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

October 6, 2009
December 6, 2011
February 2009
October 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00991770 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cancer
  • Anxiety
  • Pain
  • Surgery
  • Other: Massage Therapy
    Two 20 minute chair massages: one before surgery and one after
    Other Name: Massage Therapy
  • 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
  • Experimental: Massage Therapy
    Massage therapy provided by a certified Massage Therapist
    Intervention: Other: Massage Therapy
  • Active Comparator: Control
    Empathic support conversation
    Intervention: Other: Attention Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00991770
H27681
Yes
Jennifer Rosen, Boston Medical Center
Boston Medical Center
Massage Therapy Foundation
Principal Investigator: Jennifer E Rosen, MD, FACS Boston Medical Center
Boston Medical Center
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP