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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00991770 |
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Date of registration:
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06/10/2009 |
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Primary sponsor: |
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Public title:
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Massage Therapy and Port-a-Catheter Insertion
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Scientific title:
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Effect of Massage Therapy on Preoperative Anxiety and Postoperative Pain in Cancer Patients Undergoing Port Implantation |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00991770 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Jennifer E Rosen, MD, FACS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boston Medical Center |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anxiety
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Cancer
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Pain
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Surgery
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Intervention(s)
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Other: Attention Control
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Other: Massage Therapy
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Primary Outcome(s)
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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]
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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]
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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]
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Secondary Outcome(s)
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Effect of massage on the amount of anesthesia used during the surgical procedure
[Time Frame: Time of surgery]
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Effects of massage on the duration of the surgical procedure
[Time Frame: Time of surgery]
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Related costs of providing massage therapy to patients undergoing port-a-cath implantation
[Time Frame: Day of surgery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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