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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

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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 l.jpg
This work was supported by a grant from Postoperative Pain in Cancer Patients Undergoing Port Implantation

Massage Therapy Foundation500 Davis Street, Suite 900Evanston, IL 60201Phone: (847)869-5019Fax: (847)864-1178

www.massagetherapyfoundation.org


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Rationale Postoperative Pain in Cancer Patients Undergoing Port Implantation

  • 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.


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Cancer chemotherapy treatment options Postoperative Pain in Cancer Patients Undergoing Port Implantation

  • Peripheral IV’s

  • PICC lines

  • port


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Implantable venous access device (aka port) Postoperative Pain in Cancer Patients Undergoing Port Implantation

  • Permanent intravenous device (IV)

    • Delivers chemotherapy

    • Allows repeated withdrawal of blood samples


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

Ports…


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Boston Medical Center cancer patients who received port implantation


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Boston Medical Center cancer patients who received port implantation


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Boston Medical Center cancer patients who received port implantation


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Boston Medical Center: Moakley Building cancer patients who received port implantation


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Boston Medical Center: cancer patients who received port implantationMoakley Building Preoperative Suite


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Boston Medical Center: cancer patients who received port implantationMoakley Building Preoperative Suite


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Boston Medical Center: cancer patients who received port implantationMoakley Building Preoperative SuiteEntry into the operating room

Outpatient surgical procedure


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Boston Medical Center: cancer patients who received port implantationMoakley Building Operative Suite

Uses local anesthetic only


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Boston Medical Center: cancer patients who received port implantationMoakley 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


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Boston Medical Center: cancer patients who received port implantationMoakley Building Operative Suite


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Boston Medical Center: cancer patients who received port implantationMoakley Building Operative Suite


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Boston Medical Center: cancer patients who received port implantationMoakley Building Operative Suite


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Boston Medical Center: cancer patients who received port implantationMoakley Building Operative Suite


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Port implantation cancer patients who received port implantation


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Outcomes of Procedure cancer patients who received port implantation

  • 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


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CAM Survey: Descriptive Data cancer patients who received port implantation

CancerDiagnosis (N = 45)

N = 54

  • Male: 43%/Female 57%

  • Have a PCP: 94%

  • Diabetic: 16%

  • High BP: 39%

  • High Cholesterol: 34%


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Demographics cancer patients who received port implantation

Education

MaritalStatus

Income


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Poor cancer patients who received port implantation

Excellent

10%

19%

Fair

27%

Good

44%

Patient Health Ratings

N=52

One person rated themselves both of Good and Fair health


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Why Are You Here Today? cancer patients who received port implantation

33% other

55% getting treated

8% done with treatment

4% about to get treatment

N=52


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CAM Facts cancer patients who received port implantation

  • Used at least one CAM ever: 80%

    - 36% Male

    - 64% Female

  • Used CAM in past 12 months: 41%


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Multivitamins: 27 people cancer patients who received port implantation

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


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CAMs used in last 12 months cancer patients who received port implantation

  • 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.


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Massage therapy cancer patients who received port implantation

  • Excluding prostatic massage, only 100

  • Excluding treatment for lymphedema, only 70

  • Periprocedural: mostly biopsy, cardiac catheterization


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Study Aims cancer patients who received port implantation

  • 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


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Study cancer patients who received port implantation

  • 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


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Study Population cancer patients who received port implantation

  • 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


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Subject Recruitment cancer patients who received port implantation

  • 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


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Intervention: randomization cancer patients who received port implantation

  • Massage Therapy

  • Control = Empathic Support Conversation


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Massage Therapy Protocol cancer patients who received port implantation

  • 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


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Massage Therapy cancer patients who received port implantation

  • Licensed Professional Massage Therapist

  • Twenty minute pre-procedure massage, twenty minute post-procedure massage


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Pre port massage – 20 minutes cancer patients who received port implantation

  • 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.


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Post port massage – 20 minutes cancer patients who received port implantation

  • 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.


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Control cancer patients who received port implantation

  • 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.


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Boston Medical Center: Massage Therapy Trial cancer patients who received port implantation


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Boston Medical Center: Massage Therapy Trial cancer patients who received port implantation


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Boston Medical Center: Massage Therapy Trial cancer patients who received port implantation


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Boston Medical Center: Massage Therapy Trial cancer patients who received port implantation


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Boston Medical Center: Massage Therapy Trial cancer patients who received port implantation


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Study instruments cancer patients who received port implantation

  • 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


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Data Collection: cancer patients who received port implantation

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)


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Primary Outcomes cancer patients who received port implantation

  • Feasibility Measures

    • Time to recruit 60 subjects

    • Retention

    • % racial/ethnic minorities

  • Pain (0-10) scale

  • Anxiety (STAI scale)


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Secondary Outcomes cancer patients who received port implantation

  • Pain Medication Use

  • Adverse Events


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Covariates Measured cancer patients who received port implantation

  • Sociodemographics

  • Expectations surrounding massage and empathic control


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Assessed for eligibility cancer patients who received port implantation

(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)


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Baseline Characteristics: cancer patients who received port implantation

  • 17 males, 16 females (N=33)

  • Mean age 54.75 (range 28-84)


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Baseline Characteristics: cancer patients who received port implantation

Education

Income

Insurance


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Baseline Characteristics cancer patients who received port implantation


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Baseline characteristics: cancer patients who received port implantation

Race

Hispanic identification

Language spoken


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Baseline characteristics cancer patients who received port implantation

Experience with massage

Preference

Expectations of helpfulness of interventions

Rating of overall health


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34 patients randomized cancer patients who received port implantation

2 patients received postoperative intervention only

4 patients dropped out after first intervention

3 dropped out of intervention but participated in data collection

1 dropped out of both intervention and data collection

Adherence:


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No adverse events cancer patients who received port implantation

Interim analysis currently in progress

No major deviations

Feasibility: anticipate completion of recruitment to 60 patients within 5 months

Study Outcomes:


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Change in staff: cancer patients who received port implantation

Massage Therapist

Research Assistant

Maternity Leave of the principal investigator

IRB approval 

Higher percentage of non-English speaking patients than expected.

short form for IRB consent 

Scheduling and conduct issues

OR efficiency

Late arrivals

OR holding area – precious commodity

Staff/nursing buy-in

Massage Therapist availability, pay by block time

Challenges


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Limitations cancer patients who received port implantation

  • Control

  • Small sample size

  • Blinding

  • Use of self-report measures


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Massage therapy for perioperative pain and anxiety in low income minority population is feasible

Conclusions


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Future research income minority population is feasible

  • Adequately powered randomized controlled comparative effectiveness study of massage therapy versus usual care

    • Serum markers/mechanism of action

    • Additional stressors i.e. medicolegal

    • Longer-term study incorporating self-taught or caregiver massage and overall cancer care outcome

  • Extend to additional perioperative settings

    • Thyroid surgery

    • Outpatient procedures i.e. biopsies


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Thanks to our program project team: income minority population is feasible

  • Robert Saper MD MPH (Co-investigator)

  • Michele Bouchard, LMT, NCBTMB (Massage Therapist)

  • Lynne Mullen, LMT (Massage Therapist)

  • Rebecca L. Lawrence, MSW/MPH (Research Assistant)

  • Paula Gardiner MD (CIM researcher)

  • Gheorghe Doros PhD (biostatistician)


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