Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2009-02-28
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Massage Therapy
Massage therapy provided by a certified Massage Therapist
Massage Therapy
Two 20 minute chair massages: one before surgery and one after
Control
Empathic support conversation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Massage Therapy
Two 20 minute chair massages: one before surgery and one after
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Massage Therapy Foundation
OTHER
Boston Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jennifer Rosen
Assistant Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer E Rosen, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Boston Medical Center - Ambulatory Surgery
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H27681
Identifier Type: -
Identifier Source: org_study_id