- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00322504
Acupuncture for Anxiety in Women With Breast Cancer: A Feasibility Study
January 6, 2010 updated by: University of New Mexico
To assess the efficacy of acupuncture treatment in reducing symptoms of anxiety in women recently diagnosed with cancer.
• To assess the efficacy of acupuncture treatment on improving perceived quality of life in women recently diagnosed with cancer.
Study Overview
Detailed Description
This is a feasibility study of acupuncture for anxiety reduction in women with breast cancer.
Ten patients will be recruited at the UNM Cancer Research Treatment Center via the Breast Clinic and screened for anxiety.
Treatment will consist of 10 acupuncture sessions over 5 weeks.
Measures (Hopkins Symptom Checklist, Sheehan Disability Index) will be administered and analyzed for treatment effect on scores.
Study Type
Interventional
Enrollment
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87114
- University of New Mexico
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Woman age 18 years or older excluding the need for parental/guardian permission.
- Histologic diagnosis of breast cancer.
- Having a minimum anxiety score of 1.75 on the Hopkins Symptom Checklist (HSCL) with sufficient English language proficiency for the investigators to make this determination.
- Able to give informed consent.
- Willingness to participate in the study and receive 10 acupuncture treatments in 5 weeks.
- Ability to fill out questionnaires and communicate with the research staff
Exclusion Criteria:
- Males with breast cancer
- Psychoses or a major personality disorder
- Current use of opiates,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian Shelley, University of New Mexico
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Completion
September 1, 2006
Study Registration Dates
First Submitted
May 5, 2006
First Submitted That Met QC Criteria
May 5, 2006
First Posted (Estimate)
May 8, 2006
Study Record Updates
Last Update Posted (Estimate)
January 7, 2010
Last Update Submitted That Met QC Criteria
January 6, 2010
Last Verified
November 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INST 0520C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.