- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02152020
Patient-Centered Acupuncture for Pain (PCAP)
January 13, 2015 updated by: Abramson Cancer Center of the University of Pennsylvania
Patient-Centered Integration of Acupuncture to Decrease Pain for Cancer Survivors
The objective of this study is to find out if acupuncture can improve the management of pain in cancer patients when used as part of a treatment plan that includes conventional pain medications.
The investigators will enroll 36 cancer patients at Abramson Cancer Center and Penn Cancer Network sites.
Participants will be enrolled in either the Conventional Pain Management group or Integrative Pain Management group.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
36
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
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
All
Sampling Method
Probability Sample
Study Population
Cancer survivors 18 years or older with pain ratings of 4 or greater on a 0-10 numerical rating scale; primary diagnosis of cancer (stages I-III); finished primary cancer treatment; Karnofsky score 60 or greater; and who have been taking pain medications daily.
Description
Inclusion Criteria:
- Women or men age 18 years or older
- Primary diagnosis of cancer with history of stage I, II, or III cancer
- Finished primary cancer treatments (surgery, chemotherapy, radiotherapy)
- Have a Karnofsky score of 60 or greater
- Can understand written English
- Have worst pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week
- Have been taking pain medications daily
- Have had at least 15 days with pain in the preceding 30 days.
Exclusion Criteria:
- Women or men with metastatic (stage IV) cancer
- Unstable and progressive medical conditions as judged by the PIs or designated research nurse at the community hospitals (e.g., progressive cancer, uncontrolled heart failure) that may require hospitalization in the next 12 weeks
- Planned surgical procedures in the next 12 weeks
- Patients currently in a pain crisis as judged by the PI or designated research nurse that may warrant acute titration of medications or hospitalization
- Women who are pregnant or breastfeeding
- Unwillingness to adhere to study related procedures.
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
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cancer survivors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Adverse Events
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
May 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
May 29, 2014
First Submitted That Met QC Criteria
May 30, 2014
First Posted (Estimate)
June 2, 2014
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- UPCC 01914
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.
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