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Massage Therapy and Port-a-Catheter Insertion

Primary Purpose

Cancer, Anxiety, Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Massage Therapy
Attention Control
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Discomfort, Port-a-Catheters, Complementary and Alternative Medicine, Massage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Medical Center - Ambulatory Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Massage Therapy

Control

Arm Description

Massage therapy provided by a certified Massage Therapist

Empathic support conversation

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
October 6, 2009
Last Updated
December 6, 2011
Sponsor
Boston Medical Center
Collaborators
Massage Therapy Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00991770
Brief Title
Massage Therapy and Port-a-Catheter Insertion
Official Title
Effect of Massage Therapy on Preoperative Anxiety and Postoperative Pain in Cancer Patients Undergoing Port Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
Massage Therapy Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Anxiety, Pain, Surgery
Keywords
Discomfort, Port-a-Catheters, Complementary and Alternative Medicine, Massage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Massage Therapy
Arm Type
Experimental
Arm Description
Massage therapy provided by a certified Massage Therapist
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Empathic support conversation
Intervention Type
Other
Intervention Name(s)
Massage Therapy
Intervention Description
Two 20 minute chair massages: one before surgery and one after
Intervention Type
Other
Intervention Name(s)
Attention Control
Intervention Description
Two 20 minute sessions where the Massage Therapist will talk to the patient about how they are feeling, listen, and provide empathetic support.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
Effects of massage on the duration of the surgical procedure
Time Frame
Time of surgery
Title
Effect of massage on the amount of anesthesia used during the surgical procedure
Time Frame
Time of surgery
Title
Related costs of providing massage therapy to patients undergoing port-a-cath implantation
Time Frame
Day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer E Rosen, MD, FACS
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center - Ambulatory Surgery
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15316563
Citation
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.
Results Reference
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PubMed Identifier
10561188
Citation
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.
Results Reference
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PubMed Identifier
16596558
Citation
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.
Results Reference
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PubMed Identifier
11195407
Citation
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.
Results Reference
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Massage Therapy and Port-a-Catheter Insertion

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