Effects of Massage Therapy on Preoperative Anxiety and Postoperative Pain in Cancer Patients Undergoing Port Implantation Jennifer E. Rosen, MD FACS (Principal Investigator)
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
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.
Cancer chemotherapy treatment options • Peripheral IV’s • PICC lines • port
Implantable venous access device (aka port) • Permanent intravenous device (IV) • Delivers chemotherapy • Allows repeated withdrawal of blood samples
In 2006 and 2007, there were approximately 225 and 250 cancer patients who received port implantation at BMC Ports…
Boston Medical Center: Moakley Building Preoperative SuiteEntry into the operating room Outpatient surgical procedure
Boston Medical Center: Moakley Building Operative Suite Uses local anesthetic only
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
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
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%
Demographics Education MaritalStatus Income
Poor Excellent 10% 19% Fair 27% Good 44% Patient Health Ratings N=52 One person rated themselves both of Good and Fair health
Why Are You Here Today? 33% other 55% getting treated 8% done with treatment 4% about to get treatment N=52
CAM Facts • Used at least one CAM ever: 80% - 36% Male - 64% Female • Used CAM in past 12 months: 41%
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
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.
Massage therapy • Excluding prostatic massage, only 100 • Excluding treatment for lymphedema, only 70 • Periprocedural: mostly biopsy, cardiac catheterization
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
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
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
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
Intervention: randomization • Massage Therapy • Control = Empathic Support Conversation
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
Massage Therapy • Licensed Professional Massage Therapist • Twenty minute pre-procedure massage, twenty minute post-procedure massage
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.
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.
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.
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
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)
Primary Outcomes • Feasibility Measures • Time to recruit 60 subjects • Retention • % racial/ethnic minorities • Pain (0-10) scale • Anxiety (STAI scale)
Secondary Outcomes • Pain Medication Use • Adverse Events
Covariates Measured • Sociodemographics • Expectations surrounding massage and empathic control
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)