Massage Therapy and Port-a-Catheter Insertion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Massage Therapy on Preoperative Anxiety and Postoperative Pain in Cancer Patients Undergoing Port Implantation

Conditions
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Cancer, Anxiety, Pain, Surgery

Intervention / Treatment
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* Other: Massage Therapy
* Other: Attention Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Massage Therapy<br>Massage therapy provided by a certified Massage Therapist | Other: Massage Therapy<br>* Two 20 minute chair massages: one before surgery and one after<br>|
| Active Comparator: Control<br>Empathic support conversation | Other: Attention Control<br>* Two 20 minute sessions where the Massage Therapist will talk to the patient about how they are feeling, listen, and provide empathetic support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of massage therapy for reducing pre-operative anxiety among predominantly low income minority cancer patients undergoing surgical placement of an implanted port. |  | 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. |  | 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. |  | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of massage on the duration of the surgical procedure |  | Time of surgery | 
| Effect of massage on the amount of anesthesia used during the surgical procedure |  | Time of surgery | 
| Related costs of providing massage therapy to patients undergoing port-a-cath implantation |  | Day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Discomfort, Port-a-Catheters, Complementary and Alternative Medicine, Massage