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Massage Therapy and Port-a-Catheter Insertion

This study has been completed.
Sponsor:
Collaborator:
Massage Therapy Foundation
Information provided by (Responsible Party):
Jennifer Rosen, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00991770
First received: October 6, 2009
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Cancer
Anxiety
Pain
Surgery
Other: Massage Therapy
Other: Attention Control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Massage Therapy on Preoperative Anxiety and Postoperative Pain in Cancer Patients Undergoing Port Implantation

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects of massage on the duration of the surgical procedure [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
  • Effect of massage on the amount of anesthesia used during the surgical procedure [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
  • Related costs of providing massage therapy to patients undergoing port-a-cath implantation [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Massage Therapy
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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991770

Locations
United States, Massachusetts
Boston Medical Center - Ambulatory Surgery
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Massage Therapy Foundation
Investigators
Principal Investigator: Jennifer E Rosen, MD, FACS Boston Medical Center
  More Information

Publications:
Responsible Party: Jennifer Rosen, Assistant Professor of Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00991770     History of Changes
Other Study ID Numbers: H27681
Study First Received: October 6, 2009
Last Updated: December 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Discomfort
Port-a-Catheters
Complementary and Alternative Medicine
Massage

ClinicalTrials.gov processed this record on November 27, 2014