Kathryn Schmitz, PhD, MPH Assistant Professor, Principal Investigator  Division of Clinical Epidemiology Center for Clin

Kathryn Schmitz, PhD, MPH Assistant Professor, Principal Investigator Division of Clinical Epidemiology Center for Clin PowerPoint PPT Presentation


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Overview. PAL studyBackgroundStudy OverviewBaseline characteristicsMain ResultsDevelopment of BIRSBIRS Results (Speck)Time for questions. Epidemiology of ARM Lymphedema after BrCa. 200-400,000 of the approximately 2 million BrCa survivors in the US have clinically diagnosed lymphedema (Stolberg 1998)The prevalence is estimated at 49% when including self-reported symptoms of lymphedema (Petrek 2000) Incidence varies by studyAs low as 6% after SLNBRecent publication with objective mea9441

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Kathryn Schmitz, PhD, MPH Assistant Professor, Principal Investigator Division of Clinical Epidemiology Center for Clin

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1. Kathryn Schmitz, PhD, MPH Assistant Professor, Principal Investigator Division of Clinical Epidemiology Center for Clinical Epidemiology and Biostatistics University of Pennsylvania School of Medicine Presentation of Main Results

2. Overview PAL study Background Study Overview Baseline characteristics Main Results Development of BIRS BIRS Results (Speck) Time for questions

4. Risk factors for lymphedema secondary to cancer Not well-described: Data from 20-year prospective cohort study of 272 BrCa survivors found: Significantly associated: Arm infection, injury and elevated BMI Not associated: Occupational and leisure-time physical activity (light, moderate and vigorous) 20-year prospective cohort study of 272 women treated with mastectomy and complete axillary dissection (Petrek 2001)20-year prospective cohort study of 272 women treated with mastectomy and complete axillary dissection (Petrek 2001)

5. Issue: Survivors are at increased risk for chronic disease and morbidity: osteoporosis, heart disease, and recurrence Exercise may help women: regain strength, function, and range of motion after surgery with re-empowerment & body image ? quality of life after a cancer diagnosis Decrease risk of chronic disease

6. However… Current clinical guidelines warn breast cancer survivors against vigorous, repetitive, or excessive upper body exercise for fear of increasing risk for lymphedema (Harris 2000) NLN, ACS, Komen, NCI guidelines – All restrict upper body activity in women at risk for lymphedema

7. Rationale These guidelines are problematic: Survivors are limited in activities and rehabilitation Cannot attain the health benefits of physical activity There is physiological evidence that exercise may improve lymph flow and resorption

8. To date… Prior interventions have examined the effects of upper body exercise on lymphedema in BrCa survivors Competitive dragon-boat racing Upper body aerobic/strength training No increase in incident lymphedema or increased symptoms in women with or at risk for lymphedema These studies have been limited by methodology Case-series Uncontrolled pre-post designs Small randomized trials A group of 20 survivors in British Columbia participated in competitive dragon-boat racing for almost a year – no change in circumference measurements pre-postA group of 20 survivors in British Columbia participated in competitive dragon-boat racing for almost a year – no change in circumference measurements pre-post

9. Based on these findings: Supervised slowly progressive controlled increase in physiological stress through strength training may be more beneficial to BrCa survivors vs. acute stress from activities of daily living Analogy Heart attack and shoveling snow Lymphedema and lifting a heavy object

10. The Physical Activity and Lymphedema (PAL) Trial R01-CA106851 1 year randomized controlled intervention Twice weekly progressive strength training Non-exercising control Recruitment goal = 288 BrCa survivors Measurements at baseline, 3, 6, 9 and 12 months 1/2 with, 1/2 without lymphedema at baseline 1-15 years post-diagnosis

11. PAL Design Go through this slide slowly PAL trial is a 1 year randomized controlled intervention. The target # of participants was 288 & was split between those who conducted twice weekly progressive strength training for 12 months (N=144) & Non-exercising control (N=144) Explain breakdown split b/w LYMPH group (1-15 yrs post diagnosis) and NO LYMPH (at risk) group (1-5 yrs post dx) Go through this slide slowly PAL trial is a 1 year randomized controlled intervention. The target # of participants was 288 & was split between those who conducted twice weekly progressive strength training for 12 months (N=144) & Non-exercising control (N=144) Explain breakdown split b/w LYMPH group (1-15 yrs post diagnosis) and NO LYMPH (at risk) group (1-5 yrs post dx)

12. Demographics In the orange we have demo data on those w/lypmph etc. If you scale down you see remarkable balance across all tx and control on both lymph and non lymph Description of participants: Demographics -Age -Education -Ethnicity We are balanced between treatment groups for age, educ status & ethnicity. The age range was 36-80 years of age. Average age overall around 55 years. Well educated group of survivors. Greater than 80% had at least some college or higher. Interesting to see slightly higher rates that completed college in the non lymph group. In the orange we have demo data on those w/lypmph etc. If you scale down you see remarkable balance across all tx and control on both lymph and non lymph Description of participants: Demographics -Age -Education -Ethnicity We are balanced between treatment groups for age, educ status & ethnicity. The age range was 36-80 years of age. Average age overall around 55 years. Well educated group of survivors. Greater than 80% had at least some college or higher. Interesting to see slightly higher rates that completed college in the non lymph group.

13. Baseline strength and body size in women WITH lymphedema

14. Baseline strength and body size in women WITHOUT lymphedema

15. Baseline Lymphedema Characteristics Remove stand deviation, make type biggerRemove stand deviation, make type bigger

16. Intervention adherence With lymphedema 88% average attendance Without lymphedema 79% average attendance Break this out by wave too (wave 1, compared to 2-5) or wave 1&4 vs 2,3,5 Explain waves 1 low resource grp, we expect higher adherence in other grps Try to get up through wave 5 (if time permits) – will ask amy to help Question for Katie: Since max # of session is supposed to be 104 (do we count values over 104 – aren’t these skewing results?)Break this out by wave too (wave 1, compared to 2-5) or wave 1&4 vs 2,3,5 Explain waves 1 low resource grp, we expect higher adherence in other grps Try to get up through wave 5 (if time permits) – will ask amy to help Question for Katie: Since max # of session is supposed to be 104 (do we count values over 104 – aren’t these skewing results?)

17. Strength changes in women WITH lymphedema

18. Strength changes in women WITHOUT lymphedema

19. Lymphedema outcomes in women WITH lymphedema

20. Lymphedema outcomes in women WITHOUT lymphedema

21. Summary Twice weekly slowly progressive strength training is SAFE for breast cancer survivors who have had lymph node removal including Those WITH lymphedema Those AT RISK FOR lymphedema Risk of lymphedema flare-ups decreased by HALF Strength improvements with this program are substantive

22. Development of the Body Image and Relationships Survey Kathryn Schmitz, PhD, MPH Assistant Professor, Principal Investigator Division of Clinical Epidemiology Center for Clinical Epidemiology and Biostatistics University of Pennsylvania School of Medicine

23. Outline Development of the BIRS Part II: effects of weight training on BIRS (Speck)

24. Health Related Quality of Life and Breast Cancer Many domains Many instruments Body image less well studied

25. Development of Body Image and Relationships Survey Born of necessity Weight training for breast cancer survivors study (Ahmed et al. 2006, Ohira et al. 2006, Schmitz et al. 2005) QOL survey = CARES-SF Anecdotal comments from participants Improved Strength, endurance Body image Physical appearance Feeling ‘sexy’ Marital relationships Physicality –wanting to be hugged and touched Openness and camaraderie

26. BIRS development Year 1 of PAL trial Development of initial version Review of existing surveys Review of anecdotal comments from WTBS Survey with 19 questions developed

27. Original questions During the past month: I have been satisfied with my sex life or my lack of a sex life I have been satisfied with my appearance I have felt sexually attractive “Having sex” was an important part of my life I enjoyed sexual activity I was too tired to have sex I wanted to have sex with my partner(s) I have been interested in close physical contact such as hugs and kisses I have had close physical contact with my family and close friends I was embarrassed to show my body to others I was uncomfortable showing my scars to others I was uncomfortable with the changes in my body 7 more items for those who were not sexually active

28. Focus Group Feedback Focus groups with 21 survivors right after they took survey WE HAD IT ALL WRONG Survey revised substantively

29. BIRS Description 32 questions Likert scale Recall over past month

30. BIRS: 1 of 3 Lack of energy prevented me from doing things I wanted to do I had enough energy to do the things I wanted to do I was uncomfortable with or embarrassed by my lack of energy I felt physically capable of all the things I wanted to do My body was strong I felt physically fit My body felt healthy to me I felt physically powerful Being out of shape prevented me from doing things I wanted to do The things that determined my health felt beyond my control I felt embarrassed or uncomfortable because I was out of shape I felt confident I could make myself stronger

31. BIRS: 2 of 3 I restricted my social activities because of my hot flashes Hot flashes prevented me from doing things I wanted to do I restricted my social activities because of changes in my appearance that I attribute to breast cancer surgery Changes in my physical appearance that I attribute to my breast cancer surgery prevented me from doing things I wanted to do I restricted my social activities because of my physical appearance I was embarrassed by my hot flashes I restricted my social activity because of physical symptoms that I attribute to my breast cancer treatment (surgery, chemotherapy, or radiation) I was uncomfortable with or embarrassed by physical symptoms that I attribute to my breast cancer treatment (surgery, chemotherapy, or radiation)

32. BIRS: 3 of 3 I have felt sexually attractive I was uncomfortable with or embarrassed by changing clothes or showering in the women’s locker room of a fitness facility I was uncomfortable with or embarrassed by the appearance of my body My body felt natural to me I was embarrassed by changes to my physical appearance that I attribute to my breast cancer surgery My body felt whole to me I have been satisfied with my sex life I was comfortable changing clothes and showering in the women’s locker room of a fitness facility I was comfortable with the appearance of my body I felt like I had some control over how healthy I was Sexual activity was an important part of my life

33. BIRth of the BIRS Cognitive interviews with 10 survivors WE GOT IT RIGHT THIS TIME Formatting Psychometric assessment in 96 survivors Test-retest Comparison to other common QOL surveys

34. Reliability and internal consistency All 32 questions were reliable (mean rho = 0.65) Chronbach’s alpha = 0.94 for both administrations Removal of any item did NOT improve alpha, all items retained

35. Principal Axis Factoring 3 major factors identified Strength and health Social Barriers Appearance and Sexuality

36. Strength and Health Perceived physical impairment due to treatment Decreased energy Feeling ‘weak’ or ‘unhealthy’ Lack of subjective control over health and strength 12 items Higher score is worse Range 0-60

37. Social Barriers Perceived impairment in social interactions Reduced social activity due to or embarrassment about Physical symptoms Psychological symptoms 9 items Higher score is worse Range 0-45

38. Appearance and Sexuality Decreased enjoyment of and satisfaction with sexual activity Embarrassment about physical appearance Altered perception of one’s body as ‘whole’ and ‘natural’ 11 items Higher score is worse Range 0-55

39. Convergent/Divergent Validity Comparison to many other domains of QOL Ideally Some correlation Not high correlations

40. Comparative QOL Surveys Coopersmith Self-Esteem Inventory Fatigue Symptom Inventory Happiness Scale Life Orientation Test MOS- Social Support MOS SF-36 Pearlins’ Personal Mastery Scale Pittsburgh Sleep Quality Index Visual Analog Scale QOL Temporal Satisfaction with Life Scale

41. Shared variance Average 17.7% Range 5.8% to 42.3% Not high enough to suggest significant conceptual overlap

42. Correlation matrix

43. Conclusions The Body Image and Relationships Survey shows acceptable psychometric properties Measures domains of interest to survivors Can and should be used to test interventions to improve body image Translation work underway…

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