Massage Therapy and Port-a-Catheter Insertion

Effect of Massage Therapy on Preoperative Anxiety and Postoperative Pain in Cancer Patients Undergoing Port Implantation

The purpose of this study is to assess 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-a-Catheter.

Study Overview

• Status: Completed
• Conditions: Pain; Cancer; Anxiety; Surgery
• Intervention / Treatment: Other: Massage Therapy; Other: Attention Control

Detailed Description

Despite major advances in the understanding of cancer and its treatment, patients continue to suffer greatly. Massage is now included in the National Comprehensive Cancer Network guidelines for the treatment of refractory cancer pain (1), and many cancer patients are turning to massage and other complementary therapies to help alleviate both their psychological and physical symptoms. However, complementary therapies, such as massage, are often unaffordable or unavailable to predominantly low-income cancer patients at safety net hospitals like Boston Medical Center.

The vast majority of cancer patients receiving chemotherapy undergo implantation of a permanent central venous access device, often referred to as a port implantation or implanted port. Although the implanted port carries multiple benefits for ease of treatment, after the procedure patients often complain of headaches, muscle stiffness and neck and shoulder pain that lasts for several days. Pain medication is the only therapy commonly offered for this and is often inadequate (2). Furthermore, since this is often the first surgical procedure for cancer patients at the beginning of their treatment, they often have significant levels of pre-procedure anxiety (3,4). Safe, efficacious, and cost-effective interventions that can reduce the anxiety and pain related to port implantation are needed.

This pilot study will look at how feasible and effective massage therapy is in reducing pre-operative anxiety and post-operative pain among BMC patients already undergoing surgical placement of an implanted port.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center - Ambulatory Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must be adults within one month of diagnosis with any form of cancer.
• Patients must be scheduled to undergo, but have not yet received, port implantation.
• Patients must have the ability to understand and sign a written informed consent.

Exclusion Criteria:

• Patients who are unable or unwilling to provide consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Massage Therapy; Massage therapy provided by a certified Massage Therapist	Other: Massage Therapy; Two 20 minute chair massages: one before surgery and one after
Active Comparator: Control; Empathic support conversation	Other: Attention Control; Two 20 minute sessions where the Massage Therapist will talk to the patient about how they are feeling, listen, and provide empathetic support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of massage therapy for reducing pre-operative anxiety among predominantly low income minority cancer patients undergoing surgical placement of an implanted port.	Baseline (prior to first 20 min intervention) and post-intervention/pre-surgery
Efficacy of massage therapy for reducing post-operative pain among predominantly low income minority cancer patients undergoing surgical placement of an implanted port.	Post-surgery/pre-second 20 min intervention and post-surgery/post-second 20 min intervention
Feasibility of using massage therapy to reduce pre-operative anxiety and post-operative pain among predominantly low income minority cancer patients undergoing surgical placement of an implanted port.	Day of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Effects of massage on the duration of the surgical procedure	Time of surgery
Effect of massage on the amount of anesthesia used during the surgical procedure	Time of surgery
Related costs of providing massage therapy to patients undergoing port-a-cath implantation	Day of surgery

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Massage Therapy Foundation
• Investigators: Principal Investigator: Jennifer E Rosen, MD, FACS, Boston Medical Center

Publications and helpful links

General Publications

• Vardy J, Engelhardt K, Cox K, Jacquet J, McDade A, Boyer M, Beale P, Stockler M, Loneragan R, Dennien B, Waugh R, Clarke SJ. Long-term outcome of radiological-guided insertion of implanted central venous access port devices (CVAPD) for the delivery of chemotherapy in cancer patients: institutional experience and review of the literature. Br J Cancer. 2004 Sep 13;91(6):1045-9. doi: 10.1038/sj.bjc.6602082.
• Bow EJ, Kilpatrick MG, Clinch JJ. Totally implantable venous access ports systems for patients receiving chemotherapy for solid tissue malignancies: A randomized controlled clinical trial examining the safety, efficacy, costs, and impact on quality of life. J Clin Oncol. 1999 Apr;17(4):1267. doi: 10.1200/JCO.1999.17.4.1267.
• Silvestri V, Nerini L, Missio G, Masini M, Faggi S, Gori A, Panella M. Levels of anxiety and pain during chemotherapy with peripheral versus central vascular access: an experimental evaluation. J Vasc Access. 2004 Oct-Dec;5(4):147-53. doi: 10.1177/112972980400500403.
• Benedetti C, Brock C, Cleeland C, Coyle N, Dube JE, Ferrell B, Hassenbusch S 3rd, Janjan NA, Lema MJ, Levy MH, Loscalzo MJ, Lynch M, Muir C, Oakes L, O'Neill A, Payne R, Syrjala KL, Urba S, Weinstein SM; National Comprehensive Cancer Network. NCCN Practice Guidelines for Cancer Pain. Oncology (Williston Park). 2000 Nov;14(11A):135-50.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 6, 2009
• First Submitted That Met QC Criteria: October 7, 2009
• First Posted (Estimate): October 8, 2009

Study Record Updates

• Last Update Posted (Estimate): December 7, 2011
• Last Update Submitted That Met QC Criteria: December 6, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Massage; Complementary and Alternative Medicine; Discomfort; Port-a-Catheters
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: H27681