Massage Therapy and Port-a-Catheter Insertion
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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 |
- 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 ]
- 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 |
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| United States, Massachusetts | |
| Boston Medical Center - Ambulatory Surgery | |
| Boston, Massachusetts, United States, 02118 | |
| 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 |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013