Massage Therapy and Port-a-Catheter Insertion

NCT00991770 | Completed Phase 1 DMC

• 1 other identifier: H27681
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Anxiety; Pain; Surgery

Keywords

Discomfort; Port-a-Catheters; Complementary and Alternative Medicine; Massage

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (2)

Massage Therapy

EXPERIMENTAL

Massage therapy provided by a certified Massage Therapist

Other: Massage Therapy

Control

ACTIVE COMPARATOR

Empathic support conversation

Other: Attention Control

Interventions

Massage Therapy OTHER

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

Massage Therapy

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who are unable or unwilling to provide consent.

Sponsors & Collaborators

• Boston Medical Center: lead
• Massage Therapy Foundation: collaborator

Study Sites (1)

Boston Medical Center - Ambulatory Surgery

Boston, Massachusetts, 02118, United States

Location

Related Publications (4)

• 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.

  PMID: 15316563 BACKGROUND

• 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.

  PMID: 10561188 BACKGROUND

• 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.

  PMID: 16596558 BACKGROUND

• 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.

  PMID: 11195407 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jennifer E Rosen, MD, FACS

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 8, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 7, 2011

Record last verified: 2011-12

Locations

US (1)