD: 1.15 days; 95% CI: 0.65 to 1.65) than if exercise is delayed by 1 week

13. Post operative exercises
Upper limb exercises provided post operatively
resulted in better outcomes at 1 year
Shoulder flexion ROM at two weeks (MD: degrees; 95% CI: 0.69 to 25.16) and at one year (MD: 5.40 degrees; 95% CI: 1.13 to 9.67)
Shoulder abduction ROM at two weeks (MD: 9.72 degrees; 95% CI: to 28.06) at one month (MD:22.05 degrees; 95% CI: 0.97 to 43.13) and at one year (MD: 7.00 degrees; 95% CI: 1.30 to 12.70)

14. Adjuvant therapy and exercise
Adjuvant cancer treatment: Upper limb exercise program versus comparison
Exercise programs may benefit*:
Shoulder abduction (MD: 11 degrees; 95% CI: 2.38 to 19.62)
Upper-extremity strength through resistance exercise (MD: 7.30 kg; 95% CI: 4.42 to 10.18).
*These findings are from single studies.

15. Risk Factor Profile Treatment-related Lifestyle (modifiable)
Extent of surgery/LN dissection Clark 2005, Paskett 2007, Swenson 2009
Radiation therapy Paskett 2007, Swenson 2009
Chemotherapy Paskett 2007, Swenson 2009
Seroma Swenson 2009
Lifestyle (modifiable)
Having a BMI >25 (or increasing BMI >25) Soran 2006, Clark 2005, Paskett 2007, Swenson 2009
Having an infection in the affected arm Soran 2006,
Skin puncture to the affected arm Clark 2005,

16. Early Clinical Presentation
Patient’s subjective reports
Armer et al 2003 Nurs Research
Sequential limb volume measurements, identifying segmental changes in volume
Early post operative shoulder ROM < 80 degrees ER
Prior surgery or trauma to the UE
Stout et al 2011 PM&R
Stout et al 2012 PMR
Springer et al 2010 Br Ca Res and Treat

17. Breast Cancer Diagnosis
Post Operative Surveillance- 3 month interval follow-up
< 3 % change from pre-operative
> 3 % change from pre-operative
Sleeve and Gauntlet
4 weeks daily wear
Breast Cancer Diagnosis
Physical Therapy
Surgery
Med. Onc.
Rad. Onc.
Pre-Operative Multi-Disciplinary Staging and Plan of Care
Reassess Limb Volume
Resume 3 month follow-up surveillance program
Volume decrease
Volume Increase
Initiate Decongestive Therapy
Stout et al Cancer 2008

18. 1 year lymphedema rates Citation Reported Incidence Intervention
Stout et al 2008
21% Sub-clinical
0 % Stage I
2 % Stage II*
0 % Stage III
Education and Surveillance Monitoring with intervention upon volume change
Hayes et al
33 % Stage II/III
None
Armer et al
48 % Stage II/III
Bar Ad et al
16 % Stage I with 21 % progression rate to Stage II in 1st year
Torres Lacomba 2010
7 % Stage I
Manual lymph drainage, education and surveillance
* Associated with infection (n = 2) or metastatic disease (n = 2)

19. 1 year shoulder morbidity rates
Citation
Reported Incidence
Intervention
Springer et al (2010) 4%
Prospective surveillance and education. PT if impairment detected
Yang et al (2010)
24 %
None
Devoogdt et al (2009)
45 %
Post op 1 visit only and ongoing education
Nesvold et al (2008)
12 % - 47 % (SLNB – ALND)
Education for post op exercises
Box et al (2002)
Education only

20. Direct Cost Analysis of PSM
Prospective Surveillance Model
$636.19
Traditional Model $
Stout et al PTJ 2012

21. Case Study 42 year old woman diagnosed with Stage IIA L BC
Eastern Cooperative Oncology Group status: 0
Physical Activity level:
exercises 3-4 times/week including; yoga, weight lifting, running and swimming
golf and hiking recreationally
Social activities; book club, church activities
Employment status: full time clinical research nurse , no significant lifting, carrying or physical exertion.
Right handed
No prior trauma or surgery to the shoulders, elbow wrist/hand, nor neck injuries

22. Pre Operative Assessment
How does the evidence guide you in this intervention?
Objective measures?
Outcomes tools?
Patient education?
Post operative follow up?

23. Case Study Immediate post op
Presents to PT post operative day 3 s/p L modified radical mastectomy (MRM) with a sentinel lymph node biopsy (SLNB)
A Jackson Pratt (JP) drain is in place, putting out >100 cc’s of fluid/day
Pain at rest = 4/10 She is hesitant and fearful with movement
Pain with reaching at shoulder level = 6/10 and is described as “pulling in the chest wall”

24. Case Study Immediate post op
RED flags?
What is your plan for today?

25. Case Study 10 days post op
Returns to PT 10 days post op. The JP drain has been removed, she starts chemotherapy in 2 weeks
She has been trying to move her arms to attempt routine daily activities however has pain with overhead reaching rated at 3/10.
Examination reveals ROM deficits of the LUE at 130 degrees overhead and a pulling sensation from her axilla
Limb volume is not significantly different based on her pre-operative measurement with consideration for her contralateral limb.

26. Case Study 10 days post op Impairments present?
Can she start back to yoga yet?
Exercise program today?
Outcomes measures?
Education points?

27. Case Study 3 months post op
Returns to PT 3 months post op, completed 4 cycles of Adrimycin and Cytoxan and starts Taxol this week
Completing HEP and ADL’s, but still c/o slight limitation in UE use overhead
Working part time, mostly from home
Doing yoga on off-chemo weeks, has not played a round of golf. At the driving range she notices her left arm is weak
Fatigue 5-6/10 on most days following chemo, 3-4/10 in her off-chemo-weeks
Limb volume increase of 5.7% is measured but barely visible . She notes the arm is heavy but 0/10 pain.

28. Case Study 3 months post op
Assessment reveals:
Abnormal movement pattern LUE when reaching overhead: notable upper trap overuse
Gross UE strength 4+/5
Serratus anterior 3+/5,
Middle and Lower trap 4-/5
L UE resting position: protracted with slight internal rotation at the GH joint

29. Case Study 3 months post op
What if we do nothing here?
What if this patient was not on a prospective surveillance program?

30. Case Study 6 Months post op
At 6 months post op she returns for a PT reexamination. Completed radiation therapy 3 days ago.
Has been consistent with her UE HEP, however has not continued her aerobic ex program due to fatigue (5/10)
Complains of “tightness” in her left chest wall, and restrictions with overhead activities and various yoga postures

31. Case Study 6 months post op
Radiation-related skin changes noted
LUE limb volume is stable with no evidence of lymphedema
AROM of the left UE is 165 degrees overhead and she notes right chest wall pain at 4/10, mostly with far overhead reaching
Scapular recruitment is symmetrical. No strength deficits noted

32. Case Study 6 Months post op
What effect will radiation therapy have on the tissue? How will it impact our exercise recommendations?
Recommendations for improved adherence to exercise program?
Education points?

33. Case Study
Ongoing surveillance visits are conducted at 9 months, 12 months and then at 6 month intervals

34. Implications for Practice
We rely on an impairment-based model for dx. and Rx. of treatment related impairments.
This paradigm is inadequate if for early detection and remediation of common cancer-related impairments.
A shift in the current practice pattern in favor of a surveillance model is necessary and indicated based on the results presented here.
In the absence of a surveillance program, the earliest dx. of impairments will be delayed and promotes late disability from BC treatment
Pre-operative baseline measurement is vital to successfully diagnosing sub-clinical LE. However, currently, physical therapists in clinical practice rely on an impairment-based model for diagnosing and treating LE. This paradigm is inadequate if a sub-clinical diagnosis is to be made. A shift in the current practice pattern in favor of a surveillance model is necessary and indicated based on the results presented here. In the absence of a surveillance program, the earliest diagnosis of LE will be missed.

35. More on Prospective Surveillance
APTA Video series on Emerging Models of Care
American Cancer Society – Supplement to Cancer April 15, 2012 “A Prospective Surveillance Model for Rehabilitation for Women with Breast Cancer.”