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Completed

NCT Number: NCT00991770

Massage Therapy and Port-a-Catheter Insertion

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boston Medical Center - Ambulatory Surgery

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Massage therapy

Other

Two 20 minute chair massages: one before surgery and one after

Attention Control

Other

Two 20 minute sessions where the Massage Therapist will talk to the patient about how they are feeling, listen, and provide empathetic support.

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. Effects of massage on the duration of the surgical procedure

    Time frame: Time of surgery

  2. Effect of massage on the amount of anesthesia used during the surgical procedure

    Time frame: Time of surgery

  3. Related costs of providing massage therapy to patients undergoing port-a-cath implantation

    Time frame: Day of surgery

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Massage Therapy Foundation

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 8, 2009
Registry last updated
Dec 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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