Effects of Massage Therapy on Preoperative Anxiety and Postoperative Pain in Cancer Patients Undergoing Port Implantatio

1. Effects of Massage Therapy on Preoperative Anxiety and Postoperative Pain in Cancer Patients Undergoing Port Implantation Jennifer E. Rosen, MD FACS (Principal Investigator)

2. This work was supported by a grant from Massage Therapy Foundation500 Davis Street, Suite 900Evanston, IL 60201Phone: (847)869-5019Fax: (847)864-1178 www.massagetherapyfoundation.org

3. Rationale • At Boston Medical Center, cancer patients often enter care with significantly larger tumors than patients at other nearby Boston hospitals. • Experience debilitating side effects and lower quality of life (QOL) 1 • Exacerbated for racial/ethnic minorities • Treatment often proves unaffordable or is inaccessible to our low-income patients 1. Garcia, S.F., et al., Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol, 2007. 25(32): p. 5106-12. 2. McNeill, J.A., J. Reynolds, and M.L. Ney, Unequal quality of cancer pain management: disparity in perceived control and proposed solutions. Oncol Nurs Forum, 2007. 34(6): p. 1121-8.

4. Cancer chemotherapy treatment options • Peripheral IV’s • PICC lines • port

5. Implantable venous access device (aka port) • Permanent intravenous device (IV) • Delivers chemotherapy • Allows repeated withdrawal of blood samples

6. In 2006 and 2007, there were approximately 225 and 250 cancer patients who received port implantation at BMC Ports…

7. Boston Medical Center

8. Boston Medical Center

9. Boston Medical Center

10. Boston Medical Center: Moakley Building

11. Boston Medical Center: Moakley Building Preoperative Suite

12. Boston Medical Center: Moakley Building Preoperative Suite

13. Boston Medical Center: Moakley Building Preoperative SuiteEntry into the operating room Outpatient surgical procedure

14. Boston Medical Center: Moakley Building Operative Suite Uses local anesthetic only

15. Boston Medical Center: Moakley Building Operative Suite • Patients remain conscious, keep their head rotated 90 degrees to one side and remain very still during this delicate procedure, which takes approximately 60 min

16. Boston Medical Center: Moakley Building Operative Suite

17. Boston Medical Center: Moakley Building Operative Suite

18. Boston Medical Center: Moakley Building Operative Suite

19. Boston Medical Center: Moakley Building Operative Suite

20. Port implantation

21. Outcomes of Procedure • Headaches, muscle stiffness and neck and shoulder pain • Often the first surgical procedure for cancer patients at the beginning of their treatment, they often have significant levels of pre-procedure anxiety • Need for safe, efficacious, and cost-effective interventions to reduce anxiety and pain related to port placement

22. CAM Survey: Descriptive Data CancerDiagnosis (N = 45) N = 54 • Male: 43%/Female 57% • Have a PCP: 94% • Diabetic: 16% • High BP: 39% • High Cholesterol: 34%

23. Demographics Education MaritalStatus Income

24. Poor Excellent 10% 19% Fair 27% Good 44% Patient Health Ratings N=52 One person rated themselves both of Good and Fair health

25. Why Are You Here Today? 33% other 55% getting treated 8% done with treatment 4% about to get treatment N=52

26. CAM Facts • Used at least one CAM ever: 80% - 36% Male - 64% Female • Used CAM in past 12 months: 41%

27. Multivitamins: 27 people Prayer: 18 people Herbal Tea: 17 people Chiropraxy/Massage: 14 people Herbal supplements or chinese herbs: 11 people Spiritual or religious healing: 10 people Cod liver oil: 9 people Garlic: 7 people Home/ fold remedies, poultices: 7 people Wore something: 6 people Ate a special diet: 6 people Homeopathic meds: 5 people Aloe: 5 people Acupuncture: 4 people Hypnosis, meditation, or yoga: 4 people Other types of special diets: 3 people Valerian (all heal), Ginseng, and Cascara: 2 people for each CAMs Used Only one person used each of the following:Ayurveda, Chelation therapy, Coral calcium, Ephedra (ma huang), Flax seed oil, Ginger, Gogi, Nutrition drinks, Pinea rice, Primrose oil, and Wheat grass

28. CAMs used in last 12 months • Used CAM in past 12 months: 41% - excluding multivitamin use : 37% - excluding prayer : 39% - excluding prayer and multivitamin use: 35% • Of those people that had used CAM in past 12 months, 68% (15/22) had used more than one CAM therapy.

29. Massage therapy • Excluding prostatic massage, only 100 • Excluding treatment for lymphedema, only 70 • Periprocedural: mostly biopsy, cardiac catheterization

30. Study Aims • Primary: to determine the feasibility and efficacy of massage therapy for reducing pre-operative anxiety and post-operative pain among predominantly low income minority cancer patients undergoing surgical placement of a port • Secondary: assess duration of surgical procedure, amount of anesthetic used, and related costs

31. Study • 9 month randomized clinical trial • 60 Patients • 2:1 Randomization (Massage Therapy or Control) • Data collection blinded to study group, massage therapist blinded to data collection, surgeon blinded to both

32. Study Population • Inclusion • 18 years of age and older • All languages and ethnicities • Within one month of cancer diagnosis • Scheduled to undergo, but have not yet received, port implantation by Dr. Jennifer Rosen • Have the ability to understand and sign a written informed consent • Exclusion • Unable or unwilling to provide consent

33. Subject Recruitment • Boston Medical Center • All patients undergoing port insertion by Dr. Jennifer Rosen identified from her operative bookings • During time frame that massage therapist was available • Copy of consent form and Baseline Questionnaire mailed to patients scheduled for the port-a-cath procedure • Contact patients one day prior to surgery to assess interest and to have them come in at least 1 hour prior to scheduled surgery

34. Intervention: randomization • Massage Therapy • Control = Empathic Support Conversation

35. Massage Therapy Protocol • Constituted panel of two licensed massage therapists and an expert in CIM clinical trials along with the principal investigator • Systematic review of lay and scientific literature on massage therapy for periprocedural pain and anxiety • Panel members reviewed all materials • Panel members went into operating room to observe a series of actual port implantations, then met to revise massage therapy protocol based on their experience • Panel met twice to draft protocol based upon their experience and the literature • Iterative revisions and consensus

36. Massage Therapy • Licensed Professional Massage Therapist • Twenty minute pre-procedure massage, twenty minute post-procedure massage

37. Pre port massage – 20 minutes • Patient is supine in bed or chair. Effleurage strokes from hand to shoulders 3 times. Effleurage shoulder joint 3 times. Gentle compression to shoulders. Slide back down to hand. • Hand massage acupressure points LI 4, P6 • Repeat as above on the other side. • Gently rock down body to feet. Foot Massage each foot accessing reflex points spinal, neck, shoulder chest and solar plexus. • Finish with hold.

38. Post port massage – 20 minutes • Patient is in chair or bed, supine. Begin with Cranial Balance and cradle hold. • Gentle finger tip massage whole scalp up to the forehead. • Light stroking effleurage over the forehead. • Circular light strokes over the temple region, finishing with a slight compression hold. • Effleurage down sides of neck with gentle strokes. • Gently light downward pressure to shoulders and finish with a cranial hold. • Effleurage shoulder to fingertips 3 times • Shoulders down the arms through the hands: compression holds 3 times. • Hand massage acupressure points LI 4, P 6 • Repeat on the other side. • If time allows hold feet, apply gentle compression.

39. Control • Empathic Support Conversation Lang EV et al; Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. The Lancet Vol. 355 April 19 2000 pp 1486-1490.

40. Boston Medical Center: Massage Therapy Trial

41. Boston Medical Center: Massage Therapy Trial

42. Boston Medical Center: Massage Therapy Trial

43. Boston Medical Center: Massage Therapy Trial

44. Boston Medical Center: Massage Therapy Trial

45. Study instruments • Self-reported health • Sociodemographics: age, gender, diagnosis, insurance status, income, language spoken, religious preference, country of origin, etc. • Expectations regarding massage and control for pain and anxiety • STAI (State Trait and Anxiety Inventory) • Likert 11 point pain scale

46. Data Collection: Informed Consent and Baseline Questionnaire Time 1: Preoperative 20 Min Intervention Time 2: Preoperative post first intervention Pain scale and State Trait Anxiety Inventory (STAI) Surgery: Port Insertion (45-60 min) Pain scale and State Trait Anxiety Inventory (STAI) Time 3: Postoperative pre-second intervention 20 Min Intervention Time 4: Postoperative post-second intervention Pain scale and State Trait Anxiety Inventory (STAI) Time 5: One day later Pain scale and State Trait Anxiety Inventory (STAI)

47. Primary Outcomes • Feasibility Measures • Time to recruit 60 subjects • Retention • % racial/ethnic minorities • Pain (0-10) scale • Anxiety (STAI scale)

48. Secondary Outcomes • Pain Medication Use • Adverse Events

49. Covariates Measured • Sociodemographics • Expectations surrounding massage and empathic control

50. Assessed for eligibility (n=52) Excluded (n=18) Did not meet inclusion criteria (n=13 ) Declined to participate (n=5 ) Randomized (n=34) Massage Therapy (n=26 ) Control (n=8 ) Participant Flow Chart Sample for Analysis: Baseline (n=34) Pre-Surgery (n=30) Post-Surgery 1 (n=33) Post-Surgery 2 (n=27) Post-Surgery 3 (n=15)