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Clinical Trials/NCT00991770
NCT00991770
Completed
Phase 1

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

Boston Medical Center1 site in 1 country60 target enrollmentFebruary 2009

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cancer
Sponsor
Boston Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Efficacy of massage therapy for reducing pre-operative anxiety among predominantly low income minority cancer patients undergoing surgical placement of an implanted port.
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
October 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Rosen

Assistant Professor of Medicine

Boston Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Efficacy of massage therapy for reducing pre-operative anxiety among predominantly low income minority cancer patients undergoing surgical placement of an implanted port.

Time Frame: 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.

Time Frame: 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.

Time Frame: Day of surgery

Secondary Outcomes

  • 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)

Study Sites (1)

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