Clinical trial NCT00991770: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Anxiety
Pain
Surgery
Keywords: Discomfort
Port-a-Catheters
Complementary and Alternative Medicine
Massage
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Massage Therapy Foundation
First posted: 2009-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy of massage therapy for reducing pre-operative anxiety among predominantly low income minority cancer patients undergoing surgical placement of an implanted port.
timeFrame: Baseline (prior to first 20 min intervention) and post-intervention/pre-surgery
measure: Efficacy of massage therapy for reducing post-operative pain among predominantly low income minority cancer patients undergoing surgical placement of an implanted port.
timeFrame: Post-surgery/pre-second 20 min intervention and post-surgery/post-second 20 min intervention
measure: 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.
timeFrame: Day of surgery
Secondary outcomes:
measure: Effects of massage on the duration of the surgical procedure
timeFrame: Time of surgery
measure: Effect of massage on the amount of anesthesia used during the surgical procedure
timeFrame: Time of surgery
measure: Related costs of providing massage therapy to patients undergoing port-a-cath implantation
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center - Ambulatory Surgery
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Jennifer E Rosen, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.