Massage Therapy and Port-a-Catheter Insertion
|Cancer Anxiety Pain Surgery||Other: Massage Therapy Other: Attention Control||Phase 1|
|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|
- 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 ]
- Effects of massage on the duration of the surgical procedure [ Time Frame: Time of surgery ]
- Effect of massage on the amount of anesthesia used during the surgical procedure [ Time Frame: Time of surgery ]
- Related costs of providing massage therapy to patients undergoing port-a-cath implantation [ Time Frame: Day of surgery ]
|Study Start Date:||February 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991770
|United States, Massachusetts|
|Boston Medical Center - Ambulatory Surgery|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Jennifer E Rosen, MD, FACS||Boston Medical Center|